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The Effects of Low-Energy Moderate-Carbohydrate (MCD) and Mixed (MixD) Diets on Serum Lipid Profiles and Body Composition in Middle-Aged Men: A Randomized Controlled Parallel-Group Clinical Trial.
Michalczyk, MM, Maszczyk, A, Stastny, P
International journal of environmental research and public health. 2020;17(4)
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Diets high in poor quality carbohydrates and fats and low in fibre are believed to play an integral role in the formation of many different chronic diseases. Calorie restricted diets have previously shown to have health benefits, but these are stringent and hard to maintain. More recently low-carbohydrate diets have shown that they may be better tolerated. This randomised control trial aimed to compare a calorie restricted diet (MixD) with a calorie restricted moderate-carbohydrate diet (MCD) on indicators for chronic disease in 60 overweight and obese men over four weeks. The results showed that MCD resulted in significant loss of body fat without loss of muscle mass compared to MixD and significantly decreased markers for heart disease risk. It was concluded that the amount of body fat can be attributed to the amount and quality of carbohydrates consumed and that consumption of a MCD is more effective for weight loss without compromising muscle mass than a MixD. This study could be used by health professionals to recommend a MCD to middle aged obese men in order to lose body fat, retain muscle mass and reduce their risk of heart disease.
Abstract
Carbohydrate-restricted diets have become very popular due to their numerous health benefits. The aim of this study was to determine the influence of 4 weeks of a well-planned, low-energy moderate-carbohydrate diet (MCD) and a low-energy mixed diet (MixD) on the lipoprotein profile, glucose and C-reactive protein concentrations, body mass, and body composition in middle-aged males. Sixty middle-aged males were randomly assigned to the following groups: hypocaloric MCD (32% carbohydrates, 28% proteins, and 40% fat), hypocaloric MixD (50% carbohydrates, 20% proteins, and 30% fat), and a conventional (control) diet (CD; 48% carbohydrates, 15% proteins, and 37% fat). The participants who were classified into the MCD and MixD groups consumed 20% fewer calories daily than the total daily energy expenditure (TDEE). Baseline and postintervention fasting triacylglycerol (TG), LDL (low-density lipoprotein) cholesterol (LDL-C), HDL (high-density lipoprotein) cholesterol (HDL-C), total cholesterol (tCh), glucose (Gl), and C-reactive protein were evaluated. Body mass (BM) and body composition changes, including body fat (BF), % body fat (PBF), and muscle mass (MM), were monitored. Compared with MixD and CD, MCD significantly changed the fasting serum concentrations of TG (p < 0.05), HDL-C (p < 0.05), LDL-C (p < 0.05), tCh (p < 0.05), and glucose (p < 0.01). Additionally, body fat content (kg and %) was significantly reduced (p < 0.05) after MCD compared with MixD and CD. After the MixD intervention, BM and MM decreased (p < 0.05) compared with baseline values. Compared with baseline, after the MixD, BM, MM, tCh, LDL-C, and TG changed significantly. The 4 week low-energy MCD intervention changed lipoproteins, glucose, and body fat to a greater extent than the low-energy MixD. A hypocaloric MCD may be suggested for middle-aged male subjects who want to lose weight by reducing body fat content without compromising muscle mass.
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Effect of 12-Week Interventions Involving Nordic Walking Exercise and a Modified Diet on the Anthropometric Parameters and Blood Lipid Profiles in Overweight and Obese Ex-Coal Miners.
Sadowska-Krępa, E, Gdańska, A, Rozpara, M, Pilch, W, Přidalová, M, Bańkowski, S
Obesity facts. 2020;13(2):201-212
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Upon retirement, underground coal miners who previously expended a lot of energy in their work, do not change their eating habits, resulting in weight gain. Increasing moderate intensity physical activity and adjusting the diet may combat this. However, introduction at the same time may be difficult and demotivating for some individuals. This 12-week intervention study aimed to assess the effect of Nordic walking (NW) or a reduced calorie diet on 30 overweight and obese coal miners. The results showed that both low calorie diet and NW improved body measurements, however low-calorie diet was more successful. NW did improve indicators of lower cardiovascular disease risk compared to low-calorie diet, but this was not sustained. It was concluded that although both treatments were effective in improving body measurements and fats, calorie restriction was more effective. This study could be used by physicians to recommend a calorie restricted diet to overweight and obese individuals; however, the combined effect of diet and exercise should not be underestimated, and exercise should be considered after successful introduction of a modified diet.
Abstract
BACKGROUND Overweight and obesity after retirement are likely to be caused by unhealthy eating habits and the energy intake exceeding the energy expenditure. OBJECTIVES This study was designed to assess the effects of two 12-week interventions involving, respectively, either regular physical activity or a modified lower-calorie diet on the anthropometric parameters and blood lipid profiles in overweight and obese retired miners with lipid disorders. DESIGN The study participants (n = 30, aged 58.7 ± 4.1 years, body height 174.8 ± 7.3 cm, body weight 96.6 ± 13.9 kg) were randomly assigned to 2 intervention groups: the Nordic walking group (NW), which exercised with intensity from 60 to 70% of participants' maximal heart rates for 1 h 3 times a week, and the modified diet group (MD). Modification of the diet consisted of reducing the daily energy intake by 30%, increasing the dietary content of mono- and polyunsaturated fatty acids and dietary fiber, and reducing the proportion of saturated fatty acids. The variables assessed at baseline and after 6 and 12 weeks were: anthropometric parameters (body weight, fat mass content [FM], fat percentage [BF], BMI, waist circumference [WC], hip circumference [HC], and waist-to-hip ratio [WHR]) and blood lipid indicators (total cholesterol [TC], triglycerides [TG], low density lipoprotein cholesterol [LDL-C], and high density lip-oprotein cholesterol [HDL-C]). RESULTS The body weight of the participants in the NW was lower at week 12 by an average of 5 kg, BMI by 6%, FB by 19%, FM by 15%, WC by 8%, HC by 6%, and WHR by 3%. In the MD, the respective decreases were 8 kg and 8, 25, 20, 6, 2, and 7%. In the MD, the postintervention concentrations of TC and TG were within the reference range. CONCLUSION Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.
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Effects of high-intensity interval and moderate-intensity continuous aerobic exercise on diabetic obese patients with nonalcoholic fatty liver disease: A comparative randomized controlled trial.
Abdelbasset, WK, Tantawy, SA, Kamel, DM, Alqahtani, BA, Elnegamy, TE, Soliman, GS, Ibrahim, AA
Medicine. 2020;99(10):e19471
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Non-alcoholic fatty liver disease (NAFLD) is a condition linked to obesity and is characterised by high amounts of fat in the liver. This can lead to a high rate of mortality, but it can be improved by diet and exercise. It is unclear as to the best form of exercise for the improvement of NAFLD. This randomised control trial aimed to assess the effects of high-intensity interval exercise (HII) versus moderate-intensity exercise on liver fat content in 47 diabetic obese patients with NAFLD over 8 weeks. The results showed that regardless of exercise treatment, both improved measures of NAFLD and there were no differences between the two groups. Interestingly blood sugar control was also improved with both exercise treatments. It was concluded that both exercise regimes improved contributors to NAFLD, with no differences between the two treatments. This study would be useful to health professionals when recommending exercise to diabetic obese patients especially those with NAFLD, giving them the option of HII or MIC to improve their condition.
Abstract
BACKGROUND Some studies assessed the effect of aerobic exercise on diabetic obese patients with hepatic disease, while very limited studies compared high-intensity interval (HII) versus moderate-intensity continuous (MIC) on diabetic obese patients with non-alcoholic fatty liver disease (NAFLD). OBJECTIVES This study was designed to assess the effects of HII versus MIC on intrahepatic triglycerides (IHTG) and visceral lipids in diabetic obese patients with NAFLD. DESIGN Randomized controlled trial. METHODS Forty-seven diabetic obese individuals with NAFLD were enrolled in this study. The individuals were randomly divided into 16 in HII group, 15 in MIC group, and 16 in the controls. HII group received HII exercise, MIC group received 8-week MIC exercise while the control group did not receive any exercise intervention. IHTG and visceral lipids were assessed pre- and post-intervention. RESULTS Baseline and clinical characteristics showed nonsignificant difference among the 3 groups (P > .05). Both HII and MIC groups showed a significant reduction in hepatic fat and visceral lipids (P < .05), while the controls showed nonsignificant difference (P > .05) after completing the study intervention. Postintervention analysis showed nonsignificant changes between the HII and MIC groups (P > .05). CONCLUSIONS Exercise training wither HII or MIC aerobic exercise reduces IHGT and visceral lipids in diabetic obese patients with NAFLD. No differences were observed between the effects of both exercise programs on diabetic obese patients with NAFLD.
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The Weight Optimization Revamping Lifestyle using the Dietary Guidelines (WORLD) Study: Sustained Weight Loss Over 12 Months.
Psota, TL, Tindall, AM, Lohse, B, Miller, PE, Petersen, KS, Kris-Etherton, PM
Obesity (Silver Spring, Md.). 2020;28(7):1235-1244
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Effective long-term weight loss strategies to reduce the risk of death and diseases associated with being obese or overweight are required, as restrictive programmes are difficult to sustain, and weight loss may be heavily influenced by behavioural factors. This randomised control trial of 101 premenopausal women with obesity or overweight aimed to compare a lower-fat and moderate-fat diets, both with nutrition education for 12 months. The results showed that both treatment groups lost weight. Both groups consumed the same amount of fat but increased their diet quality. Diet quality and greater attendance at nutritional education sessions were associated with greater weight loss. Cholesterol was significantly lower in both groups, but blood pressure remained unchanged. Interestingly there were a large number of women who did not complete the trial. It was concluded that irrespective of the amount of fat consumed, nutrition education can help to achieve sustained weight loss, improve diet quality and decrease heart disease risk for at least 12 months. This study could be used by healthcare professionals to understand that recommending fat-based targets for weight loss may be ineffective and the importance of emotional and behavioural support for individuals on a weight loss regime to improve their risk for heart disease.
Abstract
OBJECTIVE This study aimed to compare two energy-restricted, nutrient-dense diets at the upper or lower ends of the dietary fat recommendation range (lower fat [20% energy from fat] versus moderate fat [35%]) on weight loss using behavioral theory-based nutrition education. METHODS A total of 101 premenopausal women with overweight or obesity were randomized to an energy-restricted lower-fat or moderate-fat diet for 1 year. Interventions included 28 behavioral theory-based nutrition education sessions plus weekly exercise sessions. RESULTS Both treatment groups experienced weight loss (-5.0 kg for lower fat and -4.3 kg for moderate fat; P < 0.0001), but there was no difference in weight loss or fat intake between groups. Total and low-density lipoprotein cholesterol decreased (-3. 4 mg/dL and -3.8 mg/dL; P < 0.05), and high-density lipoprotein cholesterol increased (1.9 mg/dL; P < 0.05) in both groups at 12 months. Diet quality, assessed by the Healthy Eating Index, increased significantly at 4 months versus baseline (70.8 [0.9] vs. 77.8 [1.0]) and was maintained through 12 months. Higher Healthy Eating Index scores were associated with greater weight loss at 4 months (r = -0.2; P < 0.05). CONCLUSIONS In the context of a well-resourced, free-living weight-loss intervention, total fat intake did not change; however, theory-based nutrition education underpinned by food-based recommendations resulted in caloric deficits, improvements in diet quality, and weight loss that was sustained for 1 year.
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Type 2 Diabetes Mellitus in Class II and III Obesity: Prevalence, Associated Factors, and Correlation between Glycemic Parameters and Body Mass Index.
Silveira, EA, de Souza Rosa, LP, de Carvalho Santos, ASEA, de Souza Cardoso, CK, Noll, M
International journal of environmental research and public health. 2020;17(11)
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Type 2 diabetes mellitus (T2DM) and obesity are independently known to cause serious health complications, with risks of cardiovascular diseases, higher mortality, low quality of life, and increased public health spending. However, when these diseases occur concurrently, their negative effects on health, health systems, and mortality are even greater. The main aim this study was to investigate the prevalence of T2DM and its associated factors, with an emphasis on biochemical parameters and eating habits, in class II and III obese individuals. The study included 150 class II and III obese individuals from the primary healthcare system of the Brazilian Unified Health System. Results indicate a high prevalence of T2DM (40%) in the studied population, with the associated risks being lower educational level, non-consumption of whole grains, and high insulin resistance. Furthermore, there was no correlation between BMI and glycaemic parameters, that is, an increased BMI did not directly affect a decline in the metabolic condition of T2DM individuals. Authors conclude by emphasising the need to perform further research on T2DM in class II and III obese population.
Abstract
Despite the worldwide growth of class II and III obesity, the factors associated with type 2 diabetes mellitus (T2DM) in these obese individuals are not widely understood. Moreover, no study has investigated these associations in South America. Our study aimed to investigate the prevalence of T2DM and its associated factors, with an emphasis on biochemical parameters and eating habits, in class II and III obese individuals. We also aimed to analyze the correlation between glycemic parameters and body mass index (BMI). Baseline data from a randomized clinical trial (DieTBra Trial) of 150 class II and III obese individuals (BMI > 35 kg/m2) was used. An accelerometer, Food Frequency Questionnaire, and bioimpedance analysis were used to assess physical activity levels, eating habits, and body composition, respectively. Blood was collected after 12 h of fasting. Hierarchical multivariate Poisson regression was performed, and prevalence ratios (PRs) were calculated. Correlations between glycemic parameters (fasting blood glucose, glycosylated hemoglobin, homeostasis model assessment of insulin resistance (HOMA-IR), and insulin) and BMI were also analyzed. The prevalence of T2DM was 40.0% (95% CI, 32.1-48.3), high fasting blood glucose level was 19.33% (95% CI, 13.3-26.6), and high glycosylated hemoglobin was 32.67% (95% CI, 25.2-40.8). Age ≥ 50 years (PR = 3.17, 95% CI, 1.26-7.98) was significantly associated with T2DM; there was a positive linear trend between age and T2DM (p = 0.011). Multivariate analysis showed an association with educational level (PR = 1.49, 1.07-2.09, p = 0.018), nonconsumption of whole grains daily (PR = 1.67, 1.00-2.80, p = 0.049), and high HOMA-IR (PR = 1.54, 1.08-2.18, p = 0.016). We found a high prevalence of T2DM and no significant correlations between BMI and glycemic parameters.
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Honey does not adversely impact blood lipids of adult men and women: a randomized cross-over trial.
Al-Tamimi, AM, Petrisko, M, Hong, MY, Rezende, L, Clayton, ZS, Kern, M
Nutrition research (New York, N.Y.). 2020;74:87-95
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Restriction of sugar intake is among the most commonly advocated public health strategies, as it is believed to prevent the development of chronic diseases. Unlike sugar, honey has been shown to have various positive health benefits from increasing antioxidant status to lowering postprandial [after a meal] glycaemia and insulinaemia in healthy subjects when compared to responses of more highly refined sugar mixtures. The aim of this study was to assess responses to both short-term (1 week) and relatively long-term (1 month) ingestion of clover honey consumption versus sucrose on changes in dietary intake and serum lipid concentrations in young to middle-aged adults. This study is a crossover design randomised controlled study for which 40 participants were recruited (male [n = 21] and female [n = 19]) with an age range between 25 and 57 years. Results indicate that consumption of clover honey (1.2 g of carbohydrate per kilogram body weight) for up to 1 month produced modestly positive dietary and triglyceride effects compared to sucrose. - there were no positive lipid effects within the clover honey trial. - compared to sucrose, clover honey consumption resulted in a significantly lower intake of energy, carbohydrate, sugars and fat as well as lower triglycerides concentrations at the end of 4 weeks. Authors conclude that honey produces limited, modest health benefits relative to sucrose. Future studies are needed to investigate the possible mechanisms by which honey influences triglyceride production and/or clearance and the metabolic and hormonal regulators of food intake.
Abstract
Consumption of added sugars in the US is estimated to be approximately 1.5 times recommended levels and has been linked to increased risk for developing chronic diseases. We hypothesized that relative to sugar, honey would reduce energy intake and improve serum lipid profiles. To test this, we assessed the short-term (1-week) and relatively long-term (1-month) effects of honey versus sucrose on changes in dietary intake and serum lipid concentrations. Thirty-seven apparently healthy subjects (21 males; 16 females) aged 24-57 years (BMI = 17.6-37.2 kg/m2) completed two 4-week trials in a randomized, cross-over design separated by ≥4-week washout. During each trial, subjects consumed either clover honey or sucrose providing 1.2 g/kg/day of carbohydrate under free-living conditions with instructions to avoid changing their habitual food intake. Serum triglyceride (TG) concentrations were elevated (P < .05) after 1 week for both trials but only remained elevated (P < .05) at the 4-week time-point during sucrose consumption. The elevation after 1 week during the honey trial was concurrent with a transient increase (P < .05) in body weight. No effects on serum concentrations of insulin, total cholesterol, low density lipoprotein-cholesterol, or high density lipoprotein-cholesterol were detected for either trial. Subjects consumed significantly less energy (P < .05), carbohydrate (P < .005), sugars (P < .05), and saturated fat (P < .05) during the honey trial. These data suggest that honey may serve as a favorable substitute for sucrose with regard to reduced energy intake, carbohydrate and sugars, without negatively influencing serum lipid concentrations.
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Atherogenic Index Reduction and Weight Loss in Metabolic Syndrome Patients Treated with A Novel Pectin-Enriched Formulation of Bergamot Polyphenols.
Capomolla, AS, Janda, E, Paone, S, Parafati, M, Sawicki, T, Mollace, R, Ragusa, S, Mollace, V
Nutrients. 2019;11(6)
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Metabolic syndrome (MetS) is a cluster of several cardiometabolic risk factors, including hyperglycaemia [high levels of blood glucose] or glucose intolerance, high levels of triglycerides and low-density lipoprotein cholesterol and low levels of high-density lipoprotein cholesterol, hypertension, abdominal adiposity and obesity. The purpose of this small-scale clinical trial was to evaluate the effect of bergamot juice extract on MetS patients with moderate hyperglycemia. The study is a randomised, double-blind, placebo-controlled trial which enrolled MetS patients (n=52) aged between 40 to 80 years. Participants were assigned to one of the two treatment groups, or a matched placebo group for a period of 90 days. Results indicate a significant amelioration of dyslipidaemia [abnormal blood lipid levels] and insulin sensitivity in MetS patients after bergamot polyphenol extract complex supplementation. Another important finding is the dose-dependent reduction of body weight and BMI by 10% to 16% in patients receiving low and high dose of bergamot polyphenol extract complex supplementation. Authors conclude that bergamot juice-derived food supplements enriched with pectins and vitamin C, significantly stimulate weight loss, improve insulin sensitivity and reduce circulating insulin, leptin, and ghrelin levels, while increasing significantly the levels of cardioprotective adiponectin.
Abstract
: Bergamot flavonoids counteract dyslipidemia and hyperglycemia but fail to induce a significant weight loss. Here, we evaluated the efficacy of bergamot polyphenol extract complex (BPE-C), a novel bergamot juice-derived formulation enriched with flavonoids and pectins, on several metabolic syndrome parameters. Obese patients with atherogenic index of plasma (AIP) over 0.34 and mild hyperglycemia were recruited to a double-blind randomized trial comparing two doses of BPE-C (650 and 1300 mg daily) with placebo. Fifty-two subjects met the inclusion criteria and were assigned to three experimental groups. Fifteen subjects per group completed 90 days-trial. BPE-C reduced significantly fasting glucose by 18.1%, triglycerides by 32% and cholesterol parameters by up to 41.4%, leading to a powerful reduction of AIP (below 0.2) in the high dose group. The homeostasis model assessment of insulin resistance (HOMA-IR) and insulin levels were also reduced. Moreover, BPE-C decreased body weight by 14.8% and body mass index by 15.9% in BPE-C high group. This correlated with a significant reduction of circulating hormones balancing caloric intake, including leptin, ghrelin and upregulation of adiponectin. All effects showed a dose-dependent tendency. This study suggests that food supplements, containing full spectrum of bergamot juice components, such as BPE-C efficiently induce a combination of weight loss and insulin sensitivity effects together with a robust reduction of atherosclerosis risk.
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Efficacy and Safety of Oral Administration of a Mixture of Probiotic Strains in Patients with Psoriasis: A Randomized Controlled Clinical Trial.
Navarro-López, V, Martínez-Andrés, A, Ramírez-Boscá, A, Ruzafa-Costas, B, Núñez-Delegido, E, Carrión-Gutiérrez, MA, Prieto-Merino, D, Codoñer-Cortés, F, Ramón-Vidal, D, Genovés-Martínez, S, et al
Acta dermato-venereologica. 2019;99(12):1078-1084
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Psoriasis is as an immune-mediated, inflammatory dermatological disease characterized by a chronic-relapsing course and associated with multifactorial inheritance. The elevation of inflammatory markers is characteristic in peripheral blood of patients with psoriasis. The aim of this study was to determine the efficacy and safety of a probiotic mixture in the reduction of psoriasis severity. This study is a double-blind, randomised (1:1) placebo-controlled trial. Ninety patients were recruited, evaluated by 3 dermatologists and randomly assigned to one of the two trial arms (probiotics or control). Results show: - a beneficial effect of the probiotic blend, in reducing the severity of psoriasis when administered as coadjutant therapy together with topical corticosteroid. - the efficacy of the probiotic in modulation of the composition of the microbiota. - that patients previously treated with the probiotic mixture have a lower risk of relapse than those who previously received placebo. Authors conclude that more studies are required with the inclusion of patients younger than 18 years, the use of different doses of probiotics, different durations of probiotic administration and different strains, for comparison with the current results.
Abstract
The aim of this 12-week randomized, double-blind, placebo-controlled trial was to determine the efficacy and safety of a probiotic mixture in the reduction of psoriasis severity. Ninety 18-70-year-old adults with plaque psoriasis were randomized into probiotic and placebo groups. At 12-week follow-up, 66.7% of patients in the probiotic group and 41.9% in the placebo group showed a reduction in Psoriasis Area and Severity Index of up to 75% (p < 0.05). A clinically relevant difference was observed in Physician Global Assessment index: 48.9% in the probiotic group achieved a score of 0 or 1, compared with 30.2% in the placebo group. The results of follow-up 6 months after the end of the study showed a lower risk of relapse after the intake of the probiotic mixture. Analysis of gut microbiota confirmed the efficacy of the probiotic in modulation of the microbiota composition.
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A randomized, double blind, placebo controlled, multicenter clinical trial to assess the efficacy and safety of Emblica officinalis extract in patients with dyslipidemia.
Upadya, H, Prabhu, S, Prasad, A, Subramanian, D, Gupta, S, Goel, A
BMC complementary and alternative medicine. 2019;19(1):27
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Emblica officinalis (Amla or Indian gooseberry) is a fruit that has been traditionally used in Ayurvedic medicine. It has been shown to be effective in the management of dyslipidemia (abnormal fat metabolism), a risk factor for heart disease, in animal models and in pilot clinical studies without major side effects. This multicenter, randomised, placebo controlled, double blind clinical trial was designed to evaluate the efficacy and safety of a proprietary full spectrum amla extract (containing pulp and seeds) in patients with dyslipidemia. 98 patients were enrolled and all completed the 12 week study. None of them were taking any medication for their dyslipidaemia. All the patients enrolled in the study were also asked to initiate lifestyle changes (healthy diet with exercise at least 4 days a week). Apart from conventional lipid parameters, the investigators also measured a number of other parameters relevant to heart disease, including the atherogenic index of plasma (AIP, a marker of heart disease risk). Compared to the placebo group the amla group had significantly greater reductions in triglycerides, LDL-cholesterol, VLDL-cholesterol and the atherogenic index of plasma (AIP, a better predictor of heart disease risk). There were no significant changes in HDL-cholesterol, CoQ10 (lowering of CoQ10 is a concern with many cholesterol lowering drugs), homocysteine, thyroid stimulating hormone (TSH) or fasting blood glucose. Four non-serious adverse events were observed: mild headache, mild fever, two times gastritis (all resolved with standard treatment), three were in the placebo group, one in the amla group. There were no changes in routine blood tests and vital signs (blood pressure, heart rate, temperature, respiratory rate). The authors conclude that the amla extract has significant potential to improve dyslipidaemia without side effects commonly seen with cholesterol lowering drugs.
Abstract
BACKGROUND Dyslipidemia is one of the most frequently implicated risk factors for development of atherosclerosis. This study evaluated the efficacy of amla (Emblica officinalis) extract (composed of polyphenols, triterpenoids, oils etc. as found in the fresh wild amla fruit) in patients with dyslipidemia. METHODS A total of 98 dyslipidemic patients were enrolled and divided into amla and placebo groups. Amla extract (500 mg) or a matching placebo capsule was administered twice daily for 12 weeks to the respective group of patients. The patients were followed up for 12 weeks and efficacy of study medication was assessed by analyzing lipid profile. Other parameters evaluated were apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), Coenzyme Q10 (CoQ10), high-sensitive C-reactive protein (hsCRP), fasting blood sugar (FBS), homocysteine and thyroid stimulating hormone (TSH). RESULTS In 12 weeks, the major lipids such as total cholesterol (TC) (p = 0.0003), triglyceride (TG) (p = 0.0003), low density lipoprotein cholesterol (LDL-C) (p = 0.0064) and very low density lipoprotein cholesterol (VLDL-C) (p = 0.0001) were significantly lower in amla group as compared to placebo group. Additionally, a 39% reduction in atherogenic index of the plasma (AIP) (p = 0.0177) was also noted in amla group. The ratio of Apo B to Apo A1 was reduced more (p = 0.0866) in the amla group as compared to the placebo. There was no significant change in CoQ10 level of amla (p = 0.2942) or placebo groups (p = 0.6744). Although there was a general trend of FBS reduction, the numbers of participants who may be classified as pre-diabetes and diabetes groups (FBS > 100 mg/dl) in the amla group were only 8. These results show that the amla extract used in the study is potentially a hypoglycaemic as well. However, this needs reconfirmation in a larger study. CONCLUSIONS The Amla extract has shown significant potential in reducing TC and TG levels as well as lipid ratios, AIP and apoB/apo A-I in dyslipidemic persons and thus has scope to treat general as well as diabetic dyslipidemia. A single agent to reduce cholesterol as well as TG is rare. Cholesterol reduction is achieved without concomitant reduction of Co Q10, in contrast to what is observed with statins. TRIAL REGISTRATION Registered with Clinical Trials Registry- India at www.ctri.nic.in (Registration number: CTRI/2015/04/005682 ) on 8 April 2015 (retrospectively registered).
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The Obemat2.0 Study: A Clinical Trial of a Motivational Intervention for Childhood Obesity Treatment.
Luque, V, Feliu, A, Escribano, J, Ferré, N, Flores, G, Monné, R, Gutiérrez-Marín, D, Guillen, N, Muñoz-Hernando, J, Zaragoza-Jordana, M, et al
Nutrients. 2019;11(2)
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Multicomponent interventions consisting of dietary modification, physical activity, behavioural therapy, and education have shown to improve body mass index, blood pressure, and lipids profile. The Obemat2.0 trail was designed and conducted to implement and to test the efficacy of a structured multicomponent motivational therapy to treat childhood obesity. The study is a randomised clustered clinical trial with a treatment on children with obesity lasting 12 months. The study had two arms: a control group and an intervention group. The recruitment started in June 2016 and the fieldwork is expected to end in June 2019. The study results will show whether a multicomponent program, including a bundle of motivational strategies conducted in primary centres by therapists with 12h of specific training could be more effective than usual care. Authors expect this clinical trial to open a window of opportunity to support professionals at the primary care level to treat childhood obesity.
Abstract
The primary aim of the Obemat2.0 trial was to evaluate the efficacy of a multicomponent motivational program for the treatment of childhood obesity, coordinated between primary care and hospital specialized services, compared to the usual intervention performed in primary care. This was a cluster randomized clinical trial conducted in Spain, with two intervention arms: motivational intervention group vs. usual care group (as control), including 167 participants in each. The motivational intervention consisted of motivational interviewing, educational materials, use of an eHealth physical activity monitor and three group-based sessions. The primary outcome was body mass index (BMI) z score increments before and after the 12 (+3) months of intervention. Secondary outcomes (pre-post intervention) were: adherence to treatment, waist circumference (cm), fat mass index (z score), fat free mass index (z score), total body water (kg), bone mineral density (z score), blood lipids profile, glucose metabolism, and psychosocial problems. Other assessments (pre and post-intervention) were: sociodemographic information, physical activity, sedentary activity, neuropsychological testing, perception of body image, quality of the diet, food frequency consumption and foods available at home. The results of this clinical trial could open a window of opportunity to support professionals at the primary care to treat childhood obesity. The clinicaltrials.gov identifier was NCT02889406.