1.
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
-
-
-
Free full text
Plain language summary
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).
2.
Effects of n-3 fatty acids and exercise on oxidative stress parameters in type 2 diabetic: a randomized clinical trial.
Fayh, APT, Borges, K, Cunha, GS, Krause, M, Rocha, R, de Bittencourt, PIH, Moreira, JCF, Friedman, R, da Silva Rossato, J, Fernandes, JR, et al
Journal of the International Society of Sports Nutrition. 2018;15:18
-
-
-
Free full text
Plain language summary
An elevated blood glucose level is one of the key metabolic abnormalities associated with complications in type 2 diabetes. Literature shows that individuals with type 2 diabetes have higher inflammatory levels than those with normal blood glucose tolerance. The aim of this study was to examine if omega-3 polyunsaturated fatty acid (PUFA) supplementation can reduce the inflammatory response associated with high-intensity exercise in type 2 diabetic individuals. This was a randomised, double-blind controlled study, which recruited 30 type 2 diabetic men and women aged between 30 and 60 years. Results indicate that after 8 weeks, omega-3 PUFA supplementation diminished the concentration of the total reactive antioxidant potential and triglyceride levels after high intensity exercise, however did not reduce the inflammatory response.
Abstract
BACKGROUND The relationship between diabetes and oxidative stress has been previously reported. Exercise represents a useful non-pharmacological strategy for the treatment in type 2 diabetic (T2DM) patients, but high intensity exercise can induce a transient inflammatory state and increase oxidative stress. Nutritional strategies that may contribute to the reduction of oxidative stress induced by acute exercise are necessary. The aim of this study was to examine if n-3 PUFA supplementation intervention can attenuate the inflammatory response and oxidative stress associated with high intensity exercise in this population. As a primary outcome, lipoperoxidation measurements (TBARS and F2-isoprostanes) were selected. METHODS Thirty T2DM patients, without chronic complications, were randomly allocated into two groups: placebo (gelatin capsules) or n-3 PUFA (capsules containing 180 mg of eicosapentaenoic acid and 120 mg of docosahexaenoic acid). Blood samples were collected fasting before and after 8 weeks supplementation. In the beginning and at the end of protocol, an acute exercise was performed (treadmill), and new blood samples were collected before and immediately after the exercise for measurements of oxidative stress and high-sensitivity C-reactive protein (hs-CRP). RESULTS After the supplementation period, a decrease in triglycerides levels was observed only in n-3 PUFA supplementation group (mean difference and 95% CI of 0.002 (0.000-0.004), p = 0.005). Supplementation also significantly reduced TRAP levels after exercise (mean difference and 95% CI to 9641 (- 20,068-39,351) for - 33,884 (- 56,976 - -10,793), p = 0.004, Cohen's d effect size = 1.12), but no significant difference was observed in n-3 PUFA supplementation group in lipoperoxidation parameters as TBARS (mean difference and 95% CI to - 3.8 (- 10-2.4) for - 2.9 (- 1.6-7.4) or F2-isoprostanes (mean difference and 95% CI -0.05 (- 0.19-0.10) for - 0.02 (- 0.19-0.16), p > 0.05 for both. CONCLUSION PUFA n-3 supplementation reduced triglycerides as well as TRAP levels after exercise, without a significant effect on inflammatory and oxidative stress markers.This study is registered at ClinicalTrials.gov with the registration number of NCT03182712.
3.
Cardiovascular Biomarkers in Association with Dietary Intake in a Longitudinal Study of Youth with Type 1 Diabetes.
Sanjeevi, N, Lipsky, LM, Nansel, TR
Nutrients. 2018;10(10)
-
-
-
Free full text
Plain language summary
Cardiovascular disease (CVD) is the major cause of mortality and morbidity in patients with type 1 diabetes, whose risk is several-fold higher than the general population. The objective of this study was to investigate relationships of CVD biomarkers with overall diet quality, and its dietary components in youth with type 1 diabetes. This study is a secondary analysis of a randomised controlled trial of a family-based behavioural nutrition intervention. The control group had an equal frequency of contact with the research staff but did not receive any nutrition advice besides that included as part of regular type 1 diabetes care. Results indicate that greater intake of whole grains and whole fruits, and lower added sugar and polyunsaturated fatty acids were associated with more favourable CVD biomarkers. Authors conclude that overall diet quality was not associated with CVD biomarkers in youth with type 1 diabetes. However, specific dietary components were associated with CVD biomarkers, independent of glycaemic control.
Abstract
Despite cardioprotective effects of a healthy diet in the general population, few studies have investigated this relationship in individuals with type 1 diabetes, who are at elevated risks of cardiovascular disease (CVD) due to hyperglycemia. The objective of this study was to examine the association of CVD biomarkers with overall diet quality, as measured by the Healthy Eating Index-2015 (HEI-2015), and its dietary components in youth with type 1 diabetes. Youth with type 1 diabetes (n = 136, 8⁻16.9 years) were enrolled in an 18-month behavioral nutrition intervention trial. Dietary intake from three-day diet records, CVD biomarkers (total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C); triglycerides (TG), C-reactive protein (CRP), 8-iso-prostaglandin-F2alpha (8-iso-PGF2α), systolic and diastolic blood pressure (SBP and DBP, respectively), and glycated hemoglobin (HbA1c) were assessed at baseline, 6, 12 and 18 months. Linear mixed-effects models estimated associations of dietary intake with CVD biomarkers, adjusting for HbA1c and other covariates. Separate models estimated associations of time-varying change in dietary intake with time-varying change in CVD biomarkers. HEI-2015 was not associated with CVD biomarkers, but whole grain intake was inversely associated with TC, HDL-C and DBP, and a greater increase in whole fruit intake was associated with lower DBP. Added sugar, saturated fat and polyunsaturated fat were positively related to serum TG, HDL-C, and DBP, respectively. Findings suggest that the intake of specific dietary components, including whole grains, whole fruits, added sugar and PUFA, may influence cardiometabolic health in youth with type 1 diabetes, independent of glycemic control.