Garlic supplementation improves intestinal transit time, lipid accumulation product and cardiometabolic indices in subjects with metabolic syndrome: A randomized controlled trial.

Subjects with metabolic syndrome (MetS) are at increased risk for cardiovascular disease (CVD). Altered gut microbiota is involved in the pathogenesis of MetS. It has been hypothesized that garlic can improve intestinal transit time and cardiovascular risks. We investigated the effect of garlic powder supplementation on intestinal transit time, lipid accumulation product (LAP), and cardiometabolic indices in subjects with MetS. A double-blind randomized controlled trial was conducted for 3 months among subjects with MetS. Ninety subjects were randomly assigned to the treatment group (intake of 1,600 mg/d garlic powder) or control group (placebo) using a computer-generated random number table. All participants were asked to follow the common healthy dietary recommendations during follow-up. The primary outcomes included intestinal transit time, LAP, cardiometabolic index (CMI), atherogenic index of plasma (AIP), Castelli risk index I (CRI-I) and Castelli risk index II (CRI-II). Garlic powder compared to the placebo improved intestinal transit time (p = .001), LAP (-21.5 ± 23.4 vs. 0.7 ± 21.5; p < .001), CMI (-0.85 ± 0.8 vs. 0.13 ± 0.8; p < .001), AIP (-0.14 ± 0.1 vs. 0.01 ± 0.1; p < .001), CRI-I (-0.69 ± 0.5 vs. 0.16 ± 0.5; p < .001) and CRI-II (-0.50 ± 0.3 vs. 0.02 ± 0.3; p < .001). Garlic supplementation can improve intestinal transit time, LAP, and cardiometabolic indices.

Effects of curcumin and/or coenzyme Q10 supplementation on metabolic control in subjects with metabolic syndrome: a randomized clinical trial.

BACKGROUND: Metabolic syndrome (MetS) as a cluster of conditions including hyperlipidemia, hypertension, hyperglycemia, insulin resistance, and abdominal obesity is linked to cardiovascular diseases and type 2 diabetes. Evidence suggested that intake of curcumin and coenzyme Q10 may have therapeutic effects in the management of MetS. AIMS: We investigated the effects of curcumin and/or coenzyme Q10 supplementation on metabolic syndrome components including systolic blood pressure (SBP), diastolic blood pressure (DBP), waist circumference (WC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-c) and fasting plasma glucose (FPG) as primary outcomes, and total cholesterol (TC), low density lipoprotein-cholesterol (LDL-c) and body mass index (BMI) as secondary outcomes in subjects with MetS. METHODS: In this 2 × 2 factorial, randomized, double-blinded, placebo-controlled study, 88 subjects with MetS were randomly assigned into four groups including curcumin plus placebo (CP), or coenzyme Q10 plus placebo (QP), or curcumin plus coenzyme Q10 (CQ), or double placebo (DP) for 12 weeks. RESULTS: The CP group compared with the three other groups showed a significant reduction in HDL-c (P = 0.001), TG (P <  0.001), TC (P <  0.001), and LDL-c (P <  0.001). No significant differences were seen between the four groups in terms of SBP, DBP, FPG, WC, BMI and weight. CONCLUSION: Curcumin improved dyslipidemia, but had no effect on body composition, hypertension and glycemic control. Furthermore, coenzyme Q10 as well as the combination of curcumin and coenzyme Q10 showed no therapeutic effects in subjects with MetS. The trial was registered on 09/21/2018 at the Iranian clinical trials website (IRCT20180201038585N2), URL: https://www.irct.ir/trial/32518 .

Effect of vitamin D supplementation on brain waves, behavioral performance, nitric oxide, malondialdehyde, and high-sensitivity C-reactive protein in children with attention deficit/hyperactivity disorder: study protocol for a randomized clinical trial.

BACKGROUND: Attention deficit/hyperactivity disorder (ADHD) is the most common chronic mental and behavioral disorder among children. Some studies showed the lower levels of vitamin D in patients with ADHD compared with the healthy people. Few clinical trials were conducted in this field. The present study will be performed to examine the effect of vitamin D supplementation in children with ADHD. METHODS: We will conduct a double-blind, randomized controlled clinical trial to investigate the effect of vitamin D supplementation on brain waves, behavioral performance, serum nitric oxide, malondialdehyde, and high-sensitivity C-reactive protein in 50 patients with ADHD. The intervention group will receive one capsule 50,000 IU vitamin D every week, for 8 weeks. The control group will receive one placebo capsule containing 1000 mg olive oil every week. Electroencephalography will be performed for 10 min using Brain Master Discovery from 19 scalp sites both before the first intervention and the 10 sessions of the therapy. The artifact-free periods of 1-min electroencephalography data will be analyzed for quantitative electroencephalography measures. DISCUSSION: For the first time, this clinical trial will evaluate the effect of vitamin D supplementation on brain waves, serum nitric oxide, malondialdehyde, and high-sensitivity C-reactive protein in patients with ADHD. The results of the present clinical trial will provide a better vision about the vitamin D efficacy in patients with ADHD. TRIAL REGISTRATION: Registered on 5 November 2020 at Iranian Registry of Clinical Trials with code number IRCT20200922048802N1 ( https://www.irct.ir/trial/51410 ).

Effect of L-carnitine supplementation on lipid accumulation product and cardiovascular indices in women with overweight/obesity who have knee osteoarthritis: a randomized controlled trial.

BACKGROUND: Osteoarthritis is associated with obesity, dyslipidemia and cardiovascular diseases. It has been hypothesized that L-carnitine can improve cardiovascular risk factors. We aimed to investigate the effect of L-carnitine supplementation on lipid accumulation product (LAP) and atherogenic indices in women with overweight/obesity who have knee osteoarthritis. METHODS: In this double-blind randomized controlled trial, seventy-six women with overweight/obesity who had knee osteoarthritis were assigned into the intervention group and control group for 12 weeks. The intervention group received 1000 mg/day L-carnitine as capsule, and the control group received placebo. The primary outcomes were LAP, atherogenic index of plasma (AIP), atherogenic coefficient (AC) and Castelli risk index II (CRI-II). RESULTS: We found no significant difference between the groups in baseline values of LAP, AIP, AC and CRI-II. After the intervention, a significant reduction in LAP was observed in intervention group compared to the control group (- 11.05 (- 28.24 to 0.40) vs. - 5.82 (- 24.44 to 2.68); P = 0.03). However, there was no significant difference between two groups in AIP (- 0.05 ± 0.16 vs. - 0.01 ± 0.13; P = 0.19), AC (- 0.40 ± 0.81 vs. - 0.30 ± 0.67; P = 0.67) and CRI-II (- 0.20 ± 0.76 vs. - 0.21 ± 0.47; P = 0.11). CONCLUSIONS: L-carnitine supplementation for 12 weeks can improve LAP, but it has no effect on cardiovascular outcomes. To reach a definitive conclusion, further clinical trials with larger sample sizes and higher dosages of L-carnitine are needed. TRIAL REGISTRATION: Registered on 27/4/2017 at Iranian Registry of Clinical Trials IRCT2017011932026N2.

Effect of Cornus mas L. fruit extract on lipid accumulation product and cardiovascular indices in patients with non-alcoholic fatty liver disease: A double-blind randomized controlled trial.

BACKGROUND & AIMS: Non-alcoholic fatty liver disease (NAFLD) is associated with high risk of cardiovascular diseases. The experimental studies have suggested that Cornus mas L. (cornelian cherry) fruit can improve cardiovascular risk factors. We designed a study to investigate the effect of cornelian cherry fruit extract on cardiovascular outcomes in patients with NAFLD. METHODS: We conducted a double-blind, randomized controlled trial. Fifty patients with NAFLD were randomly assigned into the treatment and the control groups. The treatment group received 20 cc/d cornelian cherry fruit extract as liquid form and the control group received 20 cc/d placebo for 12 weeks. The primary outcomes included lipid accumulation product (LAP), atherogenic index of plasma (AIP), Castelli risk index I (CRI-I), CRI-II and atherogenic coefficient (AC). RESULTS: At the baseline, there was no significant difference between two groups in values of LAP, AIP, CRI-I, CRI-II and AC. After the intervention, no significant change was found in the treatment group compared to the control group in LAP (-0.64 (-6.25 to 8.29) vs. 0.0 (-8.66 to 19.01); P = 0.91), AIP (0.0 ± 0.08 vs. 0.0 ± 0.1; P = 0.84), CRI-I (-0.18 ± 0.63 vs. -0.31 ± 0.49; P = 0.42), CRI-II (-0.23 ± 0.56 vs. -0.15 ± 0.32; P = 0.52) and AC (-0.18 ± 0.63 vs. -0.31 ± 0.49; P = 0.42). CONCLUSION: Cornelian cherry fruit extract has no effect on cardiovascular outcomes. Further studies with longer intervention durations are needed. TRIAL REGISTRATION: Registered on 30 September 2018 at Iranian Registry of Clinical Trials (IRCT20180419039359N1).

The effect of L-carnitine supplementation on insulin resistance, sex hormone-binding globulin and lipid profile in overweight/obese women with polycystic ovary syndrome: a randomized clinical trial.

PURPOSE: Polycystic ovary syndrome (PCOS) is a common endocrine disorder among reproductive-age women. Insulin resistance and dyslipidemia are linked to PCOS. L-Carnitine supplementation as a management strategy for women with PCOS has been proposed. The effect of L-carnitine supplementation on insulin resistance, sex hormone-binding globulin (SHBG) and lipid profile in overweight/obese women with PCOS was investigated. METHODS: This randomized, double-blind, controlled clinical trial, was conducted on 62overweight/obese women with PCOS. Participants were randomly assigned into two groups to receive 1000 mg/day L-carnitine or placebo (1000 mg starch) for 12 weeks. RESULTS: L-Carnitine supplementation compared to the placebo showed a significant improvement in insulin [- 0.7 (- 7.3 to 4.0) vs. 0.7 (- 3.0 to 5.2); P = 0.001], homeostatic model assessment for insulin resistance [- 0.4 (- 1.7 to 1.1) vs. 0.0 (- 0.7 to 1.3); P = 0.002], quantitative insulin sensitivity check index (+ 0.01 ± 0.02 vs. - 0.01 ± 0.01; P = 0.02) and a non-significant change toward improvement in SHBG (+ 11.5 ± 40.2 vs. - 3.2 ± 40.2; P = 0.2). However, there was no significant differences between the two groups in serum levels of fasting plasma glucose, total cholesterol, triglyceride, low density lipoprotein-cholesterol and high density lipoprotein cholesterol (P > 0.05). CONCLUSION: 12-week L-carnitine supplementation in overweight or obese women with PCOS ameliorate insulin resistance, but has no effect on SHBG and lipid profile. Studies with higher dosages and duration of L-carnitine intake are required. The trial was registered on 30 December 2019 at Iranian Registry of Clinical Trials IRCT20191016045131N1. TRIAL REGISTRATION: Registered on 30th December 2019 at Iranian Registry of Clinical Trials (IRCT20191016045131N1).

Effect of omega-3 supplementation on cardiometabolic indices in diabetic patients with non-alcoholic fatty liver disease: a randomized controlled trial.

BACKGROUND: Patients with non-alcoholic fatty liver disease (NAFLD) as well as type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular diseases (CVD). Omega-3 supplementation has been proposed as a possible strategy for management of cardiometabolic risk. Cardiometabolic indices can predict and evaluate the cardiometabolic risk. AIMS: We investigated the effect of omega-3 supplementation on accurate and available cardiometabolic indices including atherogenic index of plasma (AIP), Castelli risk index I, Castelli risk index II and atherogenic coefficient (AC) in diabetic patients with NAFLD. METHODS: We conducted a double-blind, randomized controlled trial (RCT) for 12 weeks. From August 2016 to March 2017, the subjects referred to Faghihi hospital in Shiraz, Iran, were recruited. Sixty diabetic patients with NAFLD were randomly assigned into the omega-3 (2000 mg/d omega-3 capsule contained 360 mg/d eicosapentaenoic acid and 240 mg/d docosahexaenoic acid) and the placebo (liquid paraffin) groups using computer-generated random number table. RESULTS: Omega-3 supplementation compared to the placebo had no significant effect on AIP (- 0.11 ± 0.20 vs. -0.03 ± 0.16; P = 0.11), Castelli risk index I (- 0.25 ± 0.6 vs. -0.07 ± 0.7; P = 0.42), Castelli risk index II (- 0.24 ± 0.5 vs. -0.14 ± 0.5; P = 0.63) and AC (- 0.25 ± 0.6 vs. -0.07 ± 0.7; P = 0.42). After adjusting for confounding factors, the findings remained without change. CONCLUSION: Omega-3 supplementation (2000 mg/d) for 12 weeks has no effect on cardiometabolic risk. It seems, higher doses of omega-3 can improve cordiometabolic risk. The trial was registered at Iranian Registry of Clinical Trials IRCT2016102530489N1.

Effect of l-carnitine supplementation on liver fat content and cardiometabolic indices in overweight/obese women with polycystic ovary syndrome: A randomized controlled trial.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a common endocrine disorder among reproductive-age women, and is associated with cardiovascular diseases as well as non-alcoholic fatty liver disease. The recent evidence suggested the beneficial effects of l-carnitine in women with PCOS. OBJECTIVE: The present study aimed to investigate the effect of l-carnitine supplementation on liver fat content and cardiometabolic outcomes in overweight/obese women with PCOS. METHODS: The present study was designed as a 12-week double-blind, randomized controlled clinical trial. Sixty-two overweight/obese women with PCOS were assigned into the treatment (received 1000 mg/d l-carnitine capsule) and the control (received placebo capsule) groups. The outcomes included lipid accumulation product (LAP), atherogenic index of plasma (AIP), atherogenic coefficient (AC) and Castelli II indices. RESULTS: At the end of the trial, there was no significant difference between the treatment and the control groups in terms of LAP (-1.1 vs. -4.0; P = 0.45), AIP (0.0 vs. -0.09; P = 0.14), AC (-0.2 vs. -0.8; P = 0.06) and Castelli II index (-0.2 vs. -0.6; P = 0.07) after controlling the mean change of waist circumference. CONCLUSION: l-carnitine supplementation for 12 weeks has no beneficial effect on liver fat content and cardiometabolic outcomes in overweight or obese women with PCOS. TRIAL REGISTRATION: Registered on 30 December 2019 at Iranian Registry of Clinical Trials IRCT20191016045131N1.

Effect of omega-3 supplementation on fatty liver and visceral adiposity indices in diabetic patients with non-alcoholic fatty liver disease: A randomized controlled trial.

BACKGROUND AND AIMS: Non-alcoholic fatty liver disease (NAFLD) as the most common chronic liver disease is closely linked to type 2 diabetes mellitus (T2DM). Omega-3 supplementation has been proposed as a strategy to manage T2DM and NAFLD. The present study aimed to investigate the effect of omega-3 supplementation on fatty liver index, lipid accumulation product and visceral adiposity index in diabetic patients with NAFLD. METHODS: In this 12-week double-blind, randomized controlled clinical trial, sixty diabetic patients with NAFLD were randomly assigned into the omega-3 and placebo groups for 12 weeks. The omega-3 group received 2000 mg/d omega-3 as capsule. RESULTS: Fifty-six participants completed the study. No significant difference was found between the two groups in the terms of fatty liver index, lipid accumulation product and visceral adiposity index at the baseline. Omega-3 supplementation compared with the placebo led to a significant improvement in fatty liver index (-3.6 ± 12.1 vs. 0.9 ± 8.9; P = 0.04), lipid accumulation product (-14.2 ± 27.9 vs. 8.0 ± 26.3; P = 0.002) and visceral adiposity index (-0.5 ± 0.9 vs. 0.0 ± 0.8; P = 0.01). CONCLUSION: Omega-3 supplementation for 12 weeks improves fatty liver index, lipid accumulation product and visceral adiposity index. The study protocol was registered under Iranian Registry of Clinical Trials identifier number IRCT2016102530489N1.

Effects of garlic powder supplementation on metabolic syndrome components, insulin resistance, fatty liver index, and appetite in subjects with metabolic syndrome: A randomized clinical trial.

The prevalence of metabolic syndrome (MetS) is increasing. It is closely linked to nonalcoholic fatty liver disease. Garlic consumption as a strategy for the management of MetS has been suggested. We investigated the effect of garlic supplementation on MetS components, insulin resistance, fatty liver index (FLI), and appetite in subjects with MetS. Ninety subjects were assigned to receive 1,600 mg/d garlic powder or placebo for 3 months. The primary outcomes included MetS components. The secondary outcomes included insulin resistance, FLI, and appetite. Garlic supplementation compared with the placebo led to a significant increase in high density lipoprotein-cholesterol (4.5 vs. -1.8, p < .001) and a significant reduction in waist circumference (-1.3 vs. 0.0, p = .001), diastolic blood pressure (-6.7 vs. 0.0, p < .001), systolic blood pressure (-7.7 vs. 0.5, p < .001), triglyceride (-40.0 vs. 0.1, p < .001), γ-glutamyl transferase (-3.2 vs. 0.6, p = .01), FLI (-5.5 vs. 0.1, p < .001), insulin (-2.9 vs. -1.1, p < .001), homeostatic model of assessment for insulin resistance (-0.5 vs. -0.3, p < .001) and appetite (hunger: -11.7 vs. 1.7, p < .001; fullness: 10.0 vs. 0.3, p = .001; desire to eat: -6.7 vs. 2.1, p < .001; and ability to eat: -11.5 vs. -1.0, p < .001). Garlic improves MetS components, insulin resistance, FLI, and appetite.

Effects of garlic powder supplementation on insulin resistance, oxidative stress, and body composition in patients with non-alcoholic fatty liver disease: A randomized controlled clinical trial.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Insulin resistance, oxidative stress, and obesity are major contributors to NAFLD pathogenesis. The effects of garlic powder supplementation on these risk factors in patients with NAFLD was investigated. METHODS: In this 12-wk, randomized controlled clinical trial, ninety patients with NAFLD were randomly assigned to two groups. The treatment group received four tablets of garlic (each coated tablet contained 400 mg garlic powder) daily and the control group received four tablets of placebo (each coated tablet contained 400 mg starch). RESULTS: A significant decrease was seen in the treatment group compared to the control group in waist circumference (P = 0.001), body fat percent (P < 0.001), serum concentration of fasting blood sugar (P = 0.01), insulin (P < 0.001), homeostatic model assessment for insulin resistance (P < 0.001), and malondialdehyde (P < 0.001), as well as significant increase in skeletal muscle mass (P = 0.002), serum concentration of superoxide dismutase (P < 0.001), and total antioxidant capacity (P < 0.001). CONCLUSION: Garlic powder supplementation improved risk factors of NAFLD. Further studies are needed to determine the effects of garlic on hepatic features in patients with NAFLD. The study protocol was registered at Iranian clinical trials website under code IRCT20170206032417N4.

Effect of garlic powder supplementation on hepatic steatosis, liver enzymes and lipid profile in patients with non-alcoholic fatty liver disease: a double-blind randomised controlled clinical trial.

Non-alcoholic fatty liver disease (NAFLD) includes a range of disorders from simple steatosis to non-alcoholic steatohepatitis. There is no proven drug treatment for NAFLD, and diet modification is considered part of the main line of treatment for this disease. The aim of this study was to investigate the efficacy of garlic supplementation in NAFLD patients. The effect of garlic powder supplementation on hepatic steatosis, liver enzymes and lipid profile was investigated in NAFLD patients. Ninety NAFLD patients were randomly assigned to take either a garlic powder supplement or a placebo for 12 weeks. The treatment group received four tablets of garlic daily (each tablet contained 400 mg garlic powder). The control group received four tablets of placebo (each placebo contained 400 mg starch). At the end of the study, hepatic steatosis was significantly reduced in the treatment group compared with the control group (P = 0·001). In addition, a significant decrease was seen in the serum concentration of alanine transaminase (P < 0·001), aspartate transaminase (P = 0·002), γ-glutamyltransferase (P = 0·003) as well as total cholesterol (P = 0·009), TAG (P < 0·001), HDL-cholesterol (P < 0·001) and LDL-cholesterol (P = 0·01) in the treatment group compared with the control group. No significant difference was seen between the two groups in serum concentration of alkaline phosphatase. Overall, garlic powder supplementation improved hepatic features and lipid profile among NAFLD patients.

A narrative review on effects of vitamin D on main risk factors and severity of Non-Alcoholic Fatty Liver Disease.

The global prevalence of Non-alcoholic fatty liver disease (NAFLD) is increasing rapidly. Many studies have been conducted on the treatment of NAFLD; nevertheless, there is still no approved drug treatment for this disease. Although the pathogenesis of NAFLD is not fully understood, but inflammation, insulin resistance, oxidative stress, obesity and dyslipidemia are among the main causes. Epidemiological studies have shown that hypovitaminosis D is associated with these factors causing NAFLD. In addition, rate of Vitamin D deficiency has been shown to be directly related to the severity of NAFLD. Accordingly, it is believed that vitamin D may help to treatment of NAFLD by improving the above-mentioned risk factors. The purpose of this review is to survey the recent advances in the field of Vitamin D efficacy on risk factors and the severity of NAFLD based on existing evidence, especially the clinical efficiency of vitamin D supplementation in patients with NAFLD.