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Polypill News and Research

May 30, 2011 Written by JP       [Font too small?]

The types of products that doctors recommend and manufacturers produce reveal a lot about what they think of us as health care consumers. A prevalent view in both alternative and conventional medicine is that most patients would rather take a so-called “magic bullet” that improves disease markers and/or symptoms rather than address the root cause of  illnesses. The idea is that patients are either too busy or unmotivated to make the dietary and lifestyle changes that are necessary to improve health. Sadly, this widely held notion is often based in reality.

If we could somehow wipe cardiovascular disease (CVD) off the face of the Earth, the majority of preventable disease and a significant proportion of health care spending would disappear along with it. This truism is the inspiration for a new type of prescription medication known as a “polypill”. The name polypill refers to a single capsule that contains several medications that address cardiovascular threats such as abnormal blood clotting, high blood pressure and high LDL (“bad”) cholesterol. The target audience for this new generation drug are men and women over the age of 55 who are marginally at risk. According to some estimates, use of a polypill could potentially lead to a reduction in cases of CVD of up to 3.2 million/decade and a decline in strokes of 1.7 million/decade in the U.S. alone. (1)

A new study published in the current edition of PLoS One tested the efficacy and safety of a polypill in a group of 378 older adults living in seven different countries. Half the group was given a once daily capsule containing 75 mg aspirin, 12.5 mg hydrochlorothiazide,10 mg lisinopril and 20 mg simvastatin. The remainder was provided with a placebo in a double-blind fashion, ie. neither the researchers nor the patients knew it was a placebo. Blood tests were taken at baseline and at a 12 week follow-up appointment. (2,3)

  • Those receiving the polypill demonstrated a decline in LDL cholesterol (3.7 mmol/L to 2.9 mmol/L) and systolic blood pressure (134 mm Hg to 124.1 mmg Hg).
  • A total of 58% of the treatment group reported adverse reactions and 23% dropped out of the trial because of side effects.

A previous study from August 2010 examined the impact of a slightly different polypill over a 12 month period in 475 middle-aged to senior adults. In that instance, “The effects of the polypill on blood pressure and lipid levels were less than anticipated”. (4)

A much healthier approach to addressing cardiovascular risk is outlined in the May 25th edition of the Journal of Medicinal Food. In the research, a “Spanish Ketogenic Mediterranean Diet” was tested for 12 weeks in a small group of patients with metabolic syndrome – a confluence of risk factors pertaining to cardiovascular disease and diabetes. This very low-carb version of Mediterranean eating resulted in dramatic improvements in virtually all of the areas of threat.

  • LDL (“bad”) cholesterol declined from 126.25 mg/dL to 103.87 mg/dL. HDL (“good”) cholesterol rose from 44.44 mg/dL to 57.95 mg/dL.
  • Blood pressure similarly improved: diastolic BP (89.09 mm Hg to 76.36 mm Hg) and systolic (141.59 mm Hg to 123.64 mm Hg).
  • Positives changes in body weight (106.41 kg to 91.95 kg) and waist circumference (111.97 cm to 94.70 cm) were recorded.

As if this wasn’t enough, fasting blood sugar and plasma triglycerides also transitioned to a much healthier range – blood glucose (118.81 mg/dL to 91.86 mg/dL) and triglycerides (224.86 mg/dL to 109.59 mg/dL). By the completion of the study, all of the participants were deemed free of metabolic syndrome. This is an extraordinary finding that puts most CVD drug intervention studies to shame. What’s more, a paper published over six years ago in the British Medical Journal estimated that a “polymeal” style diet, centering around almonds, dark chocolate, fish, fruit, garlic and vegetables could safely reduce cardiovascular disease events by 76%. (5,6,7)

Regular Exercise Training is Another “Polypill” Alternative

Source: Cardiovasc Diabetol. 2011 Jan 28;10:12. (link)

Now some of you may be thinking that only conventional medical doctors are behind the push for easy solutions to major health issues such as heart disease. This is not the case. A study published in the May-June Journal of Clinical Lipidology describes how a “phytochemical-rich medical food” can and should be used in addition to a low-glycemic Mediterranean style diet. According to researchers at the Department of Nutritional Sciences at the University of Connecticut Storrs, a soy-based protein shake can enhance the benefits of a Mediterranean diet by additively lowering apolipoprotein, (LDL) cholesterol and homocysteine concentrations. But, a close review of the composition of the product, UltraMeal PLUS 360°, reveals the second most prominent ingredient in the formula is fructose. Why fructose is included in a supplement intended to address metabolic syndrome is a mystery to me, to put it kindly. (8,9,10)

In the coming year I hope to share some very exciting news about a proposed study that could, once and for all, place nutrition as a first line approach to addressing cardiovascular disease. The implications cannot be under-emphasized. The results of such a trial would likely revolutionize the way modern medicine is practiced while saving countless lives and incalculable healthcare resources worldwide. In practical terms, this would mean that in the future, doctors could prescribe and support patients in adopting a new way of eating rather than just prescribing yet another questionable drug. The challenge is to find the best way to fund the type of research that some prominent scientists are ready to carry out. This may require a grass roots effort to raise funds en masse or reaching out to a single or multiple major donors who are interested in backing one of the most important nutritional studies in the history of modern medicine. If you know any individuals or organizations that may want to get involved in this invaluable research, please let me know. In the meantime, try to put the preliminary data I’ve shared with you today to maximum affect.

Note: Please check out the “Comments & Updates” section of this blog – at the bottom of the page. You can find the latest research about this topic there!

Be well!

JP

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13 Comments & Updates to “Polypill News and Research”

  1. JP Says:

    Another option: tomato juice …

    http://www.sciencedirect.com/science/article/pii/S027869151400386X

    Food Chem Toxicol. 2014 Sep 3.

    Dietary supplementation with tomato-juice in patients with metabolic syndrome: A suggestion to alleviate detrimental clinical factors.

    Lycopene, a carotenoid, is known for its antioxidant properties. Little is known, though, about the relationship of dietary tomato-juice intake and risks factors, like inflammation, insulin resistance and hyperlipidemia, implicated in metabolic syndrome. In the present study, we examined whether supplementation with tomato-juice has any implication on the risk status of patients with metabolic syndrome. A comparative study was conducted in 27 individuals diagnosed with metabolic syndrome. Fifteen of them were instructed to use commercially available tomato-juice as refreshment 4 times a week over a period of two months and twelve individuals served as the control group. Several parameters reflective of the metabolic syndrome were monitored both in the group supplemented with tomato juice and in the control group (ADMA for entdothelial function, TNF-α and IL-6 for inflammation, FIRI for insulin resistance). There was a significant improvement in the inflammation status and the endothelial dysfunction of the tomato-juice supplemented patients. At the same time, insulin resistance improved and a pronounced decrease in LDL was recorded, along with a slight increase in HDL. The results of the present study suggest an alleviating effect of tomato-juice with regard to risk factors associated with metabolic syndrome.

    Be well!

    JP

  2. JP Says:

    Update 04/20/15:

    http://www.biomedcentral.com/1472-6882/15/52

    BMC Complementary and Alternative Medicine 2015, 15:52

    Can red yeast rice and olive extract improve lipid profile and cardiovascular risk in metabolic syndrome?: A double blind, placebo controlled randomized trial

    Background: Metabolic syndrome (MetS) comprises a spectrum of clinical phenotypes in which dyslipidemia, dysglycemia and hypertension are clustered and where all share a high level of oxidative stress and an increased risk of cardiovascular disease. This study examines the effect of a nutritional supplement combining red yeast rice and olive fruit extract on the lipid profile and on oxidative stress in a population of patients with MetS.

    Methods: In a double blind placebo controlled randomized trial, 50 persons with MetS, as defined by the ATPIII criteria, received the study product or placebo for 8 weeks. The study product contained 10.82 mg of monacolins and 9,32 mg of hydroxytyrosol per capsule, and is commercialized as Cholesfytol plus. The primary outcome measure was the difference in LDL reduction between intervention and control groups. Furthermore, differences in changes of CH, HDL, ApoA1, ApoB, HbA1c and oxLDL were measured, as well as side-effects, CK elevation, changes in clinical parameters and in cardiovascular risk.

    Results: In the intervention group, LDL cholesterol was lowered by 24% whereas it increased by 1% in the control group (p < 0.001). Other effects observed were a change in total cholesterol (−17% in the intervention group vs +2% in the control group, p < 0.001), apolipoprotein B (−15% vs +6%, p < 0.001), and TG (−9% vs + 16%, p = 0.02). Oxidized LDL decreased by 20% vs an increase of 5% in the control group (p < 0.001). Systolic and diastolic arterial blood pressure decreased significantly by 10 mmHg (vs 0% in the control group, p = 0.001) and 7 mmHg (vs 0% in the control group, p = 0.05) respectively. One person in the intervention group, who suffered from Segawa’s syndrome, dropped out because of severe muscle ache.

    Conclusions: The combination of active products in this study may be an alternative approach to statins in people who do not need, or cannot or do not want to be treated with chemical statins. Side effects, effects on oxidative stress and on glucose metabolism need to be examined more thoroughly.

    Be well!

    JP

  3. JP Says:

    Update 04/21/15:

    http://www.jdmdonline.com/content/14/1/22

    J Diabetes Metab Disord. 2015 Apr 9;14:22.

    Improvement of glucose and lipid profile status with Aloe vera in pre-diabetic subjects: a randomized controlled-trial.

    BACKGROUND: Pre-diabetes is a disturbing trend in the population, who are at risk of developing type-two diabetes. The aim of this study was to determine the effects use of Aloe vera in different doses on glucose and lipid profile in pre-diabetic subjects.

    METHODS: This study was a double blind randomized controlled trial (72 subjects) with pre-diabetes symptoms in 3 groups consumed capsules twice a day: Aloe vera 300 mg (AL300), 500 mg (AL500) and placebo (PL). Fasting blood glucose (FBS), HbA1C and lipid profile were evaluated in baseline, 4 or 8 weeks. On-way ANOVA, Friedman, Wilcoxon, Kruskal-Wallis , Mann-Whitney and Chi-square tests were used for within or between groups statistical analysis.

    RESULTS: FBS level in group AL300, showed significantly decreased in fourth week after the intervention, compared to PL in the same time (p = 0.001). Also, HbA1C level in this group at the eighth week after the intervention (p = 0.042), had a significant decrease. The levels of Total cholesterol and LDL-C, only in the group AL500 (p < 0.001 and p = 0.01), was significantly reduced, along with HDL-C level improvement just after eight weeks (p = 0.004). Triglyceride level showed a significant decrease (p < 0.045) just after four weeks use of AL500.

    CONCLUSIONS: The Use of Aloe vera extract in pre-diabetic patients, could revert impaired blood glucose within four weeks, but after eight weeks could alleviate their abnormal lipid profile.

    Be well!

    JP

  4. JP Says:

    Updated 09/06/15:

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4390209/

    J Med Food. 2015 Apr;18(4):415-20.

    Supplementation of a standardized extract from Phyllanthus emblica improves cardiovascular risk factors and platelet aggregation in overweight/class-1 obese adults.

    The objective of this study (clinicaltrials.gov NCT01858376) was to determine the effect of oral supplementation of a standardized extract of Phyllanthus emblica (CAPROS(®)) on cardiovascular disease (CVD) risk factors in overweight adult human subjects from the US population. Overweight/Class-1 obese (body-mass index: 25-35) adult subjects received 500 mg of CAPROS supplement b.i.d for 12 weeks. The study design included two baseline visits followed by 12 weeks of supplementation and then 2 weeks of washout. At all visits, peripheral venous blood was collected in sodium citrate tubes. Lipid profile measurements demonstrated a significant decrease in calculated low-density lipoprotein cholesterol and total cholesterol/high-density lipoprotein following 12 weeks of CAPROS supplementation when compared to averaged baseline visits. Circulatory high-sensitivity C reactive protein (hs-CRP) levels were significantly decreased after 12 weeks of supplementation. In addition, both ADP- and collagen-induced platelet aggregation was significantly downregulated following 12 weeks of supplementation. Overall, the study suggests that oral CAPROS supplementation may provide beneficial effects in overweight/Class-1 obese adults by lowering multiple global CVD risk factors.

    Be well!

    JP

  5. JP Says:

    Updated 05/09/16:

    http://www.nutritionjrnl.com/article/S0899-9007%2815%2900461-X/abstract

    Nutrition. 2016 Jun;32(6):716-9.

    Beneficial effects of Bifidobacterium lactis on lipid profile and cytokines in patients with metabolic syndrome: A randomized trial. Effects of probiotics on metabolic syndrome.

    OBJECTIVE: Human studies have shown the beneficial effects of probiotic microorganisms on the parameters of metabolic syndrome (MetS) and other cardiovascular risks, but to our knowledge the effect of Bifidobacterium lactis has not yet been reported. The aim of this study was to evaluate the effect of consumption of milk containing the probiotic B. lactis HN019 on the classical parameters of MetS and other related cardiovascular risk factors.

    METHODS: Fifty-one patients with MetS were selected and divided into a control group (n = 25) and a probiotic group (n = 26). The probiotic group consumed fermented milk with probiotics over the course of 45 d. The effects of B. lactis on lipid profile, glucose metabolism, and proinflammatory cytokines (tumor necrosis factor-α and interleukin-6) were assessed in blood samples of the individuals at the baseline and after 45 d.

    RESULTS: Daily ingestion of 80 mL fermented milk with 2.72 × 10(10) colony-forming units of B. lactis HN019 showed significant reduction in body mass index (P = 0.017), total cholesterol (P = 0.009), and low-density lipoprotein (P = 0.008) compared with baseline and control group values. Furthermore, a significant decrease in tumor necrosis factor-α (P = 0.033) and interleukin-6 (P = 0.044) proinflammatory cytokines was observed.

    CONCLUSION: These data showed potential effects of B. lactis HN019 in reducing obesity, blood lipids, and some inflammatory markers, which may reduce cardiovascular risk in patients with MetS.

    Be well!

    JP

  6. JP Says:

    Updated 07/14/16:

    http://link.springer.com/article/10.1007%2Fs40618-016-0507-8

    J Endocrinol Invest. 2016 Jul 11.

    Effect of high-dose vitamin D supplementation on cardiometabolic risk factors in subjects with metabolic syndrome: a randomized controlled double-blind clinical trial.

    PURPOSE: The evidence in support of the effect of vitamin D deficiency on cardiovascular diseases is inconsistent. The objective of this randomized, controlled, double-blind study was to assess the effect of high-dose vitamin D supplementation on cardiometabolic risk factors in subjects with metabolic syndrome.

    METHODS: Eighty subjects were randomized to receive 50,000 IU vitamin D or matching placebo weekly for 16 weeks. Fasting blood sugar, homeostasis model assessment of insulin resistance, insulin sensitivity (Quicki), serum lipid profiles (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride (TG) and total cholesterol), anthropometric factors and blood pressure were assessed before and after intervention. Dietary intake and sun exposure were also determined.

    RESULTS: Participants were 40.49 ± 5.04 years and 49 % male. All of the intervention group and 97 % of placebo group were vitamin D deficient or insufficient (25-hydroxyvitamin D <75 nmol/L). After intervention, serum 25(OH)D concentration was increased by 61.93 nmol/L in intervention group, while it was decreased in placebo group (p < 0.001). There was a significant change in TG concentration after 4 months (p < 0.001). Other metabolic or anthropometric factors did not change significantly (p = 0.05).

    CONCLUSION: Supplementation with high-dose vitamin D for 4 months improved vitamin D status and decreased TG levels in subjects with metabolic syndrome. However, it did not have any beneficial effects on other cardiometabolic risk factors; this might be due to the inadequate vitamin D status attained in this study which was conducted in a severely deficient region.

    Be well!

    JP

  7. JP Says:

    Updated 09/07/16:

    http://www.internationaljournalofcardiology.com/article/S0167-5273(16)32027-7/fulltext

    Int J Cardiol. 2016 Aug 23;223:992-998.

    Associations between branched chain amino acid intake and biomarkers of adiposity and cardiometabolic health independent of genetic factors: A twin study.

    BACKGROUND: Conflicting data exist on the impact of dietary and circulating levels of branched chain amino acids (BCAA) on cardiometabolic health and it is unclear to what extent these relations are mediated by genetics.

    METHODS: In a cross-sectional study of 1997 female twins we examined associations between BCAA intake, measured using food frequency-questionnaires, and a range of markers of cardiometabolic health, including DXA-measured body fat, blood pressure, HOMA-IR, high-sensitivity C-reactive protein (hs-CRP) and lipids. We also measured plasma concentrations of BCAA and known metabolites of amino acid metabolism using untargeted mass spectrometry. Using a within-twin design, multivariable analyses were used to compare the associations between BCAA intake and endpoints of cardiometabolic health, independently of genetic confounding.

    RESULTS: Higher BCAA intake was significantly associated with lower HOMA-IR (-0.1, P-trend 0.02), insulin (-0.5μU/mL, P-trend 0.03), hs-CRP -0.3mg/L, P-trend 0.01), systolic blood pressure (-2.3mmHg, P-trend 0.01) and waist-to-height ratio (-0.01, P-trend 0.04), comparing extreme quintiles of intake. These associations persisted in within-pair analysis for monozygotic twins for insulin resistance (P<0.01), inflammation (P=0.03), and blood pressure (P=0.04) suggesting independence from genetic confounding. There was no association between BCAA intake and plasma concentrations, although two metabolites previously associated with obesity were inversely associated with BCAA intake (alpha-hydroxyisovalerate and trans-4-hydroxyproline).

    CONCLUSIONS: Higher intakes of BCAA were associated, independently of genetics, with lower insulin resistance, inflammation, blood pressure and adiposity-related metabolites. The BCAA intake associated with our findings is easily achievable in the habitual diet.

    Be well!

    JP

  8. JP Says:

    Updated 10/02/16:

    https://www.ncbi.nlm.nih.gov/pubmed/27658130

    J Pediatr Endocrinol Metab. 2016 Sep 22.

    One month of omega-3 fatty acid supplementation improves lipid profiles, glucose levels and blood pressure in overweight schoolchildren with metabolic syndrome.

    BACKGROUND: This study sought to investigate the effects of omega (ω)-3 polyunsaturated fatty acid (PUFA) supplementation on the lipid profiles and glucose (GLU) levels of overweight (OW) schoolchildren with metabolic syndrome (MS).

    METHODS: Thirty-nine OW schoolchildren with MS, including 19 girls and 20 boys, received 1-month of dietary supplementation with gel capsules containing ω-3 fatty acids. Fasting lipid profiles and GLU levels were measured before and after supplementation.

    RESULTS: Both sexes of OW schoolchildren with MS who received daily supplementation with 2.4 g of ω-3 fatty acids for 1 month displayed improved lipid profiles, reduced fasting GLU levels and reduced blood pressure (BP).

    CONCLUSIONS: These findings support the addition of omega-3 fatty acid supplementation to programs aiming to improve the metabolic status of OW children with MS, although additional research on the longer-term safety and efficacy of this treatment in this population is required.

    Be well!

    JP

  9. JP Says:

    Updated 05/02/17:

    https://www.ncbi.nlm.nih.gov/pubmed/28459647

    J Med Food. 2017 May 1.

    Effect of Gymnema sylvestre Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion.

    Gymnema sylvestre is a medicinal plant whose consumption has demonstrated benefits on lipid and glucose levels, blood pressure, and body weight (BWt). The aim of this study was to evaluate the effect of G. sylvestre administration on metabolic syndrome (MetS), insulin secretion, and insulin sensitivity. A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients (without pharmacological treatment), 30-60 years old, with diagnosis of MetS in accordance with the modified International Diabetes Federation criteria. Patients were randomly assigned to receive G. sylvestre or placebo twice daily before breakfast and dinner in 300 mg capsules for a total of 600 mg per day for 12 weeks. Before and after the intervention, the components of MetS were evaluated as well as BWt, body mass index (BMI), total cholesterol, low-density lipoprotein cholesterol, and very low-density lipoprotein (VLDL). Area under the curve of glucose and insulin, phases of insulin secretion, and insulin sensitivity were calculated. Statistical analysis was performed using Wilcoxon signed-rank, Mann-Whitney U, and chi-square tests; P ≤ .05 was considered statistically significant. After G. sylvestre administration, significant decreases in BWt (81.3 ± 10.6 kg vs. 77.9 ± 8.4 kg, P = .02), BMI (31.2 ± 2.5 kg/m2 vs. 30.4 ± 2.2 kg/m2, P = .02), and VLDL levels (0.45 ± 0.15 mmol/dL vs. 0.35 ± 0.15 mmol/dL, P = .05) were observed, without modifying the components of MetS, insulin secretion, and insulin sensitivity. In conclusion, G. sylvestre administration decreased BWt, BMI, and VLDL levels in subjects with MetS, without changes in insulin secretion and insulin sensitivity.

    Be well!

    JP

  10. JP Says:

    Updated 06/12/17:

    http://online.liebertpub.com/doi/10.1089/jmf.2017.0003

    J Med Food. 2017 Jun 9.

    Effect of Ursolic Acid on Metabolic Syndrome, Insulin Sensitivity, and Inflammation.

    To evaluate the effect of ursolic acid on metabolic syndrome, insulin sensitivity, and inflammation. A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients (30-60 years) with a diagnosis of metabolic syndrome without treatment. They were randomly assigned to two groups of 12 patients, each to receive orally 150 mg of ursolic acid or homologated placebo once a day for 12 weeks. Before and after the intervention, the components of metabolic syndrome, insulin sensitivity (Matsuda index), and inflammation profile (interleukin-6 and C-reactive protein) were evaluated. After ursolic acid administration, the remission of metabolic syndrome occurred in 50% of patients (P = .005) with significant differences in body weight (75.7 ± 11.5 vs. 71 ± 11 kg, P = .002), body mass index (BMI) (29.9 + 3.6 vs. 24.9 ± 1.2 kg/m2, P = .049), waist circumference (93 ± 8.9 vs. 83 + 8.6 cm, P = .008), fasting glucose (6.0 ± 0.5 vs. 4.7 ± 0.4 mmol/L, P = .002), and insulin sensitivity (3.1 ± 1.1 vs. 4.2 ± 1.2, P = .003). Ursolic acid administration leads to transient remission of metabolic syndrome, reducing body weight, BMI, waist circumference and fasting glucose, as well as increasing insulin sensitivity.

    Be well!

    JP

  11. JP Says:

    Updated 12/06/17:

    http://onlinelibrary.wiley.com/doi/10.1111/sms.13029/abstract

    Scand J Med Sci Sports. 2017 Dec 5.

    Yoga training modulates adipokines in adults with high-normal blood pressure and metabolic syndrome.

    OBJECTIVES: Metabolic syndrome (MetS) is associated with diabetes mellitus and cardiovascular diseases. Our previous study indicated that people with MetS showed a decrease in waist circumference and a decreasing trend in blood pressure after 1 year of yoga. This study investigated the effect of yoga on MetS people with high-normal blood pressure by exploring modulations in pro-inflammatory adipokines (leptin, chemerin, visfatin and plasminogen activator inhibitor-1 or PAI-1) and an anti-inflammatory adipokine (adiponectin).

    DESIGN & METHODS: A total of 97 Hong Kong Chinese individuals aged 57.6 ± 9.1 years with MetS and high-normal blood pressure were randomly assigned to control (n = 45) and yoga groups (n = 52). Participants in the control group were not given any intervention but were contacted monthly to monitor their health status. Participants in the yoga group underwent a yoga training programme with three 1-hour yoga sessions weekly for 1 year. The participants’ sera were harvested and assessed for adipokines. Generalized estimating equation (GEE) was used to examine the interaction effect between 1 year of time (pre vs. post) and intervention (control vs. yoga).

    RESULTS: GEE analyses revealed significant interaction effects between 1-year of time and yoga intervention for the decreases in leptin and chemerin and the increase in adiponectin concentration in the sera examined.

    CONCLUSION: These results demonstrated that 1 year of yoga training decreased pro-inflammatory adipokines and increased anti-inflammatory adipokine in adults with MetS and high-normal blood pressure. These findings support the beneficial role of yoga in managing MetS by favourably modulating adipokines.

    Be well!

    JP

  12. JP Says:

    Updated 1/18/18:

    http://online.liebertpub.com/doi/10.1089/jmf.2017.0092

    J Med Food. 2018 Jan 16.

    Effect of Irvingia gabonensis on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion.

    The aim of this study was to evaluate the effect of Irvingia gabonensis on metabolic syndrome (MetS), insulin sensitivity, and insulin secretion. A randomized, double-blind, placebo-controlled clinical trial was performed in 24 patients with MetS in accordance with the International Diabetes Federation criteria. Twelve patients received I. gabonensis (150 mg) twice a day during 90 days, and 12 patients received placebo. Glucose and insulin concentrations were measured during a 2-h oral glucose tolerance test. Also, lipid profile, creatinine, uric acid, and hepatic enzymes were determined. The area under the curve (AUC) of glucose and insulin, total insulin secretion, first phase of insulin secretion, and insulin sensitivity were calculated. Data were tested using non-parametric tests. The Ethics Committee approved the protocol. After I. gabonensis administration, significant decreases in waist circumference (WC) (94.0 ± 8.0 vs. 91.0 ± 8.2 cm, P < .01), glucose 90′ (10.0 ± 2.5 vs. 8.6 ± 2.7 mmol/L, P < .05), glucose 120′ (8.8 ± 2.4 vs. 7.6 ± 2.7 mmol/L, P < .05), triglycerides (2.5 ± 1.2 vs. 2.0 ± 1.1 mmol/L, P < .05), very low-density lipoproteins (VLDL) (0.5 ± 0.2 vs. 0.4 ± 0.2 mmol/L, P < .05), and AUC of glucose (694 ± 142 vs. 629 ± 172 mmol/L/min, P < .05) were found. Seven patients (58.3%) of the I. gabonensis group showed remission of MetS and two patients (16.7%) of the placebo group (P = .045). I. gabonensis lead to remission of MetS in 58.3% of the patients and significantly decreased WC, glucose 90′, glucose 120′, triglycerides, VLDL, and AUC of glucose.

    Be well!

    JP

  13. JP Says:

    Updated 10/27/18:

    https://www.ncbi.nlm.nih.gov/pubmed/30362336

    Asian Pac J Cancer Prev. 2018 Oct 26;19(10):2979-2984.

    The Effect of Gluten Free Diet on Components of Metabolic Syndrome: A Randomized Clinical Trial

    BACKGROUND: This study aimed to assess the effects of Gluten free diet (GFD) on components of metabolic syndrome (MES).

    MATERIALS AND METHODS: In this randomized clinical trial, 50 subjects diagnosed with MES were randomly divided into two groups (n=25). The first group received a GFD and the second group continued their regular diet. Biochemical markers of MES and blood pressure were measured before and after 8-week intervention.

    RESULTS: Forty five subjects completed the study. A post-hoc comparison of the groups showed no effects of the GFD and control diet on LDL cholesterol, total cholesterol, fasting insulin, HOMA-IR, systolic and diastolic blood pressure levels. The GFD reduced fasting blood glucose, waist circumference (WC) and serum triglyceride concentration significantly compared with the control diet (p<0.05).

    CONCLUSION: Short-term GFD reduced WC and improved glycemic control and Triglyceride level in subjects with the metabolic syndrome.

    Be well!

    JP

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