Ameliorating effects of L-carnitine and synbiotic co-supplementation on anthropometric measures and cardiometabolic traits in women with obesity: a randomized controlled clinical trial.

Background: Obesity, a multifactorial disorder with pandemic dimensions, is conceded a major culprit of morbidity and mortality worldwide, necessitating efficient therapeutic strategies. Nutraceuticals and functional foods are considered promising adjuvant/complementary approaches for weight management in individuals with obesity who have low adherence to conventional treatments. Current literature supports the weight-reducing efficacy of pro/pre/synbiotics or L-carnitine; however, the superiority of the nutraceutical joint supplementation approach over common single therapies to counter obesity and accompanying comorbidities is well documented. This study was designed to assess the effects of L-carnitine single therapy compared with L-carnitine and multistrain/multispecies synbiotic co-supplementation on anthropometric and cardiometabolic indicators in women with obesity. Methods: The current placebo-controlled double-blind randomized clinical trial was performed on 46 women with obesity, randomly allocated to either concomitant supplementation [L-carnitine tartrate (2 × 500 mg/day) + multistrain/multispecies synbiotic (1 capsule/day)] or monotherapy [L-carnitine tartrate (2 × 500 mg/day) + maltodextrin (1 capsule/day)] groups for 8 weeks. Participants in both groups received healthy eating dietary advice. Results: Anthropometric, lipid, and glycemic indices significantly improved in both intervention groups; however, L-carnitine + synbiotic co-administration elicited a greater reduction in the anthropometric measures including body mass index (BMI), body weight, and neck, waist, and hip circumferences (p < 0.001, <0.001, <0.001, = 0.012, and =0.030, respectively) after adjusting for probable confounders. Moreover, L-carnitine + synbiotic joint supplementation resulted in a greater reduction in fasting blood sugar (FBS), insulin (though marginal), and homeostatic model assessment of insulin resistance (HOMA-IR) and more increment in quantitative insulin sensitivity check index (QUICKI; p = 0.014, 0.051, 0.024, and 0.019, respectively) compared with the L-carnitine + placebo monosupplementation. No significant intergroup changes were found for the lipid profile biomarkers, except for a greater increase in high-density lipoprotein-cholesterol concentrations (HDL-C) in the L-carnitine + synbiotic group (p = 0.009). Conclusion: L-carnitine + synbiotic co-supplementation was more beneficial in ameliorating anthropometric indices as well as some cardiometabolic parameters compared with L-carnitine single therapy, suggesting that it is a promising adjuvant approach to ameliorate obesity or associated metabolic complications through potential synergistic or complementary mechanisms. Further longer duration clinical trials in a three-group design are demanded to verify the complementary or synergistic mechanisms. Clinical trial registration: www.irct.ir, Iranian Registry of Clinical Trials IRCT20080904001197N13.

L-Carnitine and synbiotic co-supplementation: beneficial effects on metabolic-endotoxemia, meta-inflammation, and oxidative-stress biomarkers in obese patients: a double blind, randomized, controlled clinical trial.

Obesity, a chronic pandemic disease, is characterized by low-grade chronic inflammation, accompanied by over-expression of pro-inflammatory cytokines, thereby contributing to metabolic disorders pathogenesis. Oxidative-stress, an adverse cellular response to adipocyte hypertrophy, promotes inflammation. Furthermore, gut-microbiota dysbiosis may induce oxidative-stress, low-grade inflammation, and metabolic-endotoxemia as major drivers of obesity. Functional-foods/nutraceuticals have attracted extensive attention due to their plausible anti-inflammatory/anti-oxidative properties; evidence supports the superiority of the nutraceutical combined-supplementation approach versus conventional mono-therapies. Current data suggest the anti-oxidative/anti-inflammatory properties of either L-carnitine or pre/pro/synbiotics. This trial compared the effects of co-supplementing L-carnitine and multi-species/multi-strain synbiotic versusL-carnitine mono-therapy on inflammatory/anti-inflammatory, oxidative-stress, and metabolic-endotoxemia biomarkers in 46 female obese patients, receiving either co-supplementation (L-carnitine-tartrate (2 × 500 mg d-1) + multi-species/multi-strain synbiotic (1 capsule per day)) or mono-therapy (L-carnitine-tartrate (2 × 500 mg d-1) + maltodextrin (1 capsule per day)) for eight weeks. L-Carnitine + synbiotic co-supplementation significantly decreased interleukin-6 (IL-6, -33.98%), high-sensitivity-C-reactive-protein (hs-CRP, -10%), tumor-necrosis-factor-alpha (TNF-α, -18.73%), malondialdehyde (MDA, -21.73%), and lipopolysaccharide (LPS, -10.14%), whereas the increase in interleukin-10 (IL-10, 7.69%) and total-antioxidant-capacity (TAC, 4.13%) levels was not significant. No significant changes were observed for the above-mentioned parameters in the L-carnitine + placebo group, except for a significant reduction in IL-10 (-17.59%) and TNF-α (-14.78%); however, between-group differences did not reach the significant threshold. Co-supplementing L-carnitine + multi-strain synbiotic led to significant amelioration of inflammatory, oxidative, and metabolic-endotoxemia responses in female obese patients; nevertheless, no improving effects were observed in patients receiving single-supplementation, suggesting that L-carnitine + synbiotic co-supplementation might represent an adjuvant approach to improve oxidative-stress/pro-inflammatory indicators in women with obesity, possibly through beneficial effects of the synbiotic alone. Further longer duration studies with higher doses of L-carnitine in a three-group setting are warranted to elucidate the possibility of synergistic or complementary mechanisms.

The effects of olive oil and cholesterol enriched diets on aortic fatty streak development and lipid peroxidation in rabbits.

BACKGROUND AND AIM: High plasma cholesterol levels, mainly low-density lipoprotein-cholesterol (LDL) is a widely recognized major risk factor for coronary heart disease (CHD). According to epidemiologic studies' findings, people from the Mediterranean countries have lower CHD rates than other countries; in these countries the usual diet is high in olive oil. The present study compares the effects of a cholesterol-enriched diet with or without adding olive oil on serum lipoproteins, lipid peroxidation, and atherosclerosis development. METHODS: Twenty Dutch male rabbits were categorized into four groups (one group as control, and others as experimental). They received one of control (CON), olive oil-rich (OIL), cholesterol-rich (CHOL), and cholesterol + olive oil (COIL) diet for 12 weeks. Fasting blood samples from the heart were collected at the beginning and the end of the experimental period. RESULTS: Means of serum lipids were not significantly different at the beginning of the experimental period. After the intervention, significant differences were shown in total cholesterol (TC) (CON: 27.75 ± 4.83, OIL: 19.75 ± 2.62, CHOL: 1757.20 ± 149.62, COIL: 2906.40 ± 421.01; P < 0.001), high-density lipoprotein-cholesterol (HDL-C) (CON: 16 ± 1.47, OIL: 10.25 ± 1.70, CHOL: 22.2 ± 3.83, COIL: 28.60 ± 6.27; P = 0.04), triglyceride (CON: 65 ± 12.21, OIL: 71.75 ± 6.23, CHOL: 244.2 ± 44.45, COIL: 775.6 ± 105.07; P < 0.001), and MDA between groups (CON: 0.57 ± 0.10, OIL: 0.63 ± 0.15, CHOL: 5.62 ± 0.18, COIL: 2.06 ± 0.64; P < 0.001). The comparison of CHOL and the COIL groups showed a higher mean of malondialdehyde (MDA) in group CHOL (4.47 ± 0.28 vs 1.1 ± 0.6; P < 0.001). Aortic lesion was not observed in CON and OIL groups. Aortic lesion degree was significantly lower in the COIL group compared to the CHOL (2.4 ± 0.6 vs 3.66 ± 0.33; P = 0.02). CONCLUSIONS: These findings showed the preventive effect of olive oil on atherosclerosis development. However, it is independent of the plasma lipoprotein effect, and olive oil probably acts on arteries directly.

The impact of L-citrulline supplementation on glucose homeostasis, lipid profile, and some inflammatory factors in overweight and obese patients with type 2 diabetes: A double-blind randomized placebo-controlled trial.

This study investigated the impact of L-citrulline on glucose homeostasis, lipid profile, and inflammatory factors in overweight and obese patients with type 2 diabetes (T2D). In total, 54 participants with T2D were assigned to L-citrulline (3 g/day L-citrulline) or placebo groups and tested for 8 weeks. Serum levels of insulin, fasting glucose, hemoglobin A1c (HbA1c), lipid profile, tumor necrosis factor-α (TNF-α), high-sensitivity C-reactive protein (hs-CRP), and L-citrulline were measured pre- and post-intervention. Totally, 45 patients were enrolled in the research. L-citrulline supplementation decreased serum levels of insulin (p = .025), glucose (p = .032), HbA1c (p = .001), HOMA-IR (p = .037), TNF-α (p = .036), and hs-CRP (p = .027) significantly. At the end of the study, despite the significant decrease in serum levels of triglyceride (p = .027) and the increase in high-density lipoprotein cholesterol levels (p < .001) in the L-citrulline group, no significant differences were found for these parameters between the groups. Moreover, no significant inter- and intra-group changes were observed for dietary intakes, anthropometric indices, total and low-density lipoprotein cholesterol levels (p > .05). In conclusion, L-citrulline supplementation might improve glucose homeostasis, some lipid factors and inflammatory markers in overweight and obese patients with T2D.

The effects of taurine supplementation on glycemic control and serum lipid profile in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial.

Previous studies have suggested that taurine has hypoglycemic and hypolipidemic effects on experimental diabetic models. Therefore, this clinical trial was designed to explore the impacts of taurine supplementation on glycemic control and lipid profile in the patients with T2DM. This study was conducted on 45 patients with T2DM in Tabriz Sheikhor-raees Polyclinic and Imam-Reza Hospital Endocrine Center. Subjects were randomly divided into taurine and placebo groups. Accordingly, the taurine group (n = 23) received taurine 3000 mg/daily and the placebo group (n = 22) took crystalline microcellulose/daily for the duration of 8 weeks. At baseline and after the trial completion, fasting blood samples were obtained from the patients to assess the glycemic indicators and lipid profile. Independent t test, paired t test, Pearson's correlation, and analysis of covariance was used for analysis. At the end of the study, levels of FBS (p = 0.01), insulin (p = 0.01), HOMA-IR (p = 0.003), TC (p = 0.013), and LDL-C (p = 0.041) significantly decreased in the taurine group compared to the placebo group. In addition, there was no significant changes in HbA1c, triglyceride, HDL-C, anthropometric indicators or dietary intakes by passing 8 weeks from the intervention. In conclusion, the findings of the current study indicated that taurine supplementation (3000 mg/day) for 8 weeks could improve the glycemic indexes and lipid profiles including TC and LDL-C in the patients with T2DM.

The effects of taurine supplementation on oxidative stress indices and inflammation biomarkers in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Reduced serum level of taurine in type 2 diabetes mellitus (T2DM) was shown to be associated with the metabolic alterations and clinical complications of diabetes. Dietary supplementation with taurine may attenuate oxidative stress and inflammatory responses in T2DM as well as alleviate diabetes-induced complications. Hence, this study evaluated the effect of taurine supplementation on oxidative stress and inflammatory biomarkers in patients with T2DM. METHODS: Fifty patients with T2DM were randomly allocated to two groups to consume either taurine (containing 1000 mg taurine), or placebo (containing crystalline microcellulose) three times per day for 8 weeks. Anthropometric data, dietary intake, serum total antioxidant capacity (TAC), malondialdehyde (MDA), the activities of antioxidant enzymes superoxide dismutase (SOD) and catalase (CAT), serum levels of tumor necrosis factor alpha (TNF-α), interleukin 6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) were assessed before and after intervention. RESULTS: There was a significant increase in SOD (5.1%, p = 0.004) and CAT (4.22%, p = 0.001) after 8 weeks of taurine supplementation. In addition, serum levels of MDA (26.33%, p = 0.001), hs-CRP (16.01%, p = 0.001), and TNF-α (11.65%, p = 0.03) significantly decreased in the taurine group compared with baseline. Following treatment, the taurine group had fewer serum levels of MDA (p = 0.04), hs-CRP (p = 0.002) and TNF-α (p = 0.006) than the placebo group. Also, a significant increase was observed in SOD (p = 0.007), and CAT (p = 0.001) in the taurine group compared with the placebo group. There were no differences in the serum levels of IL-6 or TAC. CONCLUSIONS: The findings of this study showed that taurine supplementation improved some oxidative stress indices and inflammatory biomarkers in patients with T2DM.Trial registration The protocol of this clinical trial is registered with the Iranian Registry of Clinical Trials (http://www.IRCT.IR, identifier: IRCT20121028011288N16).

Potential roles of Citrulline and watermelon extract on metabolic and inflammatory variables in diabetes mellitus, current evidence and future directions: A systematic review.

OBJECTIVE: Diabetes mellitus is a prevalent endocrine disorder worldwide. Citrulline is an α-amino acid, which is abundant in watermelon, and a precursor of arginine and nitric oxide. Decreased bioavailability of nitric oxide is associated with insulin resistance. The present systematic review focused on the existing evidence of citrulline and watermelon extract effects on metabolic and inflammatory parameters in diabetes mellitus. METHODS: A systematic search of the databases PubMed, Scopus, EMBASE, ProQuest and Google Scholar was conducted for relevant papers published from inception until October 2018. All clinical trials, animal and in vitro studies published in the English language that assessed the role of citrulline and watermelon extract on diabetes mellitus, were eligible. Studies providing inadequate information were excluded. RESULTS: Out of 1262 articles we found, only eight articles met the inclusion criteria for analysis. In three studies an increase in the synthesis of nitric oxide was reported with citrulline and watermelon extract supplementation. Four studies showed a significant reduction in blood glucose after supplementation with watermelon extract, and two studies reported a decrease in a number of inflammatory biomarkers following citrulline supplementation. Although citrulline intake caused a significant reduction in HOMA-IR in one study, inconsistent results were revealed on the effects of citrulline and watermelon extract on insulin levels and lipid profile. CONCLUSION: Citrulline and watermelon extract could improve nitric oxide synthesis, glycaemic status and inflammation in diabetes mellitus. However, further studies are required to shed light on the underlying mechanisms.

Alpha lipoic acid supplementation improved antioxidant enzyme activities in hemodialysis patients.

Background: Cardiovascular disease (CVD) is the main cause of death in hemodialysis (HD) patients and oxidative stress is an important risk factor for CVD. Superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx) are primary antioxidant enzymes in human cells acting against toxic reactive oxygen species (ROS) and their reduced activity may contribute to oxidative disorders in HD patients. Alpha lipoic acid (ALA) as a potent strong antioxidant may affect these enzymes. Objective: We examined the effects of ALA supplementation on antioxidant enzyme activities in HD patients. Method: In this double-blinded, randomized clinical trial, 63 HD patients (43 males and 20 females; age range: 22-79 years) were assigned into the ALA group (n: 31), receiving a daily dose of ALA (600 mg), or a control group (n: 32), receiving placebo for 8 weeks. Body mass index (BMI), antioxidant enzymes, albumin (Alb) and hemoglobin (Hb) were determined before and after intervention. Results: At baseline, the mean blood activities of SOD, GPx, and CAT in ALA group were 1032±366, 18.9±5.09 and 191±82.7 U/gHb which increased at the end of study to 1149±502, 19.1±7.19 and 208±86.6 U/gHb respectively. However, only the increase of SOD was statistically significant in comparison with placebo group (P = 0.04). The mean levels of Alb, Hb, weight and BMI were not significantly changed in study groups (P>0.05). Conclusion: ALA may be beneficial for HD patients by increasing the activity of antioxidant enzymes; however, further studies are needed to achieve precise results.

Does Maternal Synbiotic Supplementation Affect Conjugated Linoleic Acid Level in Breast Milk? A Randomized Placebo-Controlled Clinical Trial.

AIM: As conjugated linoleic acid (CLA)is a potential growth promotor in newborns, the present pilot study aimed at measuring the effect of synbiotic supplementation on breast milk CLA level. MATERIALS AND METHODS: Sixty lactating mothers were randomly allocated to take either synbiotic (n = 31) or placebo (n = 29) for 30 days. Maternal anthropometric indices were measured at the onset and end of the study by standard methods and body mass index was calculated. Information on food intake was collected by using a 24 hours 24-hour recall method for 2 days and food record questionnaire for 1 day. Breast milk lipids were extracted and CLA level was quantified by gas chromatography. RESULTS: No significant differences were observed in the baseline mean breast milk concentrations of Fatty acids (FAs) between the synbiotic and placebo groups (p > 0.05). The CLA content of breast milk increased significantly by 58% (from 0.19 ± 0.15 to 0.30 ± 0.22 mmol/L) in the supplemented group, whereas it decrease decreased slightly but not significantly by 14% (from 0.22 ± 0.14 to 0.19 ± 0.10 mmol/L) in the placebo group. After adjustment for covariates, the CLA content of breast milk was significantly higher in the supplemented group compared with placebo group after the intervention (p = 0.03). The ratio of total n - 6:3 increased significantly over time in both groups, but was not different among groups (p < 0.05). CONCLUSIONS: This pilot study showed that supplementation of lactating women with synbiotic, resulted in increased breast milk CLA composition. Further research using different species of probiotic bacteria and analysis of maternal and infant plasma FAs would be beneficial.

Effect of Butyrate and Inulin Supplementation on Glycemic Status, Lipid Profile and Glucagon-Like Peptide 1 Level in Patients with Type 2 Diabetes: A Randomized Double-Blind, Placebo-Controlled Trial.

Studies on humans with diabetes mellitus showed that the crosstalk between the intestinal microbiota and the host has a key role in controlling the disease. The aim of this study was to evaluate the effects of sodium butyrate and high performance inulin supplementation simultaneously or singly on glycemic status, lipid profile, and glucagon-like peptide 1 level in adults with type 2 diabetes mellitus. Sixty patients were recruited for the study. The participants were randomly allocated, using randomized block procedure, to one of the four treatment groups (A, B, C, or D). Group A received sodium butyrate capsules, group B received inulin supplement powder, group C was exposed to the concomitant use of inulin and sodium butyrate, and group D consumed placebo for 45 consecutive days. Markers of glycemia, lipid profile, and glucagon-like peptide 1 were measured pre- and post-intervention. Dietary supplementation in groups A, B, and C significantly reduced diastolic blood pressure in comparison with the placebo group (p<0.05). Also, intra-group statistical analysis showed that only treatment with sodium butyrate + inulin (group C) significantly reduced fasting blood sugar (p=0.049) and waist to hip ratio (p=0.020). Waist circumference in groups B and C reduced significantly after the intervention (p=0.007 and p=0.011; respectively). The post hoc Tukey tests showed significant increase in glucagon-like peptide 1 concentration in groups A and C in comparison with group D (p<0.05). The results suggest that inulin supplementation may be useful to diabetic patients and these effects could be increased with butyrate supplement.

Effect of conjugated linoleic acid supplementation on quality of life in rectal cancer patients undergoing preoperative Chemoradiotherapy.

OBJECTIVES: This study set out with the aim of evaluating the effect of conjugated linoleic acid (CLA) supplementation on quality of life in rectal cancer patients undergoing to preoperative chemoradiotherapy. METHODS: In this study, 33 volunteer patients with rectal cancer treated with preoperative chemoradiotherapy were allocated in the CLA (n=16) and the placebo groups (n=17). The CLA group and placebo groups received 3 gr CLA/d and 4 placebo capsules for 6 weeks respectively. Before and after intervention, quality of life of patients was assessed by EORTC QLQ-C30. RESULTS: At the end of study, the mean scores of physical function, role function, and cognitive function enhanced significantly in the CLA group while reduced remarkably in the placebo group. Symptom scales improved in the CLA group at the end of study. Comparison of changes in fatigue, pain and diarrhea scores were statistically significant between two study groups (P<0.05). When we compared the global health status scores between two groups, significant changes were observed (P<0.001). CONCLUSION: It appears that CLA may be helpful in rectal cancer patients by improving global quality of life. Although, other clinical trials with large sample size are needed to achieve more precise results.

Perceived Barriers to Following Dietary Recommendations in Hypertensive Patients.

OBJECTIVE: Hypertension (HTN) is one of the most important public health problems in the world. Lifestyle modification including dietary changes such as following the Dietary to Stop Hypertension (DASH) plan is the first step to control HTN. The aim of the present study was to identify perceived barriers to following dietary recommendations in hypertensive patients in Zanjan, Iran. MATERIALS AND METHODS: In this cross-sectional study, 200 outpatients (161 women, 39 men) with essential HTN (systolic blood pressure [SBP] ≥ 140 mmHg and diastolic blood pressure [DBP] ≥ 90 mmHg) were recruited from August to November 2012. A 29-item structured questionnaire was designed to assess perceived barriers to follow dietary recommendations. Validity and reliability were assessed by content validity index, content validity ratio, and Chronbach's alpha, respectively. An exploratory factor analysis with a principal component analysis extraction method and varimax rotation was performed to extract the underlying factors. RESULTS: Mean age and body mass index (BMI) of participants were 46.9 ± 5.5 years and 30.6 ± 3.6 kg/m2, respectively. The exploratory factor analysis extracted 6 interpretable factors with eigenvalue > 1. In order of importance, they were social and environmental barriers (eigenvalue = 2.489), social gathering (eigenvalue = 2.379), compliance with recommended diet and preference of other family members (eigenvalue = 2.127), palatability of the recommended diet (eigenvalue = 1.972), emotional statues and psychological factors (eigenvalue = 1.921), and cost (eigenvalue = 1.845). Mentioned factors explained 44% of the total variance. CONCLUSION: Patients with HTN in our study perceived some barriers to following the recommended diet. In nutritional counseling, considering these barriers may be effective in improving the dietary adherence level in hypertensive patients.

Nigella sativa oil with a calorie-restricted diet can improve biomarkers of systemic inflammation in obese women: A randomized double-blind, placebo-controlled clinical trial.

BACKGROUND: Inflammation is one of the primary mechanisms in the development of metabolic complications. Although anti-inflammatory characteristics of Nigella sativa (NS) have been indicated in animal models, clinical trials related to the effects of NS on inflammatory parameters are relatively scarce. OBJECTIVE: The aim of the present study was to determine the effects of NS oil combined with a calorie-restricted diet on systemic inflammatory biomarkers in obese women. METHODS: In this double-blind placebo-controlled randomized clinical trial, 90 volunteer obese (body mass index = 30-34.9 kg/m(2)) women aged 25-50 years were recruited. Participants were randomly divided into two groups, an intervention group (n = 45) and a placebo group (n = 45). Each group received either: (1) a low-calorie diet with 3 g/day of NS oil or (2) a low-calorie diet with 3 g/day placebo for 8 weeks. RESULTS: A total of 84 females (intervention group = 43; placebo group = 41) completed the trial. Subjects in the intervention group did not report any side effects with the NS oil supplementation. NS oil decreased serum levels of tumor necrosis factor-alpha (-40.8% vs -16.1%, P = .04) and high-sensitivity C-reactive protein (-54.5% vs -21.4%, P = .01) compared to the placebo group. However, there were no significant changes in interleukin-6 levels (-8.6 vs -2.4%, P = .6) in the NS group compared to the placebo group. CONCLUSIONS: NS oil supplementation combined with a calorie-restricted diet may modulate systemic inflammatory biomarkers in obese women. However, more studies are needed to clarify the efficacy of NS oil as an adjunct therapy to improve inflammatory parameters in obese subjects.

Conjugated linoleic acid improves glycemic response, lipid profile, and oxidative stress in obese patients with non-alcoholic fatty liver disease: a randomized controlled clinical trial.

AIM: To investigate if conjugated linoleic acid supplementation (CLA) affects metabolic factors and oxidative stress in non-alcoholic fatty liver disease (NAFLD). METHODS: The study was a randomized, controlled clinical trial conducted in specialized and subspecialized clinics of Tabriz University of Medical Sciences from January 2014 to March 2015. 38 obese NAFLD patients were randomly allocated into either the intervention group, receiving three 1000 mg softgel of CLA with a weight loss diet and 400 IU vitamin E, or into the control group, receiving only weight loss diet and 400 IU vitamin E for eight weeks. Dietary data and physical activity, as well as anthropometric, body composition, metabolic factors, and oxidative stress were assessed at baseline and at the end of the study. RESULTS: Weight, body composition, and serum oxidative stress, insulin, and lipid profile significantly improved in both groups, while hemoglobin A1c (HbA1c) levels (P=0.004), total cholesterol to high density lipoprotein ratio (P=0.008), low density lipoprotein to high density lipoprotein ratio (LDL/HDL) (P=0.002), and alanine aminotransferase to aspartate aminotransferase (ALT/AST) ratio (P=0.025) significantly decreased in the intervention group. At the end of the study, fat mass (P=0.001), muscle mass (P=0.023), total body water (P=0.004), HbA1c (P<0.001), triglycerides (P=0.006), LDL/HDL ratio (P=0.027), and ALT/AST ratio (P=0.046) were significantly better in the CLA group than in the control group. CONCLUSION: CLA improved insulin resistance, lipid disturbances, oxidative stress, and liver function in NAFLD. Therefore, it could be considered as an effective complementary treatment in NAFLD.

Perceived barriers to recommended dietary adherence in patients with type 2 diabetes in Iran.

OBJECTIVE: To identify barriers to recommended dietary adherence in patients with type 2 diabetes. DESIGN: Observational cross-sectional study. SAMPLE: One hundred-forty six overweight/obese volunteers with type 2 diabetes, who had previously received dietary advice for at least one year, were recruited from two diabetes clinics in Tabriz, north-west of Iran. MEASUREMENTS: A 24-item questionnaire was designed to assess dietary barriers. The validity and reliability of the questionnaire were assessed by Content Validity Index, Content Validity Ratio and Cronbach's alpha, respectively. An exploratory factor analysis with principal component analysis extraction and varimax rotation was utilized in order to extract the underlying factors of dietary nonadherence. RESULTS: Factor analysis yielded seven barrier factors including: situational barriers/difficulty resisting temptation [percent variance=11.64%], stress-related eating disorder/cost [percent variance=9.11%], difficulty with meal and snack plans [percent variance=8.76%], confusion [percent variance=8.45%], work-related issues [percent variance=7.72%], small portion size [percent variance=6.87%] and lack of palatability/family support [percent variance=6.78%]. These factors explained about 59.4% of the total variance. CONCLUSIONS: Overall, patients with type 2 diabetes perceived some barriers to recommended dietary adherence. In dietary counseling, considering and addressing these barriers will likely be effective in increasing the dietary adherence for patients with type 2 diabetes in Iran.

Effects of Elaeagnus angustifolia L. on Lipid Profile and Atherogenic Indices in Obese Females: A Randomized Controlled Clinical Trial.

In the present randomized double-blinded placebo-controlled study, the effect of Elaeagnus angustifolia L. (EA) whole fruit and medulla powders on anthropometric indices, serum lipid profile, and atherogenic indices in females with knee osteoarthritis (OA) was investigated. Ninety females with mild to moderate knee osteoarthritis were randomly assigned to one of three groups-medulla powder, whole fruit powder, or placebo. The subjects received 15 g/day of medulla powder of EA, whole fruit powder of EA, or placebo. Lipid profile, weight, and dietary intake were measured at baseline and at the end of the study. Body mass index and atherogenic indices were calculated. Statistical analysis was performed using SPSS version 13.0, and Paired t tests, analysis of variance (ANOVA), analysis of covariance (ANCOVA), and the Tukey post hoc test were used to compare within-group and between-group values. After 8 weeks of supplementations, compared with the baseline, significant reductions in total cholesterol (TC), low density lipoprotein/high density lipoprotein (LDL/HDL), and TC/HDL ratios were observed in the two supplemented groups; however, the reduction of these values was not statistically significant in the placebo group. There were significant differences between the patients who received medulla powder and placebo group in the case of changes in TC/HDL and LDL/HDL ratios (p < .001). However, no significant differences were found between the two supplemented groups in the case of changes in studied values (p > .05). Generally, whole fruit and medulla powders of Elaeagnus angustifolia L. had positive effects, especially in decreasing total cholesterol and atherogenic indices in females with knee OA.

Effects of l-Carnitine Supplementation on Serum Inflammatory Factors and Matrix Metalloproteinase Enzymes in Females with Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

OBJECTIVE: Considering the importance of inflammation in the pathogenesis of osteoarthritis (OA) and induction of pain, this study was aimed to investigate the effect of L-carnitine supplementation on serum inflammatory mediators and OA-associated pain in females with knee OA. METHODS: In this clinical trial, 72 females with mild to moderate knee osteoarthritis started the study, divided into 2 groups to receive 750 mg/day L-carnitine (n = 36) or placebo (n = 36) for 8 weeks. Serum levels of Interleukine-1ß (IL-1ß), high-sensitivity C-reactive protein (hs-CRP), matrix metalloproteinases (MMPs)-1 and -13, and visual analog scale (VAS) for pain were assessed before and after supplementation. Data were analyzed by t test, Wilcoxon signed rank test, Mann-Whitney U test, and analysis of covariance. RESULTS: Only 69 patients (33 in the L-carnitine group and 36 in the placebo group) completed the study. L-Carnitine supplementation decreased serum IL-1ß and MMP-1 levels significantly (p = 0.001 and p = 0.021, respectively); however, serum hs-CRP and MMP-13 levels did not change significantly (p > 0.05). In the placebo group, serum IL-1ß levels increased significantly (p = 0.011), whereas other studied biomarkers did not change significantly. The mean VAS score decreased significantly in the L-carnitine and placebo groups by 52.67% and 21.82%, respectively (p < 0.001). Significant differences were only observed between the 2 groups in serum IL-1ß (p < 0.001) and MMP-1 (p = 0.006) levels and mean VAS score (p = 0.002) after adjusting for baseline values and covariates. CONCLUSION: Despite observed beneficial effects of short-term supplementation of L-carnitine in decreasing serum inflammatory mediators and improving pain in knee OA patients, further studies are needed to achieve concise conclusions.

L-Carnitine supplementation improved clinical status without changing oxidative stress and lipid profile in women with knee osteoarthritis.

Considering the pathologic importance of oxidative stress and altered lipid metabolism in osteoarthritis (OA), this study aimed to investigate the effect of l-carnitine supplementation on oxidative stress, lipid profile, and clinical status in women with knee OA. We hypothesized that l-carnitine would improve clinical status by modulating serum oxidative stress and lipid profile. In this randomized double-blind, placebo-controlled trial, 72 overweight or obese women with mild to moderate knee OA were randomly allocated into 2 groups to receive 750 mg/d l-carnitine or placebo for 8 weeks. Dietary intake was evaluated using 24-hour recall for 3 days. Serum malondialdehyde (MDA), total antioxidant capacity (TAC) and lipid profile, visual analog scale for pain intensity, and patient global assessment of severity of disease were assessed before and after supplementation. Only 69 patients (33 in the l-carnitine group and 36 in the placebo group) completed the study. l-Carnitine supplementation resulted in significant reductions in serum MDA (2.46 ± 1.13 vs 2.16 ± 0.94 nmol/mL), total cholesterol (216.09 ± 34.54 vs 206.12 ± 39.74 mg/dL), and low-density lipoprotein cholesterol (129.45 ± 28.69 vs 122.05 ± 32.76 mg/dL) levels compared with baseline (P < .05), whereas these parameters increased in the placebo group. Serum triglyceride, high-density lipoprotein cholesterol, and TAC levels did not change significantly in both groups (P > .05). No significant differences were observed in dietary intake, serum lipid profile, MDA, and TAC levels between groups after adjusting for baseline values and covariates (P > .05). There were significant intragroup and intergroup differences in pain intensity and patient global assessment of disease status after supplementation (P < .05). Collectively, l-carnitine improved clinical status without changing oxidative stress and lipid profile significantly in women with knee OA.

Oxidative Stress Responses to Nigella sativa Oil Concurrent with a Low-Calorie Diet in Obese Women: A Randomized, Double-Blind Controlled Clinical Trial.

The aim of the present study was to determine the effects of Nigella sativa (NS) oil concurrent with a low-calorie diet on lipid peroxidation and oxidative status in obese women. In this double-blind placebo-controlled randomized clinical trial, 50 volunteer obese (body mass index = 30-35 kg/m(2)) women aged 25-50 years old were recruited. Participants were randomly divided into intervention (n = 25) and placebo (n = 25) groups. They received a low-calorie diet with 3 g/day NS oil or low-calorie diet with 3 g/day placebo for 8 weeks. Forty-nine women (intervention group = 25; placebo group = 24) completed the trial. NS oil concurrent with a low-calorie diet decreased weight in the NS group compared to the placebo group (-4.80 ± 1.50 vs. -1.40 ± 1.90 kg; p < 0.01). Comparison of red blood cell superoxidase dismutase (SOD) indicated significant changes in the NS group compared to the placebo group at the end of the study (88.98 ± 87.46 vs. -3.30 ± 109.80 U/gHb; p < 0.01). But no significant changes in lipid peroxidation, glutathione peroxidase, and total antioxidant capacity concentrations were observed. NS oil concurrent with a low-calorie diet decreased weight and increased SOD levels in obese women. However, more studies are suggested to confirm the positive effects of NS in obesity and its complications.

Effects of Nigella sativa oil with a low-calorie diet on cardiometabolic risk factors in obese women: a randomized controlled clinical trial.

Obesity is typically associated with increased risk factors of cardiovascular diseases (CVDs). Therefore, a therapeutic approach that aims to control body weight and metabolic profile might be effective in preventing CVDs. We aimed to determine the effects of Nigella Sativa (NS) oil with a low-calorie diet on cardiometabolic risk factors in obese women. In this double-blind randomized controlled clinical trial, 90 obese women were recruited. Participants were females aged 25-50 years old with body mass index (BMI) between 30 and 35 kg m(-2). They were randomly assigned to receive a low-calorie diet with 3 g per day (1 g before each meal) NS oil or placebo for 8 weeks. Anthropometric indices, dietary intake and biochemical parameters were measured at the baseline and after the intervention. Eighty-four females completed the trial (intervention n = 43, placebo n = 41). Two groups were similar in the baseline characteristics. After the intervention, dietary intake was changed in both groups compared to the baseline, but the differences were not significant between the two groups. In the NS group, weight (-6.0 vs. -3.6%; p < 0.01) and waist circumference (-6.9 vs. -3.4%; p < 0.01) decreased significantly compared with the placebo group at the end of the trial. Comparison of biochemical parameters presented a significant decline in triglyceride (-14.0 vs. 1.4%; p = 0.02) and very low density lipoprotein (-14.0 vs. 7%; p < 0.01) levels in the NS group compared to the placebo group. NS oil concurrent with a low-calorie diet can reduce cardiometabolic risk factors in obese women. However, more clinical trials are needed to elucidate efficacy of NS as a complementary therapy in obese subjects.