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Acute Flaxseed Intake Reduces Postprandial Glycemia in Subjects with Type 2 Diabetes: A Randomized Crossover Clinical Trial.
Moreira, FD, Reis, CEG, Welker, AF, Gallassi, AD
Nutrients. 2022;14(18)
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Glucose levels tend to rise postprandially in patients with type 2 diabetes. Flaxseeds are known to have glycaemic control-improving properties and are rich in dietary fibre, alpha-linolenic acid which is an omega-3 fatty acid and phenolic compounds such as phenolic acids, lignans, flavonoids and tocopherols. Therefore, this randomised cross-over clinical trial evaluated the effects of ground raw golden flaxseeds on postprandial glycaemia induced by the consumption of complex carbohydrates in Type 2 diabetic patients. To assess the 2-hour postprandial glycaemic curve, 19 male Type 2 diabetics were randomly assigned either to consume 15 grams of ground raw gold flaxseeds 15 minutes before eating a standardised balanced breakfast or to consume a standardised balanced breakfast without ground flaxseeds. Compared to men who did not consume ground flaxseeds before their breakfast meal, those who ate 15 grams of ground flaxseed were able to lower their postprandial glucose levels by 24% and reduce their peak glucose levels by 17%. In order to generalise the results for the general population, further robust long-term studies are required to examine the beneficial effects of flaxseed on postprandial glycaemic excursions. This study can, however, assist healthcare professionals in implementing dietary strategies that include flaxseed to manage postprandial blood sugar levels in patients with type 2 diabetes.
Abstract
BACKGROUND Postprandial glycemic excursions are associated with impairment control of diabetes mellitus. Long-term consumption of flaxseed can lower blood glucose levels; however, its effects on the postprandial glycemic response remain unknown. Therefore, this study aimed to evaluate the acute effects of raw flaxseed consumption on the 2 h postprandial glycemic curve in men with type 2 diabetes mellitus (T2DM). METHODS This was a randomized crossover clinical trial. Nineteen men with T2DM were randomly assigned a standardized breakfast without (control) or with a previous intake of 15 g of ground raw golden flaxseed (flax). Glycemia was measured at fasting and postprandial at 15, 30, 45, 60, 90, and 120 min. Palatability markers (visual appeal, smell, and pleasantness of taste) and taste intensity (sweetness, saltiness, bitterness, sourness, and creaminess) were evaluated. RESULTS The peak glucose rise and the 2 h AUC glycemic response reduced in the flax group by 17% (p = 0.001) and 24% (p < 0.001), respectively. The glucose peak time, palatability, and taste parameters did not differ between the two groups. CONCLUSIONS Ingestion of 15 g of ground raw golden flaxseed before breakfast decreases the 2 h postprandial glycemic response in men with T2DM.
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Effect of Intermittent Fasting on Reproductive Hormone Levels in Females and Males: A Review of Human Trials.
Cienfuegos, S, Corapi, S, Gabel, K, Ezpeleta, M, Kalam, F, Lin, S, Pavlou, V, Varady, KA
Nutrients. 2022;14(11)
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Intermittent fasting is a term for three different diet regimes. Alternate day fasting involves a feast day where individuals can eat what they want followed by a water only day. The 5:2 diet involves 5 feast days and 2 fast days per week. Time-restricted eating (TRE) involves a short eating window of a specific number of hours per day. Although these are all popular diet regimes for weight loss, animal studies have highlighted concerns with regards to reproductive health. This review paper aimed to summarise the human research on the effects of intermittent fasting on reproductive hormone levels in both men and women. It was found that overall, there were very few studies, however evidence was found on the effect of intermittent fasting on some of the sex hormones. For women, moving calorie intake to earlier in the day may be of benefit to oestrogen, sex hormone binding globulin, and androgen levels in those with polycystic ovary syndrome (PCOS). In addition, a fasting diet may be of benefit to androgen and SHBG levels in women with PCOS. However even though weight loss may be achieved with intermittent fasting, this is insufficient to improve the gonadotrophins. Intermittent fasting was found to be safe in women who were breastfeeding, with no significant change to milk production. In men, TRE was found to negatively affect testosterone levels, but had no effect on SHBG. The effect of intermittent fasting on sex hormones may involve changes in the gut microbiome and circadian rhythms as a direct result of intermittent fasting. It was concluded that the sex hormone levels of women with PCOS may benefit from intermittent fasting, however in men it may be detrimental to sex hormone production. This study could be used by healthcare professionals to understand that recommending an intermittent fasting diet may be of benefit to hormone levels and fertility in women with PCOS, however this may not be the case for men.
Abstract
Intermittent fasting is a popular diet for weight loss, but concerns have been raised regarding the effects of fasting on the reproductive health of women and men. Accordingly, we conducted this literature review to clarify the effects of fasting on reproductive hormone levels in humans. Our results suggest that intermittent fasting decreases androgen markers (i.e., testosterone and the free androgen index (FAI)) while increasing sex hormone-binding globulin (SHBG) levels in premenopausal females with obesity. This effect was more likely to occur when food consumption was confined to earlier in the day (eating all food before 4 pm). In contrast, fasting did not have any effect on estrogen, gonadotropins, or prolactin levels in women. As for men, intermittent fasting reduced testosterone levels in lean, physically active, young males, but it did not affect SHBG concentrations. Interestingly, muscle mass and muscular strength were not negatively affected by these reductions in testosterone. In interpreting these findings, it is important to note that very few studies have been conducted on this topic. Thus, it is difficult to draw solid conclusions at present. From the limited data presented here, it is possible that intermittent fasting may decrease androgen markers in both genders. If this is the case, these results would have varied health implications. On the one hand, fasting may prove to be a valuable tool for treating hyperandrogenism in females with polycystic ovarian syndrome (PCOS) by improving menstruation and fertility. On the other hand, fasting may be shown to decrease androgens among males, which could negatively affect metabolic health and libido. More research is warranted to confirm these preliminary findings.
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Effects of the 5:2 intermittent fasting diet on non-alcoholic fatty liver disease: A randomized controlled trial.
Kord Varkaneh, H, Salehi Sahlabadi, A, Găman, MA, Rajabnia, M, Sedanur Macit-Çelebi, M, Santos, HO, Hekmatdoost, A
Frontiers in nutrition. 2022;9:948655
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Non-alcoholic fatty liver disease (NAFLD) is associated with modifiable risk factors such as obesity, diabetes and metabolic syndrome. The 5:2 diet is an intermittent fasting regimen in which you fast for two days and eat liberally for five days per week. Time-restricted eating or intermittent fasting is a great way to limit energy intake and manage metabolic markers, making fasting diets like the 5:2 a viable option for the treatment of NAFLD. In this study, fifty patients with NAFLD were randomly assigned to either the intermittent fasting (5:2) or the control group. In the 5:2 group, the intervention resulted in a modest reduction in calorie intake. Participants on the 5:2 diet showed significant improvements in biomarkers of NAFLD, inflammatory markers, and body composition after 12 weeks of intervention. An evaluation of the effectiveness of a 5:2 diet on improving lipid profiles and diabetes requires further robust research. This study provides healthcare professionals insight into the benefits of implementing intermittent fasting as a cost-effective and safe therapeutic method.
Abstract
Background and aims: Dietary regimens are crucial in the management of non-alcoholic fatty liver disease (NAFLD). The effects of intermittent fasting (IF) have gained attention in this regard, but further research is warranted. Thus, we aimed to ascertain the overall effects of the 5:2 IF diet (5 days a week of normal food intake and 2 consecutive fasting days) in patients with NAFLD compared to a control group (usual diet). Methods and results: A 12-week randomized controlled trial was performed to evaluate the effects of the 5:2 IF diet on anthropometric indices, body composition, liver indices, serum lipids, glucose metabolism, and inflammatory markers in patients with NAFLD. The IF group (n = 21) decreased body weight (86.65 ± 12.57-82.94 ± 11.60 kg), body mass index (30.42 ± 2.27-29.13 ± 1.95 kg/m2), waist circumference (103.52 ± 6.42-100.52 ± 5.64 cm), fat mass (26.64 ± 5.43-23.85 ± 5.85 kg), fibrosis (6.97 ± 1.94-5.58 ± 1.07 kPa), steatosis scores/CAP (313.09 ± 25.45-289.95 ± 22.36 dB/m), alanine aminotransferase (41.42 ± 20.98-28.38 ± 15.21 U/L), aspartate aminotransferase (34.19 ± 10.88-25.95 ± 7.26 U/L), triglycerides (171.23 ± 39.88-128.04 ± 34.88 mg/dl), high-sensitivity C-reactive protein (2.95 ± 0.62 -2.40 ± 0.64 mg/L), and cytokeratin-18 (1.32 ± 0.06-1.19 ± 0.05 ng/ml) values compared to the baseline and the end of the control group (n = 23)-p ≤ 0.05 were considered as significant. However, the intervention did not change the levels of high-density lipoprotein cholesterol, total cholesterol, low-density lipoprotein cholesterol, fasting blood sugar, insulin, HOMA-IR, and total antioxidant capacity. Conclusion: Adhering to the 5:2 IF diet can reduce weight loss and related parameters (fat mass and anthropometric indicators of obesity), as well as hepatic steatosis, liver enzymes, triglycerides, and inflammatory biomarkers in patients with NAFLD.
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Linoleic Acid-Rich Oil Alters Circulating Cardiolipin Species and Fatty Acid Composition in Adults: A Randomized Controlled Trial.
Cole, RM, Angelotti, A, Sparagna, GC, Ni, A, Belury, MA
Molecular nutrition & food research. 2022;66(15):e2101132
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Dietary polyunsaturated fatty acid intake is associated with reduced cardiometabolic disease risk. In addition, higher linoleic acid (LA) biomarkers have been associated with a reduced risk for cardiometabolic diseases and conditions. The main aim of this study was to determine whether a modest addition of an oil rich in LA could change the LA content in plasma, erythrocytes, and peripheral blood mononuclear cells (PBMCs). The secondary aim was to determine if the LA-rich oil could alter cardiolipin species in PBMCs. This study is a randomised double-masked placebo-controlled study of 84 participants who were randomly assigned to one of the two groups: either the high-oleate-cookie (n = 42) or LA-cookie groups (n = 42). Results show that dietary supplementation with less than one serving of LA-rich oil per day increases LA in PBMC cardiolipin as well as LA levels. Authors conclude that patients with obesity, cardiometabolic disease, and other conditions related to mitochondrial dysfunction could be a future cohort that should be studied.
Abstract
SCOPE Higher circulating linoleic acid (LA) and muscle-derived tetralinoleoyl-cardiolipin (LA4 CL) are each associated with decreased cardiometabolic disease risk. Mitochondrial dysfunction occurs with low LA4 CL. Whether LA-rich oil fortification can increase LA4 CL in humans is unknown. The aims of this study are to determine whether dietary fortification with LA-rich oil for 2 weeks increases: 1) LA in plasma, erythrocytes, and peripheral blood mononuclear cells (PBMC); and 2) LA4 CL in PBMC in adults. METHODS AND RESULTS In this randomized controlled trial, adults are instructed to consume one cookie per day delivering 10 g grapeseed (LA-cookie, N = 42) or high oleate (OA) safflower (OA-cookie, N = 42) oil. In the LA-cookie group, LA increases in plasma, erythrocyte, and PBMC by 6%, 7%, and 10% respectively. PBMC and erythrocyte OA increase by 7% and 4% in the OA-cookie group but is unchanged in the plasma. PBMC LA4 CL increases (5%) while LA3 OA1 CL decreases (7%) in the LA-cookie group but are unaltered in the OA-cookie group. CONCLUSIONS LA-rich oil fortification increases while OA-oil has no effect on LA4 CL in adults. Because LA-rich oil fortification reduces cardiometabolic disease risk and increases LA4 CL, determining whether mitochondrial dysfunction is repaired through dietary fortification is warranted.
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The effects of olive leaf extract on cardiovascular risk factors in the general adult population: a systematic review and meta-analysis of randomized controlled trials.
Razmpoosh, E, Abdollahi, S, Mousavirad, M, Clark, CCT, Soltani, S
Diabetology & metabolic syndrome. 2022;14(1):151
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Modifiable unhealthy behaviours, such as sedentary lifestyle, smoking, and unhealthy food habits, are regarded as important contributors to the widespread prevalence of cardiovascular diseases (CVDs), which occur concurrently in overweight/obesity, hypertension, dyslipidaemia, hyperglycaemia, and inflammation. The aim of this study was to investigate whether olive leaf extract (OLE) could improve the major cardiovascular-related variables, including lipid profile, glucose haemostasis, blood pressure, as well as liver/kidney and inflammatory markers in the general adult population. This study is a systematic review and meta-analysis of twelve randomised controlled studies. Results show that OLE supplementation: - significantly decreased triglycerides and systolic blood pressure levels. - only had short-term positive effects on blood pressure and lipid profiles, which may be attributed to the active constituents in OLE. - had more profitable effects on the improvement of triglycerides, blood pressure, total cholesterol and low-density lipoprotein cholesterol measures among participants with hypertension and individuals with normal body weight. Authors conclude that stronger randomised controlled trial investigations, assessing different doses and durations of OLE, are required to better elucidate the effects of OLE supplementation.
Abstract
BACKGROUND The aim of this systematic review and meta-analysis was to determine the effect of olive leaf extract (OLE) supplementation on cardiovascular-related variables, including lipid, glycemic, inflammatory, liver and renal-related factors, as well as blood pressure. METHODS PubMed, ISI Web of Science, Scopus, and Cochrane library were searched, up to October 2021, for relevant controlled trials. Mean differences and standard deviations were pooled for all outcomes, using a random-effects model. The methodological quality, as well as quality of evidence were assessed using standard tools. RESULTS Twelve studies (n = 819 participants) were included in our analyses. Overall analyses showed that OLE supplementation significantly decreased triglyceride (TG) levels (WMD = - 9.51 mg/dl, 95% CI - 17.83, - 1.18; P = 0.025; I2 = 68.7%; P-heterogeneity = 0.004), and systolic blood pressure (SBP) (WMD = - 3.86 mmHg, 95% CI - 6.44, - 1.28 mmHg; P = 0.003; I2 = 19.9%; P-heterogeneity = 0.28). Subgroup analyses also revealed a significant improvement in SBP (- 4.81 mmHg) and diastolic blood pressure (- 2.45 mmHg), TG (- 14.42 mg/dl), total cholesterol (TC) (- 9.14 mg/dl), and low-density lipoprotein-C (LDL-C) (- 4.6 mg/dl) measurements, in patients with hypertension. Significant reductions were also observed in TC (- 6.69 mg/dl), TG (- 9.21 mg/dl), and SBP (- 7.05 mmHg) in normal-weight individuals. However, no meaningful changes were seen in glucose hemostasis, liver and kidney, or inflammatory markers. CONCLUSION The present study revealed that supplementation with OLE yielded beneficial effects for blood pressure and lipid profile in adults, especially in patients with hypertension. As the quality of evidence for glucose hemostasis variables, liver, kidney, and inflammatory markers, were low-to-very low, higher quality RCTs may impact the overarching results. This study was registered at PROSPERO with the code CRD42022302395.
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The Effect of Yoga on the Lipid Profile: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.
Ghazvineh, D, Daneshvar, M, Basirat, V, Daneshzad, E
Frontiers in nutrition. 2022;9:942702
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Modernisation has brought increased comforts and limited mobility in our lives at the cost of an increased prevalence of hypertension, diabetes mellitus, dyslipidaemia, and obesity, which are predecessors of major cardiovascular diseases. Prevention and control of coronary heart disease and its associated diseases are essential and can be achieved by modifying the lipid profile. The aim of this study was to systematically assess the effects of yoga on blood lipid levels. This study is a systematic review and meta-analysis of fifty-three randomised controlled studies. All studies employed a parallel design with a total of 13,191 participants whom were divided into 6,700 individuals in the control group and 6,517 in the intervention group. Results show that yoga had decreased total cholesterol, low-density lipoprotein cholesterol, triglycerides, and very low-density lipoprotein cholesterol and increased high-density lipoprotein cholesterol among yoga practitioners. Authors conclude that yoga had a striking effect on balancing lipid profiles.
Abstract
OBJECTIVES Yoga is a mind-body stress-relieving exercise that increases mental and physical health, which may have a role in the improvement of metabolic disorders. The present study has reviewed the effect of yoga on lipid profiles as a systematic review and meta-analysis. METHODS We evaluated the available randomized controlled trials on the effects of yoga-based programs, and lipid profiles by searching PubMed/Medline, Scopus, Web of Science, and the Cochrane central register of control trials up to January 2022. Both fixed and random effect analyses were used to find the relationships. Subgroup analysis was performed based on the continent, duration of the included studies, gender, and health condition of participants to discover the sources of heterogeneity. RESULT Fifty-three studies were included in the current systematic review and meta-analysis with a total sample size of 13,191. There was a striking association between yoga and total cholesterol (-10.31 mg/dl; 95% CI: -14.16, -6.45; I 2 = 82.5%, P < 0.001), low-density lipoprotein cholesterol (-8.64 mg/dl; 95% CI: -12.03, -5.25; I 2 = 75.0%, P < 0.001), high-density lipoprotein cholesterol (1.98 mg/dl; 95% CI: 0.81, 3.14; I 2 = 91.6%, P < 0.001), triglycerides (-13.50 mg/dl; 95% CI: -20.09, -6.92; I 2 = 90.7%, P < 0.001) and very low-density lipoprotein (-3.94 mg/dl; 95%CI: -6.31, -1.56; I 2 = 72.2%, P < 0.001). CONCLUSION It seems yoga interventions had a substantial effect on lipid profiles, however, more qualified trials or cohort studies are needed to conclude exactly.
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The effects of berberine supplementation on cardiovascular risk factors in adults: A systematic review and dose-response meta-analysis.
Zamani, M, Zarei, M, Nikbaf-Shandiz, M, Hosseini, S, Shiraseb, F, Asbaghi, O
Frontiers in nutrition. 2022;9:1013055
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Despite advances in medicine, cardiovascular disease (CVD) still remains the primary cause of deaths worldwide. Many of the risk factors of CVD, such as elevated levels of blood fats, high blood pressure, abdominal obesity and poor blood sugar control, can be improved and managed by behaviour, lifestyle and dietary intervention as well as supplements. Berberine (BBR) is a plant-derived compound, available as a supplement, which has gained the attention of researchers due to its ability to modulate cardiovascular risk factors. This dose-response meta-analysis sought to generate a comprehensive overview of the effect of BBR on the risk factors for CVD in adults. The analysis included 49 randomised clinical trials. The results showed BBR significantly reduced blood fats such as total cholesterol, triglycerites and low-density lipoprotein (LDL). It also improved markers of blood sugar control such as fasting blood sugar levels, insulin, HbA1c, HOMA-IR and blood pressure and body weight, whilst enhancing high-density lipoprotein (HDL). The optimal dose of BBR was 1 g/day for triglycerides, total cholesterol, and weight loss. For insulin and HOMA-IR the best effects were seen with 1.8 g/day and for HDL 5 g/day. The most effective timeframe to impact fasting blood sugars seemed to be 40 weeks, and 50 weeks to influence blood pressure and waist circumference. In conclusion, BBR supplementation had beneficial effects on reducing risk factors for CVD, particularly in subgroups with impaired metabolic health. There was no substantial impact on liver enzymes (AST, ALT) or inflammatory markers (CRP, IL-6). Furthermore the supplement was largely ineffective in people with normal body mass index.
Abstract
UNLABELLED Cardiovascular disease (CVD) is a major concern today. Herbal medicine is one helping way to control CVD risks. One conclusive of herbal medicine is Berberine (BBR) and converse about it still exists, to clarify this issue, this meta-analysis was performed. PubMed/Medline, Scopus, and Web of Science were searched for RCTs in adults on the effect of BBR supplementation on CVD risk factors up to July 2022. The pooled results showed BBR significantly reduced triglyceride (WMD = -23.70 mg/dl; 95%CI -30.16, -17.25; P < 0.001), total cholesterol (WMD = -20.64 mg/dl; 95%CI -23.65, -17.63; P < 0.001), low-density lipoprotein WMD = -9.63 mg/dl; 95%CI, -13.87, -5.39; P < 0.001), fasting blood glucose (FBG) (WMD = -7.74 mg/dl; 95%CI -10.79, -4.70; P < 0.001), insulin (WMD = -3.27 mg/dl; 95%CI -4.46,-2.07; P < 0.001), HbA1c (WMD = -0.45%; 95%CI -0.68, -0.23; P < 0.001), HOMA-IR (WMD = -1.04; 95%CI -1.55, -0.52; P < 0.001), systolic blood pressure (WMD = -5.46 mmHg; 95%CI -8.17, -2.76; P < 0.001), weight (WMD = -0.84; 95%CI -1.34,-0.34; P < 0.001), body mass index (WMD = -0.25 kg/m2; 95%CI -0.46, -0.04; P = 0.020), while increased high-density lipoprotein (HDL) (WMD = 1.37 mg/dl; 95%CI 0.41,2.23; P = 0.005). The optimal dose of BBR was 1 g/day for TG, TC, and weight, 1.8 g/day for insulin and HOMA-IR, and 5 g/day for HDL. FBG's most efficient time frame was 40 weeks from the beginning of supplementation, whereas DBP and waist circumference was 50 weeks. In conclusion, the lipid profile, FBG balance, obesity parameters, and SBP were improved with BBR supplementation. SYSTEMATIC REVIEW REGISTRATION CRD42022347004.
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Effects of the Treatment with Flavonoids on Metabolic Syndrome Components in Humans: A Systematic Review Focusing on Mechanisms of Action.
Gouveia, HJCB, Urquiza-Martínez, MV, Manhães-de-Castro, R, Costa-de-Santana, BJR, Villarreal, JP, Mercado-Camargo, R, Torner, L, de Souza Aquino, J, Toscano, AE, Guzmán-Quevedo, O
International journal of molecular sciences. 2022;23(15)
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Metabolic syndrome is a condition characterised by at least three of the five risk factors, such as abdominal obesity, elevated fasting glucose, blood pressure and triglycerides and reduced high-density lipoprotein cholesterol (HDL-c). There is a strong link between metabolic syndrome and the development of cardiovascular disease and Type 2 diabetes. Research suggests that increasing consumption of flavonoid-rich foods can be beneficial in reducing cardiovascular morbidity and mortality. Flavonoids are bioactive compounds that possess antioxidative, anti-inflammatory, anti-cancerous, anti-mutagenic, and enzymatic properties. This systematic review of 29 randomised controlled trials evaluated the beneficial effects of long-term flavonoid supplementation in reducing the risk factors of metabolic syndrome. This review included a variety of flavonoid supplements, such as anthocyanin, hesperidin, quercetin, epigallocatechin gallate (egcg), genistein, theaflavin, catechin, and eriocitrin. Additionally, this research investigated the mechanisms behind the beneficial effects of flavonoid supplementation. Results showed that flavonoid supplementation for at least three weeks improved metabolic parameters and inflammatory markers, with hesperidin showing the greatest improvements in metabolic parameters. Healthcare professionals can use these findings to understand the potential benefits of long-term flavonoid supplementation in improving metabolic parameters. However, more robust studies are needed to determine the therapeutic dosages of different flavonoids.
Abstract
Diets high in bioactive compounds, such as polyphenols, have been used to mitigate metabolic syndrome (MetS). Polyphenols are a large group of naturally occurring bioactive compounds, classified into two main classes: non-flavonoids and flavonoids. Flavonoids are distributed in foods, such as fruits, vegetables, tea, red wine, and cocoa. Studies have already demonstrated the benefits of flavonoids on the cardiovascular and nervous systems, as well as cancer cells. The present review summarizes the results of clinical studies that evaluated the effects of flavonoids on the components of the MetS and associated complications when offered as supplements over the long term. The results show that flavonoids can significantly modulate several metabolic parameters, such as lipid profile, blood pressure, and blood glucose. Only theaflavin and catechin were unable to affect metabolic parameters. Moreover, only body weight and body mass index were unaltered. Thus, the evidence presented in this systematic review offers bases in support of a flavonoid supplementation, held for at least 3 weeks, as a strategy to improve several metabolic parameters and, consequently, reduce the risk of diseases associated with MetS. This fact becomes stronger due to the rare side effects reported with flavonoids.
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A Double-Blind, Placebo-Controlled Randomized Phase IIa Study: Evaluating the Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Solid Cancer Patients.
Chaiworramukkul, A, Seetalarom, K, Saichamchan, S, Prasongsook, N
Asian Pacific journal of cancer prevention : APJCP. 2022;23(7):2333-2340
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Cancer anorexia–cachexia syndrome (CACS) is usually found in advanced cancer patients. CACS is a multifactorial process which comprises skeletal muscle and adipose tissue loss which may be compounded by anorexia and a dysregulated metabolic state. The hypothesis of this study was that curcumin will increase body compositions and body weight in patients with solid malignancy and CACS when compared to placebo after adjusting by age, gender, primary site of cancer, stage of cancer, performance status, and supplementary nutrition support. This study was a double-blind, placebo-controlled randomised phase lla study. A total of 46 patients were enrolled, of whom 33 underwent 1:1 block of four randomisations. Seventeen patients were randomly assigned to receive curcumin at dose of 800 mg twice daily orally and sixteen patients were randomly assigned to received placebo. Results show that curcumin supplementation: (1) did not statistically significantly improve body compositions and body weight when compared to placebo; (2) may cause clinical benefit in term of hand grip muscle strength and slow progress of CACS by decreasing in basal metabolic rate and preventing the decline in serum albumin; and (3) administered orally for two months at a dose of up to 2 grams daily appeared safe and no serious adverse events were reported. Authors conclude that curcumin inhibited process of CACS via reduction of basal metabolic rate and slowed down the progression of hand-grip muscle strength loss. Furthermore, nuclear factor kappa B [regulator of gene expression] levels merit further exploration as potentially suitable predictive biomarker for CACS treatment with curcumin.
Abstract
OBJECTIVE We aim to investigate the effect of curcumin on preventing cancer anorexia-cachexia syndrome (CACS) via through mechanism of inhibition on NF-kB signal pathway. Outcome measurement for primary end point was improvement of body tissue composition, and the secondary end points were body weight and body mass index, hand grip muscle strengthening, and safety. METHODS This is randomized, double-blind, placebo-controlled phase ll a study, 33 patients with CACS in solid malignancy were enrolled and randomized in 1:1 to receive oral curcumin (at a dose of 800 mg twice daily) or placebo for 8 weeks. RESULTS All parameters of body compositions were not statistically significant different between two groups, which were consist body fat mass [-1.25(SEM 0.87) vs. +0.63(SEM 0.55); p=0.119], skeletal muscle mass [-0.35(SEM 0.60) vs.+0.33(SEM 0.42); p=0.408] and percent body fat [-0.47(SEM 0.95) vs. -0.29(SEM 0.82); p=0.893] including with basal metabolic rate [-13.47(SEM 21.94) vs. +15.30(13.76); p=0.336]. The average of weight loss was also not statistically significant different between two groups. [-1.4 kg(SEM 0.89) in curcumin vs-1.12 kg(SEM 0.73), p=0.810]. Notably, patient with curcumin had less reduction of hand-grip muscle strength on both hands [Rt. handed: -2.47 in curcumin vs. -5.36 in placebo; p=0.318] [Lt. handed: -1.98 vs. -5.43; p=0.317], and basal metabolic rate than placebo group. Most adverse events were grade 1 on both groups similarly. CONCLUSION Curcumin was not shown to be superior to placebo with regard to increasing the body composition in cancer patients with CACS. However, curcumin might show some clinical benefits, including slow progression of hand-grip muscle strength loss, and basal metabolic rate. Further investigations should be explored.
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Testosterone does not affect lower urinary tract symptoms while improving markers of prostatitis in men with benign prostatic hyperplasia: a randomized clinical trial.
Rastrelli, G, Cipriani, S, Lotti, F, Cellai, I, Comeglio, P, Filippi, S, Boddi, V, Della Camera, PA, Santi, R, Boni, L, et al
Journal of endocrinological investigation. 2022;45(7):1413-1425
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Benign prostatic hyperplasia (BPH) — also called benign prostate enlargement — is frequent in aging populations, with a 40 – 50% prevalence in men aged 50–60 years and up to 90% in men older than 80 years. The aim of this study was to verify whether testosterone therapy (TTh) in men with BPH, metabolic syndrome (MetS) and low testosterone is able to improve lower urinary tract symptoms (LUTS) and intraprostatic inflammation. This study is a double blind, randomised 24-week clinical trial in men with low testosterone and MetS and a candidate for prostate surgery for BPH. Patients (n=144) were centrally randomised 1:1 to one of the two groups; TTh or placebo. Results show that TTh administered for 24 weeks is a safe option and it improves prostatic inflammatory features thus ameliorating one of the pathogenic components of BPH. However, there were no differences in improvements of the urinary symptoms between both groups (TTh and placebo). Authors conclude that decreased inflammation is not accompanied by a consistent improvement in urinary symptoms, and that their findings show the safety of TTh in subjects with BPH of surgical significance.
Abstract
PURPOSE Benign Prostatic Hyperplasia (BPH) is a result of prostate inflammation, frequently occurring in metabolic syndrome (MetS). Low testosterone is common in MetS. A randomized clinical trial was designed to evaluate if 24 weeks of testosterone therapy (TTh) in BPH men with MetS and low testosterone improve urinary symptoms and prostate inflammation. METHODS One-hundred-twenty men with MetS waitlisted for BPH surgery were enrolled. They were categorized into normal testosterone (TT ≥ 12 nmol/L and cFT ≥ 225 pmol/L; n = 48) and testosterone deficient (TD) (TT < 12 nmol/L and/or cFT < 225 pmol/L; n = 72) then randomized to testosterone gel 2% (5 g/daily) or placebo for 24 weeks. At baseline and follow-up, questionnaires for urinary symptoms and trans-rectal ultrasound were performed. Prostate tissue was collected for molecular and histopathological analyses. RESULTS No differences in the improvement of urinary symptoms were found between TTh and placebo (OR [95% CI] 0.96 [0.39; 2.37]). In TD + TTh, increase in prostate but not adenoma volume was observed (2.64 mL [0.07; 5.20] and 1.82 mL [- 0.46; 0.41], respectively). Ultrasound markers of inflammation were improved. In a subset of 61 men, a hyper-expression of several pro-inflammatory genes was found in TD + placebo when compared with normal testosterone. TTh was able to counteract this effect. For 80 men, the inflammatory infiltrate was higher in TD + placebo than in normal testosterone (0.8 points [0.2; 1.4]) and TD + TTh men (0.9 points [0.2; 1.5]). CONCLUSIONS Twenty-four weeks of TTh in TD men with BPH and MetS improves ultrasound, molecular and histological proxies of prostate inflammation. This does not result in symptom improvement.