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Transform-Us! cluster RCT: 18-month and 30-month effects on children's physical activity, sedentary time and cardiometabolic risk markers.
Salmon, J, Arundell, L, Cerin, E, Ridgers, ND, Hesketh, KD, Daly, RM, Dunstan, D, Brown, H, Della Gatta, J, Della Gatta, P, et al
British journal of sports medicine. 2023;57(5):311-319
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Regular physical activity is beneficial to children’s physical, social and mental health. However, most children fail to meet the recommended 60+ min of moderate-intensity to vigorous-intensity physical activity every day. The Transform-Us! school-based and home-based intervention was developed to determine the impact of strategies to promote children’s moderate-to-vigorous physical activity versus reduce sedentary behaviour or a combination of these strategies, on behavioural and health outcomes. The main aim of this study was to determine the efficacy of the independent and combined intervention approaches to promoting physical activity and reducing sedentary behaviour on children’s moderate-to-vigorous physical activity and sedentary time after 18 and 30 months compared with usual practice. This study is a 30-month 2×2 factorial design cluster randomised controlled trial delivered in 20 primary schools with additional home intervention components. After recruitment, schools were then randomly allocated to one of four groups. Results show that Transform-Us! had stronger effects on children’s sedentary behaviour than physical activity in both the physical activity (PA) and sedentary behaviour (SB) interventions, and there were beneficial effects on children’s adiposity for both intervention approaches. However, no clear conclusions could be drawn regarding which intervention (PA or SB) had the strongest or more consistent effects on children’s health outcomes. Authors conclude that, based on their findings, government education departments and schools should consider adopting and implementing whole-of-school programmes to promote children’s physical activity and reduce sitting through active pedagogy and supportive social and physical environments at school and home to benefit children’s sedentary time and some markers of cardiometabolic health.
Abstract
OBJECTIVE To test the efficacy of the Transform-Us! school- and home-based intervention on children's physical activity (PA), sedentary behaviour (SB) and cardiometabolic risk factor profiles. METHODS A 30-month 2×2 factorial design cluster randomised controlled trial delivered in 20 primary schools (148 Year 3 classes) in Melbourne, Australia (2010-2012), that used pedagogical and environmental strategies to reduce and break up SB, promote PA or a combined approach, compared with usual practice. Primary outcomes (accelerometry data; n=348) were assessed at baseline, 18 and 30 months. Secondary outcomes included body mass index (BMI) and waist circumference (WC) (n=564), blood pressure (BP) (n=537) and biomarkers (minimum n=206). Generalised linear mixed models estimated the interactive effects of the PA and SB interventions on the outcomes. If there was no interaction, the main effects were assessed. RESULTS At 18 months, there were intervention effects on children's weekday SB (-27 min, 95% CI: -47.3 to -5.3) for the PA intervention, and on children's average day PA (5.5 min, 95% CI: 0.1 to 10.8) for the SB intervention. At 30 months, there was an intervention effect for children's average day SB (-33.3 min, 95% CI: -50.6 and -16.0) for the SB intervention. Children's BMI (PA and SB groups) and systolic BP (combined group) were lower, and diastolic BP (PA group) was higher. There were positive effects on WC at both time points (SB intervention) and mixed effects on blood parameters. CONCLUSIONS The Transform-Us! PA and SB interventions show promise as a pragmatic approach for reducing children's SB and adiposity indicators; but achieving substantial increases in PA remains challenging. TRIAL REGISTRATION ISRCTN83725066; ACTRN12609000715279.
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Dietary Strawberries Improve Serum Metabolites of Cardiometabolic Risks in Adults with Features of the Metabolic Syndrome in a Randomized Controlled Crossover Trial.
Basu, A, Izuora, K, Hooyman, A, Scofield, HR, Ebersole, JL
International journal of molecular sciences. 2023;24(3)
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Metabolic syndrome has been identified as a major risk factor for type 2 diabetes and its cardiovascular complications. Several dietary strategies, especially the use of different forms of dietary supplements, continue to be investigated for the prevention and management of this condition. The aim of this study was to examine the serum metabolites (targeted and untargeted) that may be affected by strawberry supplementation. This study was a randomised, double-blind, controlled crossover trial which enrolled adult participants with one or more features of metabolic syndrome. Participants were assigned to one of the three arms for four weeks separated by a one-week washout period. Results show that several targeted and untargeted serum metabolites were modulated with strawberry supplementation. In fact, strawberry supplementation improved the serum metabolic profiles which are associated with decreased risks of insulin resistance and diabetes, as well as endothelial dysfunction in adults with features of metabolic syndrome. Authors conclude that adding whole strawberries to the habitual diet may be a beneficial and feasible strategy to improve the cardiometabolic health in adults.
Abstract
Dietary strawberries have been shown to improve cardiometabolic risks in multiple clinical trials. However, no studies have reported effects on serum metabolomic profiles that may identify the target pathways affected by strawberries as underlying mechanisms. We conducted a 14-week randomized, controlled crossover study in which participants with features of metabolic syndrome were assigned to one of the three arms for four weeks separated by a one-week washout period: control powder, 1 serving (low dose: 13 g strawberry powder/day), or 2.5 servings (high dose: 32 g strawberry powder/day). Blood samples, anthropometric measures, blood pressure, and dietary and physical activity data were collected at baseline and at the end of each four-week phase of intervention. Serum samples were analyzed for primary metabolites and complex lipids using different mass spectrometry methods. Mixed-model ANOVA was used to examine differences in the targeted metabolites between treatment phases, and LASSO logistic regression was used to examine differences in the untargeted metabolites at end of the strawberry intervention vs. the baseline. The findings revealed significant differences in the serum branched-chain amino acids valine and leucine following strawberry intervention (high dose) compared with the low-dose and control phases. Untargeted metabolomic profiles revealed several metabolites, including serum phosphate, benzoic acid, and hydroxyphenyl propionic acid, that represented improved energy-metabolism pathways, compliance measures, and microbial metabolism of strawberry polyphenols, respectively. Thus, dietary supplementation of strawberries significantly improves the serum metabolic profiles of cardiometabolic risks in adults.
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Olive pomace oil can improve blood lipid profile: a randomized, blind, crossover, controlled clinical trial in healthy and at-risk volunteers.
González-Rámila, S, Sarriá, B, Seguido, MA, García-Cordero, J, Mateos, R, Bravo, L
European journal of nutrition. 2023;62(2):589-603
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Morbidity and mortality from cardiovascular diseases (CVD) are increasing. It is known that a healthy diet and physical exercise can modulate the risk of CVD. In this regard, the Mediterranean Diet (MD) is considered a model of healthy eating and olive oil is an essential component of this diet, as its primary fat source. The aims of this study were to assess the possible beneficial role of consuming olive pomace oil (OPO) as the main source of fat in the diet on serum lipid concentrations (primary outcome) and other biomarkers of cardiovascular health such as blood pressure, endothelial function and inflammation (secondary outcomes) in at-risk (hypercholesterolaemic) subjects. This study was a randomised, blind, crossover, controlled clinical trial in free-living subjects. Participants, men and women aged 18–55 years, were randomly assigned to one of the two groups; normocholesterolaemic or hypercholesterolaemic group. Results showed that consumption of OPO for four weeks resulted in an improved blood lipid profile, decreasing low-density lipoprotein cholesterol, Apo B and low-density lipoprotein/ high-density lipoprotein ratio both in healthy and at-risk volunteers, in contrast to the opposite effect observed with high-oleic acid sunflower oil (HOSO), with no significant changes in other CVD risk factors. Furthermore, no changes were observed in relation to blood pressure, and biomarkers linked to inflammation and endothelial function. Authors conclude that OPO could have hypolipidemic actions in healthy consumers and in subjects with high blood cholesterol, contributing to cardiovascular disease prevention.
Abstract
PURPOSE This study aimed to assess the effect of dietary consumption of olive pomace oil (OPO) on blood lipids (primary outcome) and other cardiovascular disease (CVD) risk factors (blood pressure, inflammation and endothelial function as secondary outcomes). METHODS A randomized, controlled, blind, crossover intervention was carried out in healthy and at-risk (hypercholesterolemic) subjects. Participants consumed daily 45 g of OPO or high-oleic acid sunflower oil (HOSO) as control oil during 4 weeks. RESULTS OPO significantly reduced low-density lipoprotein cholesterol (LDL-C; P = 0.003) and apolipoprotein B (Apo B; P = 0.022) serum concentrations, and LDL/HDL ratio (P = 0.027) in healthy and at-risk volunteers. These effects were not observed with HOSO. Blood pressure, peripheral artery tonometry (PAT), endothelial function and inflammation biomarkers were not affected. CONCLUSIONS Regular consumption of OPO in the diet could have hypolipidemic actions in subjects at cardiovascular risk as well as in healthy consumers, contributing to CVD prevention. CLINICAL TRIAL REGISTRY NCT04997122, August 8, 2021, retrospectively registered.
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Effect of high intensity interval training on arterial stiffness in obese hypertensive women: a randomized controlled trial.
Taha, MM, Aneis, YM, Hasanin, ME, Felaya, EE, Aldhahi, MI, Abdeen, HAA
European review for medical and pharmacological sciences. 2023;27(9):4069-4079
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Hypertension is considered one of the risk factors for cardiovascular disease. Hypertension is a multifactorial condition in which arterial stiffness is one of its manifestations. Exercise is a nonpharmaceutical intervention, and it is known to induce cardiovascular benefits. The aim of this study was to evaluate if the mechanistic effect of high-intensity interval training (HIIT) would affect arterial stiffness parameters in sedentary obese hypertensive women. This study is a randomised controlled trial which enrolled sixty hypertensive women between the ages of 40 and 50 years. Participants were randomly assigned to one of two groups: 1) 12-week of high-intensity interval training or 2) a control group. Results show that HIIT has a beneficial effect on lowering arterial stiffness in obese hypertensive women. Furthermore, HIIT resulted in significant improvements in several metabolic parameters namely blood pressure, total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, and triglycerides. Authors conclude that HIIT for 12 weeks reduces cardiometabolic risk factors and improves arterial stiffness indices in obese hypertensive women. Thus, HIIT should be included in the treatment of obese hypertensive women to reduce their risk of cardiovascular disease.
Abstract
OBJECTIVE High-intensity interval training (HIIT) has been linked to a lower risk of cardiovascular disease and mortality. The study's overarching goal is to evaluate the impact of HIIT on arterial stiffness in obese hypertensive women. PATIENTS AND METHODS Sixty obese hypertensive women aged between 40-50 years were randomized to group A (Intervention group, n = 30) or group B (Control group, n = 30). Intervention group received HIIT (4 minutes of cycling at 85-90% of peak HR interspersed with 3-minute active recovery time at 60 - 70% of peak HR, three times per week). Arteriovenous stiffness indicators, the augmentation index corrected for heart rate 75 (AIx@75HR), and oscillometric pulse wave velocity (o-PWV), as well as cardio-metabolic parameters, were assessed before and after 12 weeks of treatment. RESULTS Finding between-group analysis showed a significant difference in AIx@75HR (95% CI: -8.45 to 0.30) , o-PWV ( 95% CI: -1.14 to 0.15), total cholesterol, (95% CI: -31.25 to -1.12), HDL-cholesterol (95% CI: 8.92 to 0.94), LDL-cholesterol (95% CI: -25.35 to -0.06) , and triglycerides (95% CI: -53.58 to -2.51). CONCLUSIONS High-intensity interval training for 12 weeks has a favorable effect on arterial stiffness in obese hypertensive women and lowers associated cardio-metabolic risk factors.
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Effects of dietary fibers or probiotics on functional constipation symptoms and roles of gut microbiota: a double-blinded randomized placebo trial.
Lai, H, Li, Y, He, Y, Chen, F, Mi, B, Li, J, Xie, J, Ma, G, Yang, J, Xu, K, et al
Gut microbes. 2023;15(1):2197837
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Functional constipation is characterised by continuously difficult, incomplete, or infrequent defecation, without an organic origin. Effective intervention strategies are required to relieve the functional constipation difficulties, particularly in rapidly aging populations, such as Chinese populations. The aim of this study was to evaluate the effectiveness of three dietary fibre formulas (polydextrose, psyllium husk, and wheat bran + psyllium husk) and one probiotic supplement on the improvement of constipation symptoms among Chinese adults with functional constipation. This study was a double-blinded randomised placebo-controlled trial which enrolled 250 participants who were randomly assigned to one of the five groups. Results showed: - that daily supplement of three prebiotic formulas with dietary fibres, or a probiotic formula effectively relieved hard stool in functional constipation patients after 4 weeks intervention. - the capacity of gut microbial genera in shaping the intervention responsiveness in the improvement of bowel movement frequency, Bristol stool scale score, and degree of defecation straining. Authors conclude that the pre or probiotic interventions may modulate gut microbiota, associated with intestinal health.
Abstract
Dietary fibers/probiotics may relieve constipation via optimizing gut microbiome, yet with limited trial-based evidences. We aimed to evaluate the effects of formulas with dietary fibers or probiotics on functional constipation symptoms, and to identify modulations of gut microbiota of relevance. We conducted a 4-week double-blinded randomized placebo-controlled trial in 250 adults with functional constipation. Intervention: A: polydextrose; B: psyllium husk; C: wheat bran + psyllium husk; D: Bifidobacterium animalis subsp. lactis HN019 + Lacticaseibacillus rhamnosus HN001; Placebo: maltodextrin. Oligosaccharides were also included in group A to D. 16S rRNA sequencing was used to assess the gut microbiota at weeks 0, 2, and 4. A total of 242 participants completed the study. No time-by-group effect was observed for bowel movement frequency (BMF), Bristol stool scale score (BSS), and degree of defecation straining (DDS), while BSS showed mean increases of 0.95-1.05 in group A to D (all P < 0.05), but not significantly changed in placebo (P = 0.170), and 4-week change of BSS showed similarly superior effects of the interventions as compared placebo. Group D showed a marginal reduction in plasma 5-hydroxytryptamine. Group A resulted in a higher Bifidobacterium abundance than placebo at week 2 and 4. Fourteen genera showed intervention-specific increasing or decreasing trends continuously, among which Anaerostipes showed increasing trends in groups B and C, associated with BMF increase. Random forest models identified specific baseline microbial genera panels predicting intervention responders. In conclusion, we found that the dietary fibers or probiotics may relieve hard stool, with intervention-specific changes in gut microbiota relevant to constipation relief. Baseline gut microbiota may predispose the intervention responsiveness. ClincialTrials.gov number, NCT04667884. What is the context?Supplementation of dietary fibers, such as psyllium husk or wheat bran (10 ~ 15 g/day) may relieve constipation symptoms, but bloating and flatulence are major concerns on a high fiber intake.Functional constipation patients had alternated gut microbiota profiles, while meta-analysis suggested that multispecies probiotics may increase bowel movement frequency and relieve hard stool in functional constipation.Dietary fibers or probiotics may lead to before-after changes of gut microbiota in patients with functional constipation, but time-series continued changes of gut microbiota during the intervention are unknown.Elevation of 5-hydroxytryptamine synthesis in enterochromaffin cells may affect bowel movement. And the elevated plasma 5-hydroxytryptamine was observed in functional constipation patients.What is new? Daily supplement of three prebiotic formulas with dietary fibers (polydextrose, psyllium husk, wheat bran, together with oligosaccharides), or a probiotic formula with Bifidobacterium animalis subsp. lactis HN019 + Lacticaseibacillus rhamnosus HN001 effectively relieved hard stool in functional constipation patients after 4 weeks intervention.We identified continued increasing or decreasing gut microbial genera over the intervention. Dietary fiber – gut microbiota (Anaerostipes)—constipation relieve (bowel movement frequency) evidence axis was identified in this human trial.Probiotic supplementation marginally reduced plasma 5-hydroxytryptamine, possibly associated with changes in BMF-related gut microbial genera.Intervention-specific baseline gut microbiota well predicted the responsiveness of constipation symptom relief.What is the impact? We provided references for the dosage and duration of dietary fiber/probiotics recommendations for adults with functional constipation, and advanced the microbial genera evidences of the fibers/probiotics-microbiota-laxation theory in humans.
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Interactions between Mediterranean Diet Supplemented with Dairy Foods and the Gut Microbiota Influence Cardiovascular Health in an Australian Population.
Choo, JM, Murphy, KJ, Wade, AT, Wang, Y, Bracci, EL, Davis, CR, Dyer, KA, Woodman, RJ, Hodgson, JM, Rogers, GB
Nutrients. 2023;15(16)
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Diet is a fundamental determinant of metabolic health and immune regulation. Long-term dietary patterns also play an important role in shaping the intestinal commensal microbiota. The aim of this study was to explore the effects of an-8 week Mediterranean Diet enriched with dairy foods on the gut microbiome of Australian adults at risk of cardiovascular disease. This study was a randomised controlled trial with a 2 × 2 cross-over design. Participants followed a Mediterranean diet with 3–4 daily serves of dairy foods of 1000–1300mg per day (MedDairy) or low-fat diet (LFD) diet intervention for 8 weeks, separated by an 8-week washout phase where participants returned to their habitual diet. Participants (n= 43) were randomly assigned to their first dietary phase. Results showed that compared to the LFD (control), the MedDairy diet did not result in broad changes to the gut microbiota but significantly altered the relative abundance of selected bacterial taxa. Furthermore, microbial changes, including an increase in Butyricicoccus, were inversely correlated with changes in systolic blood pressure. Authors conclude that an 8-week MedDiet supplemented with dairy foods results in relative abundance changes in bacterial taxa.
Abstract
The impact of a Mediterranean diet on the intestinal microbiome has been linked to its health benefits. We aim to evaluate the effects of a Mediterranean diet supplemented with dairy foods on the gut microbiome in Australians at risk of cardiovascular disease. In a randomised controlled cross-over study, 34 adults with a systolic blood pressure ≥120 mmHg and with risk factors for cardiovascular disease were randomly allocated to a Mediterranean diet with 3-4 daily serves of dairy foods (Australian recommended daily intake (RDI) of 1000-1300 mg per day (MedDairy)) or a low-fat (LFD) control diet. Between each 8-week diet, participants underwent an 8-week washout period. Microbiota characteristics of stool samples collected at the start and end of each diet period were determined by 16S rRNA amplicon sequencing. MedDairy-associated effects on bacterial relative abundance were correlated with clinical, anthropometric, and cognitive outcomes. No change in the overall faecal microbial structure or composition was observed with either diet (p > 0.05). The MedDairy diet was associated with changes in the relative abundance of several bacterial taxa, including an increase in Butyricicoccus and a decrease in Colinsella and Veillonella (p < 0.05). Increases in Butyricicoccus relative abundance over 8 weeks were inversely correlated with lower systolic blood pressure (r = -0.38, p = 0.026) and positively correlated with changes in fasting glucose levels (r = 0.39, p = 0.019), specifically for the MedDairy group. No significant associations were observed between the altered taxa and anthropometric or cognitive measures (p > 0.05). Compared to a low-fat control diet, the MedDairy diet resulted in changes in the abundance of specific gut bacteria, which were associated with clinical outcomes in adults at risk of CVD.
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The Effect of Probiotic Supplements on Metabolic Parameters of People with Type 2 Diabetes in Greece-A Randomized, Double-Blind, Placebo-Controlled Study.
Zikou, E, Dovrolis, N, Dimosthenopoulos, C, Gazouli, M, Makrilakis, K
Nutrients. 2023;15(21)
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Type 2 diabetes is a multifaceted disease caused by both genetic and environmental factors such as excessive energy intake and lack of exercise. The gut microbiome has been shown to contribute to many different diseases including diabetes through its effects on the immune system, appetite, and fat storage. Probiotics are living organisms that have health benefits to humans and they have been studied for their effects on individuals with type 2 diabetes. However, the studies that have been performed have shown inconsistent results due to poorly designed trials. This randomised control trial aimed to determine the effects of a probiotic supplement containing Lactobacillus, Bifidobacterium, and Saccharomyces species on measures of blood sugar control over a period of 6 months. The results showed that compared to controls, there were significant reductions in measures of blood sugar and total cholesterol. Interestingly the probiotics did not change the diversity of the subjects gut microbiome but did alter their function noting changes in enzymes and metabolites involved in diabetes. It was concluded that over a 6-month period, the supplementation of probiotics containing Lactobacillus, Bifidobacterium, and Saccharomyces was of benefit to blood sugar balance and cholesterol levels. This study could be used by healthcare professionals to recommend a specific probiotic to individuals with type 2 diabetes.
Abstract
The role of probiotic supplementation in type 2 diabetes (T2D) treatment is controversial. The present study aimed to assess the effects of a multi-strain probiotic supplement (LactoLevureR (containing Lactobacillus acidophilus, Lactobacillus plantarum, Bifidobacterium lactis, and Saccharomyces boulardii)) over 6 months, primarily on glycemic control as well as on lipid levels and alterations in the gut microbiome, among individuals with T2D residing in Greece. A total of 91 adults with T2D (mean age [±SD] 65.12 ± 10.92 years, 62.6% males) were randomized to receive the probiotic supplement or a matching placebo capsule, once daily, for 6 months. Blood chemistries and anthropometric parameters were conducted every 3 months, and stool samples were collected at baseline and at 6 months. Significant reductions in HbA1c, fasting blood glucose, and total cholesterol were observed in participants treated with the probiotic supplement (n = 46) compared to the controls (n = 45), even after adjustment for a greater decrease in adiposity (waist circumference). Although there were no statistically significant differences in the diversity of the gut microbiome (α and β diversity), the administration of probiotics did influence several genera, metabolites, and key enzymes associated with diabetes. Overall, the administration of the multi-strain probiotic LactoLevureR over a 6-month period in individuals with T2D was well-tolerated and had a positive impact on metabolic parameters, alongside improvements in indices of adiposity.
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Effects of Diet on 10-Year Atherosclerotic Cardiovascular Disease Risk (from the DASH Trial).
Jeong, SY, Wee, CC, Kovell, LC, Plante, TB, Miller, ER, Appel, LJ, Mukamal, KJ, Juraschek, SP
The American journal of cardiology. 2023;187:10-17
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Determining the 10-year risk of heart disease can be used as tool to determine appropriate treatment plans. This study of 459 adults aged 22-75 years with obesity aimed to compare the effects on the 10-year risk for the development heart disease of an 8-week dietary approaches to stop hypertension (DASH) diet, with the standard American diet (AD) and a diet high in fruits and vegetables (F/V). The results showed that the DASH diet significantly improved risk factors such as systolic blood pressure and total cholesterol. However, the F/V diet had an improvement in good cholesterol, which the DASH diet did not. This equated to a similar 10% reduction in the 10-year heart disease risk compared to the AD. It was concluded that compared to a typical AD, DASH and F/V diets reduced the risk for heart disease over a 10-year period. However, the actual risk reduction was only small and individuals with obesity may need to reduce their risk further with other therapies. This study could be used by healthcare professionals to recommend a DASH diet or a diet high in fruits and vegetables to reduce the long-term risk for heart disease alongside other proven therapies or methods to reduce risk.
Expert Review
Conflicts of interest:
None
Take Home Message:
- DASH and F/V diets may be of benefit to obese individuals to decrease their risk for ASCVD
- The DASH diet did reduce HDL cholesterol and recommendations should be made to limit this effect (e.g. exercise and more fruit and vegetables in the diet).
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
This study aimed to determine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet compared to a standard American diet (AD) and a diet emphasising fruits and vegetables (F/V) on the 10-year risk of atherosclerotic cardiovascular disease (ASCVD) and how adopting these diets affect specific risk factors (e.g systolic blood pressure (SBP), diastolic blood pressure (DBP) and blood lipids).
Methods
- Secondary analysis from the DASH trial which ran for 8 weeks in 459 adults aged 22-75 years with obesity
- All meals were provided and dietary intake was adjusted to prevent weight loss
- The primary outcome was an absolute and relative difference in 10-year ASCVD risk from baseline.
Participants were randomised to one of three diets:
1) DASH diet
2) F/V diet, similar to AD but with more fruits and vegetables and higher potassium and magnesium
3) Standard AD.
Results
- DASH significantly lowered SBP, total cholesterol, and HDL cholesterol compared to F/V (absolute difference SBP: -2.8, (95% confidence interval [CI]-4.5, -1.2), total cholesterol: 9.3 (-14.7, 3.9), and HDL cholesterol: -3.5 (-5.0, -2.1) P=<0.05 for all)
- DASH significantly lowered SBP, total cholesterol, and HDL cholesterol compared to AD (absolute difference SBP: -5.3 (-7.0, -3.7), total cholesterol: -13.1 (-18.5, -7.7), and HDL cholesterol: -3.8 (-5.2, -2.4) P=<0.05 for all)
- Compared to AD, DASH and F/V diets reduced 10-year ASCVD relative risk by -10.3%
( −14.4 to −5.9) and −9.9% ( −14.0 to −5.5) respectively
- This translated into low actual risk reductions of -0.21% for the F/V diet and -0.17% for the DASH diet
- Although DASH improved SBP, and total cholesterol compared to F/V, no differences in ASCVD risk between DASH and F/V were apparent. This was attributable to the detrimental effect of the DASH diet on HDL cholesterol, which was not seen in the F/V diet
- The effects of the DASH diet were more pronounced in black participants and in women.
Conclusion
Compared to the AD, DASH and F/V reduced 10-year ASCVD risk by approximately 10% over 8-weeks. The DASH diet was more effective for women and black adults.
Clinical practice applications:
- DASH and F/V diets decrease risk factors and an individual’s risk of ASCVD, and should be encouraged in individuals with obesity, especially women and black adults
- However, these diets do still leave obese individuals at risk for ASCVD.
Considerations for future research:
- Research on these diets in combination with weight loss regimes may give more pronounced results
- It may also be interesting to understand the mechanisms behind why the DASH diet reduces HDL cholesterol.
Abstract
Although modern risk estimators, such as the American College of Cardiology/American Heart Association Pooled Cohort Equation, play a central role in the decisions of patients to start pharmacologic therapy to prevent atherosclerotic cardiovascular disease (ASCVD), there is limited evidence to inform expectations for 10-year ASCVD risk reduction from established lifestyle interventions. Using data from the original DASH (Dietary Approaches to Stop Hypertension) trial, we determined the effects of adopting the DASH diet on 10-year ASCVD risk compared with adopting a control or a fruits and vegetables (F/V) diet. The DASH trial included 459 adults aged 22 to 75 years without CVD and not taking antihypertensive or diabetes mellitus medications, who were randomized to controlled feeding of a control diet, an F/V diet, or the DASH diet for 8 weeks. We determined 10-year ASCVD risk with the American College of Cardiology/American Heart Association Pooled Cohort Equation based on blood pressure and lipids measured before and after the 8-week intervention. Compared with the control diet, the DASH and F/V diets changed 10-year ASCVD risk by -10.3% (95% confidence interval [CI] -14.4 to -5.9) and -9.9% (95% CI -14.0 to -5.5) respectively; these effects were more pronounced in women and Black adults. There was no difference between the DASH and F/V diets (-0.4%, 95% CI -6.9 to 6.5). ASCVD reductions attributable to the difference in systolic blood pressure alone were -14.6% (-17.3 to -11.7) with the DASH diet and -7.9% (-10.9 to -4.8) with the F/V diet, a net relative advantage of 7.2% greater relative reduction from DASH compared with F/V. This was offset by the effects on high-density lipoprotein of the DASH diet, which increased 10-year ASCVD by 8.8% (5.5 to 12.3) compared with the more neutral effect of the F/V diet of -1.9% (-5.0 to 1.2). In conclusion, compared with a typical American diet, the DASH and F/V diets reduced 10-year ASCVD risk scores by about 10% over 8 weeks. These findings are informative for counseling patients on both choices of diet and expectations for 10-year ASCVD risk reduction.
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Ameliorating effects of L-carnitine and synbiotic co-supplementation on anthropometric measures and cardiometabolic traits in women with obesity: a randomized controlled clinical trial.
Fallah, F, Mahdavi, R
Frontiers in endocrinology. 2023;14:1237882
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Obesity is a multifactorial relapsing chronic disease attributed to the complicated interaction of behavioural, environmental, and genetic factors. Given the adverse effects of anti-obesity medications, there has been a great appeal in the consumption of weight loss supplements among individuals suffering from obesity seeking a “magic bullet,” which is less demanding than conventional weight management protocols. The aim of this study was to assess the effects of concomitant supplementation of L-carnitine and a multistrain/multispecies synbiotic compared with L-carnitine single therapy on the anthropometric and cardiometabolic indices in healthy women with obesity. This study was a double-blind, controlled, randomised clinical trial. Following a 2-week run-in period, the participants were randomly allocated to the “L-carnitine + synbiotic” or “L-carnitine + placebo” groups (1:1 ratio). Results showed that supplementation of multistrain/multispecies synbiotic (250 mg/day) concomitant with L-carnitine (2 × 500 mg/day) for 8 weeks led to greater amendments in anthropometric and glycaemic indices, and high-density lipoprotein cholesterol in healthy female individuals with obesity without any severe side effects. Authors concluded that co-administration of L-carnitine and synbiotic may be an encouraging therapeutic strategy for obesity and related cardiometabolic complications.
Abstract
BACKGROUND Obesity, a multifactorial disorder with pandemic dimensions, is conceded a major culprit of morbidity and mortality worldwide, necessitating efficient therapeutic strategies. Nutraceuticals and functional foods are considered promising adjuvant/complementary approaches for weight management in individuals with obesity who have low adherence to conventional treatments. Current literature supports the weight-reducing efficacy of pro/pre/synbiotics or L-carnitine; however, the superiority of the nutraceutical joint supplementation approach over common single therapies to counter obesity and accompanying comorbidities is well documented. This study was designed to assess the effects of L-carnitine single therapy compared with L-carnitine and multistrain/multispecies synbiotic co-supplementation on anthropometric and cardiometabolic indicators in women with obesity. METHODS The current placebo-controlled double-blind randomized clinical trial was performed on 46 women with obesity, randomly allocated to either concomitant supplementation [L-carnitine tartrate (2 × 500 mg/day) + multistrain/multispecies synbiotic (1 capsule/day)] or monotherapy [L-carnitine tartrate (2 × 500 mg/day) + maltodextrin (1 capsule/day)] groups for 8 weeks. Participants in both groups received healthy eating dietary advice. RESULTS Anthropometric, lipid, and glycemic indices significantly improved in both intervention groups; however, L-carnitine + synbiotic co-administration elicited a greater reduction in the anthropometric measures including body mass index (BMI), body weight, and neck, waist, and hip circumferences (p < 0.001, <0.001, <0.001, = 0.012, and =0.030, respectively) after adjusting for probable confounders. Moreover, L-carnitine + synbiotic joint supplementation resulted in a greater reduction in fasting blood sugar (FBS), insulin (though marginal), and homeostatic model assessment of insulin resistance (HOMA-IR) and more increment in quantitative insulin sensitivity check index (QUICKI; p = 0.014, 0.051, 0.024, and 0.019, respectively) compared with the L-carnitine + placebo monosupplementation. No significant intergroup changes were found for the lipid profile biomarkers, except for a greater increase in high-density lipoprotein-cholesterol concentrations (HDL-C) in the L-carnitine + synbiotic group (p = 0.009). CONCLUSION L-carnitine + synbiotic co-supplementation was more beneficial in ameliorating anthropometric indices as well as some cardiometabolic parameters compared with L-carnitine single therapy, suggesting that it is a promising adjuvant approach to ameliorate obesity or associated metabolic complications through potential synergistic or complementary mechanisms. Further longer duration clinical trials in a three-group design are demanded to verify the complementary or synergistic mechanisms. CLINICAL TRIAL REGISTRATION www.irct.ir, Iranian Registry of Clinical Trials IRCT20080904001197N13.
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Cardiometabolic Effects of Omnivorous vs Vegan Diets in Identical Twins: A Randomized Clinical Trial.
Landry, MJ, Ward, CP, Cunanan, KM, Durand, LR, Perelman, D, Robinson, JL, Hennings, T, Koh, L, Dant, C, Zeitlin, A, et al
JAMA network open. 2023;6(11):e2344457
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Plain language summary
A vegan dietary pattern is typically lower in energy density but higher in fibre, vitamins, minerals, and phytonutrients compared with other dietary patterns. However, sometimes a vegan dietary pattern can limit specific nutrients, such as vitamin B12, iron, and calcium. In addition, a poorly formulated vegan diet can include low-quality plant foods, such as refined carbohydrates and added sugars. The aim of this study was to compare the cardiometabolic effects of a healthy vegan diet with a healthy omnivorous diet, exposing both groups to vegetables, legumes, fruits, whole grains, nuts, and seeds. This study was a single-site, parallel-group, dietary intervention randomised clinical trial which randomised healthy, adult identical twins to a healthy vegan or omnivorous diet for 8 weeks. Results showed that: - low-density lipoprotein was significantly lower for twins receiving the vegan diet compared with twins receiving the omnivorous diet. - insulin levels and weight were also significantly lower among the twins on the vegan diet from baseline to 8 weeks. - vegan-diet participants had total lower protein intake as a percentage of calories, lower dietary satisfaction, lower intake of dietary cholesterol, but higher intake of vegetable servings and intake of dietary iron. - vegans had lower intake of vitamin B12, yet serum vitamin B12 levels were not statistically different than omnivores at 8 weeks. Authors concluded that their findings show cardiometabolic advantages for the healthy vegan vs the healthy omnivorous diet among healthy, adult identical twins. Thus, clinicians may consider recommending plant-based diets to reduce cardiometabolic risk factors, as well as aligning with environmental benefits.
Abstract
IMPORTANCE Increasing evidence suggests that, compared with an omnivorous diet, a vegan diet confers potential cardiovascular benefits from improved diet quality (ie, higher consumption of vegetables, legumes, fruits, whole grains, nuts, and seeds). OBJECTIVE To compare the effects of a healthy vegan vs healthy omnivorous diet on cardiometabolic measures during an 8-week intervention. DESIGN, SETTING, AND PARTICIPANTS This single-center, population-based randomized clinical trial of 22 pairs of twins (N = 44) randomized participants to a vegan or omnivorous diet (1 twin per diet). Participant enrollment began March 28, 2022, and continued through May 5, 2022. The date of final follow-up data collection was July 20, 2022. This 8-week, open-label, parallel, dietary randomized clinical trial compared the health impact of a vegan diet vs an omnivorous diet in identical twins. Primary analysis included all available data. INTERVENTION Twin pairs were randomized to follow a healthy vegan diet or a healthy omnivorous diet for 8 weeks. Diet-specific meals were provided via a meal delivery service from baseline through week 4, and from weeks 5 to 8 participants prepared their own diet-appropriate meals and snacks. MAIN OUTCOMES AND MEASURES The primary outcome was difference in low-density lipoprotein cholesterol concentration from baseline to end point (week 8). Secondary outcome measures were changes in cardiometabolic factors (plasma lipids, glucose, and insulin levels and serum trimethylamine N-oxide level), plasma vitamin B12 level, and body weight. Exploratory measures were adherence to study diets, ease or difficulty in following the diets, participant energy levels, and sense of well-being. RESULTS A total of 22 pairs (N = 44) of twins (34 [77.3%] female; mean [SD] age, 39.6 [12.7] years; mean [SD] body mass index, 25.9 [4.7]) were enrolled in the study. After 8 weeks, compared with twins randomized to an omnivorous diet, the twins randomized to the vegan diet experienced significant mean (SD) decreases in low-density lipoprotein cholesterol concentration (-13.9 [5.8] mg/dL; 95% CI, -25.3 to -2.4 mg/dL), fasting insulin level (-2.9 [1.3] μIU/mL; 95% CI, -5.3 to -0.4 μIU/mL), and body weight (-1.9 [0.7] kg; 95% CI, -3.3 to -0.6 kg). CONCLUSIONS AND RELEVANCE In this randomized clinical trial of the cardiometabolic effects of omnivorous vs vegan diets in identical twins, the healthy vegan diet led to improved cardiometabolic outcomes compared with a healthy omnivorous diet. Clinicians can consider this dietary approach as a healthy alternative for their patients. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT05297825.