A case-control study of drinking beverages and the risk of multiple sclerosis in Iran.

BACKGROUND: There is no study in the world on the relationship between consuming black and green tea as beverages containing polyphenols and the risk of MS. This study aimed to determine the association between the consumption of green and black tea, coffee, non-alcoholic beer, milk, fruit juices and carbonated beverages with the risk of MS. METHODS AND MATERIALS: This case-control study was performed on 150 patients with MS and 300 healthy individuals as a control group among patients who were referred to the ophthalmology ward of a referral hospital in Ahvaz with the groups matching for age. The data collection tool was a researcher-made questionnaire including demographic information and beverage consumption. Analysis was performed using univariate and multiple logistic regression models. RESULTS: The mean age of patients at the time of diagnosis was 38.55 ± 8.88 years. The results showed that drinking milk (OR = 5.46), natural juice (OR = 2.49), and carbonated beverages (OR = 16.17) were associated with an increased chance of developing MS. However, drinking non-alcoholic beer (OR = 0.48), black tea (OR = 0.20), green tea (OR = 0.29) and coffee (OR = 0.07) were associated with a reduced chance of developing MS. CONCLUSION: The results show that drinking black and green tea, non-alcoholic beer, and coffee are associated with a decrease in the chance of developing MS. The results of this study can be used to design interventional research and to change people's lifestyles to prevent MS.

The effect of berberine and fenugreek seed co-supplementation on inflammatory factor, lipid and glycemic profile in patients with type 2 diabetes mellitus: a double-blind controlled randomized clinical trial.

BACKGROUND: Type 2 Diabetes mellitus is one of the most common chronic diseases in the world and has many complications. Due to the importance of using alternative therapies in managing symptoms of this disease, the present study was designed and conducted to investigate the effect of co-supplementation of berberine and fenugreek in patients with type 2 diabetes mellitus. METHODS: A randomized controlled clinical trial was conducted on 50 patients with type 2 diabetes mellitus. Participants were randomized in the intervention group, which received 3 capsules/day of 500 mg (300 mg of berberine + 200 mg of fenugreek seed powder) or placebo for 12 weeks. Biochemical and anthropometric variables were measured at the beginning and end of the study. RESULTS: We observed that fasting insulin, HbA1C, and hs-CRP significantly decreased in the intervention group compared to the baseline. The mean difference in insulin resistance (-0.32 vs. 0.15), fasting blood sugar (-14.40 vs. 1.68), and fasting insulin (- 2.18 vs. 1.34) were clinically significant in comparison to the control group. Almost all domains of SF-12 scores were significantly higher in the intervention group than in the placebo group. CONCLUSIONS: The combination of berberine and fenugreek seed can improve cardio-metabolic status in patients with diabetes and support the anti-diabetic and anti-inflammatory role of herb in the improvement of quality of life.

The synergic effects of alpha-lipoic acid supplementation and electrical isotonic contraction on anthropometric measurements and the serum levels of VEGF, NO, sirtuin-1, and PGC1-α in obese people undergoing a weight loss diet.

Background: The anti-obesity effects of Alpha-lipoic acid (α-LA) and isotonic contraction has been reported. However, the underlying mechanism is not fully understood. This study aimed to investigate the effect of 1200 mg/day α-LA supplementation and 3 sessions per week of Faradic (an electrical stimulating system) on anthropometric parameters, body composition, VEGF, Sirtuin-1, nitric oxide (NO), and PGC1-α in obese people undergoing a weight loss regime.Methods: This randomised clinical trial was carried out on 100 obese adults. The subjects were randomly assigned to four groups of 25 subjects including Faradic, α-LA, α-LA + Faradic, and control. A Bio Impedance Analyser (BIA) was used to estimate anthropometric measurements including weight, body mass index (BMI), fat mass, and fat free mass. The serum levels of Sirtuin-1, PGC1-α, VEGF, and NO levels were measured. All measurements were done at baseline and after 8 weeks of the intervention.Results: A significant weight reduction was observed in all four groups compared to baseline (p<.01). The placebo group had significantly higher weight, BMI, weight circumstance (WC), and body fat (BF) compared with the other groups. The α-LA + Faradic group had significantly lower weight, BMI, BF, WC than control, faradic, and α-LA groups and higher, Sirtuin and PGC than the control group (all p < .05).Conclusions: The findings indicated that the α-LA and Faradic interventions may have a synergistic effect on weight, BMI, BF, WC, and SLM, possibly through changes in serum level of VEGF, NO, and PGC. Further studies are warranted to clarify the mutual effects of -α-LA and Faradic on obesity and its molecular mechanisms. Name of the registry: Iranian Registry of Clinical TrialsTrial registration number: IRCT20131117015424N2Date of registration: 04/04/2018URL of trial registry record: https://www.irct.ir/search/result?query=IRCT20131117015424N2.

The effect of alpha-lipoic acid supplementation and electrical isotonic contraction on anthropometric parameters, body composition and angiogenesis factor, sirtunin-1 and peroxisome proliferator-activated receptor-γ coactivator-1α in obese people under a weight loss regime: A study protocol for a randomized controlled clinical trial.

BACKGROUND: Obesity is defined as a chronic disease, and is known as a public health problem in developed and developing countries. Several studies have shown the effects of anti-obesity of α-lactalbumin. AIM: This study was designed to investigate the effect of alpha-lipoic acid supplementation and electrical isotonic contraction on anthropometric parameters, body composition and angiogenesis factor, sirtunin-1 and peroxisome proliferator-activated receptor-γ coactivator-1α (PGC1α) in obese people under a weight loss regime. METHODS: Obese people who meet the inclusion criteria are included. Participants are randomly divided into four groups (alpha-lipoic (1200 mg) +weight loss regime group; Faradic (three 1 hour sessions) + weight loss regime group; alpha-lipoic (1200 mg) + Faradic (three 1 hour sessions) + weight loss regime group; control group (1200 mg placebo) for 2 months. At the beginning and the end of the study, demographic information, dietary intake, anthropometric parameters, body composition and serum levels of the angiogenesis factor (sirtunin-1, PGC1α and nitric oxide) are measured. CONCLUSION: Recent studies reported the anti-obesity effects of alpha-lipoic acid. This study is novel, since a similar study has not yet been carried out. This study evaluates the effect of 600 mg of alpha-lipoic acid supplementation or having three sessions of 1 hour per week electrical isotonic contraction induced by Faradic for 2 months alone or in combination in obese people that are undergoing a weight loss regime. TRIAL REGISTRATION: Iran Clinical Trials Registry, ID: IRCT20131117015424N2. Registered 2018-04-02.

Effect of weight-loss diet combined with taurine supplementation on body composition and some biochemical markers in obese women: a randomized clinical trial.

Taurine (Tau), an endogenous non-protein and sulfuric-amino acid, is involved in various biological pathways including anti-inflammatory, anti-oxidation, insulin resistance inhibition, and lipid profile improvement. According to some experimental and clinical studies, insulin resistance and excess body weight are associated with reduced serum level of Tau. Therefore, this study was aimed to evaluate Tau supplementation and a diet-induced weight-loss intervention on body composition and some biochemical indices of obese women. Participants were divided randomly into the intervention (standard weight-loss group + cap Tau 3 g/day for 8 weeks, n = 20) and control (standard weight-loss group + cap placebo for 8 weeks, n = 18) groups. To achieve weight loss, all participants received an individualized diet that included a 30% reduction in their total energy intake. Chi-square test was applied to compare categorical variables between two groups at baseline. Paired t test and independent-sample t test were also used to analyze the parametric continuous data within and between the two groups, respectively. Analysis of covariance was run for controlling the confounding variables. At the post-intervention, the mean changes of total cholesterol (p = 0.03), low-density lipoprotein cholesterol (p = 0.03), leptin (p = 0. 006), total adiponectin (p = 0.04), and high sensitivity C-reactive protein (p = 0.03) decreased significantly in Tau group compared with the control group. No significant results were found in the mean changes of high-density lipoprotein cholesterol, anthropometric measurements, glycemic indices, and liver enzymes between the two groups (p > 0.05). The findings showed that Tau supplementation along with a weight-loss diet may be more effective in improving the lipid profile and metabolic risk factors compared with a weight-loss diet alone.

Whey protein supplementation reducing fasting levels of anandamide and 2-AG without weight loss in pre-menopausal women with obesity on a weight-loss diet.

BACKGROUND: Despite the importance of dairy proteins in modifying of metabolic abnormalities, no attention has been given to their effects on endocannabinoids. METHODS: A total number of 60 obese women were recruited in a 2-month randomized clinical trial. Following random allocation, they were assigned to one of the two groups: control (n = 30) and intervention (n = 30). Then, all the subjects followed a hypocaloric diet of 800 kcal below estimated energy needs. The intervention group received isocaloric weight-loss diet and whey protein powders (30 g/day). Baseline and 2-month fasting anthropometric, blood glucose, serum insulin, insulin resistance, lipid profile, AEA, and 2-AG were measured. RESULTS: The study groups were homogenous in terms of baseline characteristics (p > 0.05) except for MUFA intake (p = 0.021). There were no significant differences in energy and macronutrient intakes in the intervention group compared to the control group at the end of the study (p > 0.05). The results of the ANCOVA did not show significant reductions in body weight and BMI of the intervention group compared to the control group (p > 0.05); however, WC, body fat, FBS, AEA, 2-AG, total cholesterol, and triglyceride decreased and HDL-c significantly increased in the intervention group compared to the control group (p < 0.05). CONCLUSIONS: In this study, the effects of simultaneous weight-loss diet and whey protein supplementation on the reduction of endocannabinoids were determined. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT2017021410181N8 . Registered on March 2017.

The effects of Anethum graveolens (dill) powder supplementation on clinical and metabolic status in patients with type 2 diabetes.

BACKGROUND: The objective of this study was to investigate the effects of Anethum graveolens (dill) powder supplementation on glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal symptoms in patients with type 2 diabetes. MATERIALS AND METHODS: In this study, 42 patients with type 2 diabetes were randomly allocated to intervention and control groups and received either 3 g/day dill powder or placebo (3 capsules/day, 1 g each). Fasting blood sugar, insulin, homeostatic model assessment of insulin resistance, lipid profile, high-sensitivity C-reactive protein, total antioxidant capacity, malondialdehyde and gastrointestinal symptoms were measured in all of the subjects at baseline and postintervention. RESULTS: The dill powder supplementation significantly decreased the mean serum levels of insulin, homeostatic model assessment of insulin resistance, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde in the intervention group in comparison with the baseline measurements (P < 0.05). Furthermore, the mean serum levels of high-density lipoprotein and total antioxidant capacity were significantly increased in the intervention group in comparison with the baseline measurement (P < 0.05). Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01). The mean changes in insulin, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde were significantly lower in the intervention group than in the control group (P < 0.05). In addition, the mean changes in high-density lipoprotein were significantly higher in the intervention group than in the control group (P < 0.05). CONCLUSION: Dill powder supplementation can be effective in controlling the glycemic, lipid, stress oxidative and gastrointestinal symptoms in patients with type 2 diabetes. TRIAL REGISTRATION: Iran Clinical Trials Registry: IRCT20120704010181N12. Registered on 12 May 2018.

Effects of Vitamin D and Omega-3 Fatty Acids Co-Supplementation on Inflammatory Factors and Tumor Marker CEA in Colorectal Cancer Patients Undergoing Chemotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Objectives: This study aimed to investigate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory factors and tumor marker CEA in colorectal cancer patients undergoing chemotherapy.Methods: In this study, 81 patients with stage ӀӀ or ӀӀӀ colorectal cancer were randomly assigned into four groups: (1) control: receiving a vitamin D placebo, weekly + two omega-3 fatty acid placebo capsules, daily; (2) omega-3 fatty acid, receiving two omega-3 fatty acid capsules (each capsule containing 330 mg of omega-3 fatty acids), daily + a vitamin D placebo, weekly; (3) vitamin D, receiving a 50,000 IU vitamin D soft gel, weekly + two omega-3 fatty acid placebo capsules, daily; (4) co-supplementation, receiving a 50,000 IU vitamin D soft gel, weekly + two omega-3 fatty acids capsules, for 8 weeks. Before and after the intervention, serum levels of 25(OH)D, TNF-α, IL-1ß, IL-6, IL-8, NF-kB activity, and tumor marker CEA, were measured.Results: After 8 weeks of intervention, patients who received combined vitamin D and omega-3 fatty acids supplements compared with omega-3, vitamin D, and placebo had significantly decreased TNF-α, and IL-1ß (P < .05). In addition, serum levels of TNF-α, IL-1ß, IL-6, IL-8, and tumor marker CEA were decreased significantly in omega-3, vitamin D, and co-supplementation of them, compared with baseline. NF-kB activity was decreased significantly in vitamin D and co-supplementation groups, compared with baseline. Regarding CEA, there was no significant difference between the four groups at the end of intervention (P > .05).Conclusion: Results show that co-supplementation of vitamin D and omega-3 fatty acids co-supplementation, in colorectal cancer patients have beneficial impacts on inflammation and tumor marker CEA.

Ginger in patients with active ulcerative colitis: a study protocol for a randomized controlled trial.

BACKGROUND: As a lifetime disorder, ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that affects quality of life and also demands long-term interventions. In spite of considerable side effects and sometimes restricted uses, efficient medications are available for UC treatment. Some in vitro and in vivo examinations have correspondingly introduced ginger and its active components with antioxidant, anti-inflammatory, and anti-ulcerative properties. Therefore, this trial aims to evaluate the effect of ginger supplementation on patients with active UC. METHODS: This study will be a 12-week, double-blind, parallel-group, randomized, controlled trial (RCT) in which 44 patients will be allocated to ginger and placebo groups receiving basic routine treatments plus ginger or placebo capsules, respectively. The primary outcomes are inflammatory markers (TNF-α and hs-CRP) and total antioxidant capacity. DISCUSSION: The findings of this trial will provide evidence on the effect of ginger on patients with active UC. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20190129042552N1. Registered on 21 June 2019.

Randomized Study Design to Test Effects of Vitamin D and Omega-3 Fatty Acid Supplementation as Adjuvant Therapy in Colorectal Cancer Patients.

This study examines the effects of vitamin D and omega-3 fatty acid co-supplementation on inflammation and nutritional status in colorectal cancer patients. Patients were randomly assigned into four groups: (1) controls, receiving placebos; (2) omega-3 fatty acid arm, receiving two 330 mg omega-3 fatty acid capsules daily and placebo (for vitamin D3) weekly; (3) vitamin D arm, receiving a 50,000 IU vitamin D3 soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation arm, receiving a 50,000 IU vitamin D3 soft gel weekly and two 330 mg omega-3 fatty acids capsules daily for 8 weeks. As outcomes, we measure height; weight; fat-free mass (FFM); serum levels of 25(OH)D, TNF-α, and IL-6; C-CRP; and albumin, before and after the intervention. The presented results show that vitamin D3 plus omega-3 fatty acid co-supplementation in colorectal cancer patients has beneficial impacts on inflammation and nutritional status.

Effects of vitamin D3 supplementation for 12 weeks on serum levels of anabolic hormones, anaerobic power, and aerobic performance in active male subjects: A randomized, double-blind, placebo-controlled trial.

Maintenance of the serum 25-hydroxyvitamin D (25-OH-D) concentration at recommended levels is essential due to its role in the regulation of anabolic hormones and athletic performance. However, the results of the clinical experiments in athletes are controversial. The present study aimed to investigate the effect of vitamin D3 supplement on serum levels of anabolic hormones, cortisol, anaerobic and aerobic performance in active males. In this double-blind, randomized controlled trial, 46 active males randomly assigned to vitamin D3 supplement (VDS; 2000 IU/day) or placebo for 12 weeks. The Wingate test, VO2max, and serum levels of 25-OH-D, Parathyroid hormone (PTH), total testosterone, growth hormone (GH), Insulin-like growth factor-1 (IGF-1), and cortisol were assessed. Subjects in the VDS group had a higher serum level of 25-OH-D (p = 0.004), VO2max (p = 0.016), and average power (p = 0.044) compared to the placebo at the end of the study. Also, lower levels of PTH (p = 0.004) and fatigue index (p < 0.001) were observed in VDS group at the end of the study. The serum cortisol levels were reduced significantly only in subjects with vitamin D deficiency in VDS group (p = 0.042). There was a significant reduction in serum testosterone levels in VDS group (p = 0.013). No change was indicated in serum levels of GH and IGF-1 in VDS group compared to the placebo (p > 0.05). The present study showed an improvement in aerobic capacity, anaerobic performance, and vitamin D status following vitamin D3 supplementation. However, more studies are required for the effect of vitamin D3 on serum concentration of anabolic hormones.

An energy-restricted high-protein diet supplemented with ß-cryptoxanthin alleviated oxidative stress and inflammation in nonalcoholic fatty liver disease: a randomized controlled trial.

The efficacy of ß-cryptoxanthin (BCX), a high-protein diet (HPD), or both in reducing oxidative stress and inflammation in nonalcoholic fatty liver disease (NAFLD) has never been examined within a randomized controlled trial (RCT). Thus, we aimed to assess the efficacy of an energy-restricted HPD supplemented with BCX in alleviating these conditions in NAFLD in an RCT design. We hypothesized that this combination may improve oxidative stress and inflammation in NAFLD as compared to a standard energy-restricted diet. Ninety-two ultrasonographically confirmed overweight/obese adult NAFLD patients attending an outpatient clinic in Ahvaz, Iran, were recruited for this 12-week, single-center, parallel-group, double-blind RCT from 2017 to 2018. Subjects were randomized into 4 equal groups (n = 23): HPD-BCX (energy-restricted HPD + BCX), HPD (energy-restricted HPD + placebo), BCX (standard energy-restricted diet + BCX), and control (standard energy-restricted diet + placebo). Serum levels of oxidative stress- and inflammation-related markers, as primary outcome measures, were determined at baseline and at the study end point. The 1-way analysis of covariance models in the intention-to-treat population (N = 92) showed that the HPD-BCX group achieved greater 12-week reductions in malondialdehyde, high-sensitivity C-reactive protein, interleukin-6, and total cytokeratin-18 (CK18-M65) but higher increases in total antioxidant capacity and adiponectin compared to the control group (mean differences for malondialdehyde, high-sensitivity C-reactive protein, interleukin-6, total cytokeratin-18, total antioxidant capacity, and adiponectin were -1.9 nmol/mL, -1.0 mg/L, -2.0 ng/L, -270.9 ng/L, 2.5 U/mL, and 1.9 mg/L, respectively; all P < .001). These results show that an energy-restricted HPD supplemented with BCX more efficaciously alleviates oxidative stress and inflammation in NAFLD as compared to a standard energy-restricted diet.

Randomized Study of the Effect of Vitamin D and Omega-3 Fatty Acids Cosupplementation as Adjuvant Chemotherapy on Inflammation and Nutritional Status in Colorectal Cancer Patients.

This study aimed to evaluate the effects of vitamin D3 and omega-3 fatty acids cosupplementation on inflammation and nutritional status in colorectal cancer patients. In this clinical trial, 81 colorectal cancer patients were randomly assigned into four groups: (1) control group: receiving a vitamin D3 placebo weekly + omega-3 fatty acid placebo capsules daily; (2) omega-3 fatty acid group: receiving 2 omega-3 fatty acid capsules (each capsule containing 330 mg of omega-3 fatty acids) daily + a vitamin D3 placebo weekly; (3) vitamin D group: receiving a 50,000 IU vitamin D3 soft gel weekly + 2 omega-3 fatty acid placebo capsules daily; (4) cosupplementation group: receiving a 50,000 IU vitamin D3 soft gel weekly + 2 omega-3 fatty acids capsules daily for 8 weeks. Before and after the intervention, height, weight, fat-free mass (FFM), serum levels of 25(OH)D, tumor necrosis factor alpha (TNF-α), and interleukin 6 (IL-6), C-reactive protein (CRP), and albumin, were measured. After 8 weeks of intervention, patients who received combined vitamin D3 and omega-3 fatty acids supplements compared with omega-3, vitamin D3, and placebo groups had significantly decreased CRP and TNF-α. In addition, serum level of IL-6 was decreased significantly in omega-3, vitamin D3, and cosupplementation groups compared with baseline. Regarding nutritional status, weight, BMI, and FFM% were increased significantly in vitamin D3, omega-3, and cosupplementation groups at the end of the intervention. Vitamin D3 plus omega-3 fatty acids cosupplementation in colorectal cancer patients has beneficial impacts on inflammation and nutritional status.

Effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in patients with colorectal cancer: a study protocol for a double blind randomized controlled trial.

BACKGROUND: Much evidence is available demonstrating that both vitamin D and omega-3 fatty acids block the development and progression of colonic carcinogenesis. The results of animal studies have shown that the consumption of omega-3 fatty acids can decrease inflammatory biomarkers, enhance the efficacy of chemotherapy, and decrease the side effects of chemotherapy or cancer. Also, observational studies propose that higher levels of 25(OH)D are related to improved survival of colorectal cancer patients. This study will aim to evaluate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in colorectal cancer patients. METHODS/DESIGN: We will carry out an 8-week double-blind randomized, placebo-controlled clinical trial to evaluate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in patients with stage ӀӀ or ӀӀӀ colorectal cancer undergoing chemotherapy. DISCUSSION: Because of the important effects of vitamin D and omega-3 fatty acids on molecular pathways involved in cancer development and progression, it seems that both vitamin D and omega-3 fatty acids may provide a new adjuvant therapy by decreasing inflammatory biomarkers and resistance to cancer treatment in patients with colorectal cancer. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20180306038979N1. Registered on 16 March 2018.

Evaluation of the effect of oral taurine supplementation on fasting levels of fibroblast growth factors, ß-Klotho co-receptor, some biochemical indices and body composition in obese women on a weight-loss diet: a study protocol for a double-blind, randomized controlled trial.

BACKGROUND: Taurine (Tau) is involved in many biochemical functions such as regulation of glucose and lipid metabolism, enhancement of energy expenditure, anti-inflammatory effects and appetite control. The most important effect of Tau in obesity is its direct effect on adipose tissue. Some evidence has shown an impaired FGF (fibroblast growth factor) 19 and 21 biosyntheses in obesity. Besides the effects of eicosapentaenoic acid on serum FGF concentrations, the effect of other nutrients on FGFs is not clear. Since obesity as an important health problem is rising around the world and on the other side, Tau biosynthesis is reduced by adipose-tissue-derived factors in obesity, the effects of Tau and a weight-loss diet on obesity need to be investigated further. METHODS: We will conduct an 8-week. double-blind, parallel-group, randomized controlled clinical trial to investigate the effect of Tau supplementation on fasting serum levels of FGFs, ß-Klotho co-receptor, some biochemical indices and body composition in 50 obese women aged between 18 and 49 years on a weight-loss diet. DISCUSSION: We will determine the other advantages of a weight-loss diet on new metabolic risk factors. Since Tau may regulate adipose-tissue-derived factors and a weight-loss diet can promote the useful effects of Tau supplementation; for the first time, the effects of a weight-loss diet along with Tau supplementation on these variables will be assessed. TRIAL REGISTRATION: Iran Clinical Trials Registry, ID: IRCT20131125015542N2 . Registered on 24 November 2018.

Effect of a high-protein diet with ß-cryptoxanthin supplementation on metabolic risk factors, oxidative and inflammatory biomarkers in non-alcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled clinical trial.

BACKGROUND: Excessive hepatic fat is associated with increased metabolic risk factors, production of inflammatory factors, and oxidative stress. High protein intake might trigger an increased hepatic lipid oxidation through an increase in hepatic energy expenditure. Furthermore, the majority of randomized controlled trials (RCT) in humans have failed to show whether carotenoids can be used to prevent and treat non-alcoholic fatty liver disease (NAFLD). However, it is notable and contradictory that NAFLD is rapidly escalating in Iran and other countries with lower intakes of fruit and vegetables (as sources of ß-cryptoxanthin [ß-CX] and carbohydrates) and higher intake of carbohydrates (as an agent of NAFLD); and the effects of ß-CX and a high protein diet (HPD) on NAFLD need to be investigated further. METHODS/DESIGN: This study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for 12 weeks to receive daily ß-CX 6 mg supplementation combined with a HPD on levels of metabolic factors, ß-CX, glycemic and lipid profiles, inflammatory factors, adipocytokines, and body composition. Ninety-two eligible patients, aged 18-60 years, of both genders, who are obese and overweight (body mass index [BMI] 25-40 kg/m2) will be randomly assigned to four groups as follow: HPD + placebo; normal protein diet + ß-CX (NPD + ß-CX); HPD + ß-CX; and NPD + placebo (control group). Two populations will be analyzed in this work. The intention-to-treat (ITT) population includes all patients who will be randomized, while the per-protocol (PP) population includes all individuals who complete the 12- week intervention (i.e. study completers). DISCUSSION: Our findings from this trial will contribute to the knowledge of the relationship between ß-CX supplementation and a HPD on NAFLD patients and determination of optimal macronutrient ratios without energy restriction. TRIAL REGISTRATION: Iran clinical trials registry, IRCT2017060210181N10 . Registered on 20 June 2017.

Impact of Cranberry Juice Enriched with Omega-3 Fatty Acids Adjunct with Nonsurgical Periodontal Treatment on Metabolic Control and Periodontal Status in Type 2 Patients with Diabetes with Periodontal Disease.

OBJECTIVES: Cranberries, high in polyphenols, have been associated with a favorable glycemic response in patients with type 2 diabetes and also are beneficial for oral health. Because type 2 diabetes mellitus and periodontal disease have a physiological relationship, this study aimed to evaluate the hypothesis that cranberry juice enriched with omega-3 will improve glycemic and lipid profiles and periodontal status in patients with diabetes with periodontal disease. MATERIALS AND METHODS: In this randomized clinical trial, 41 patients with diabetes (age 35-67 years) with periodontal disease were recruited and randomly assigned to 4 groups: control (C; n = 12), receiving omega-3 (I1; n = 10, 1 g/ twice daily), cranberry juice (I2; n = 9, 200 ml, twice daily), and cranberry juice enriched with omega-3 (I3; n = 10, 200 ml, containing 1 g omega-3) twice daily for 8 weeks. Nonsurgical periodontal therapy was provided for all patients during the study. Fasting blood glucose and glycated hemoglobin, lipid profile, probing depth, anthropometric indices, and 3-day 24-hour dietary recalls were measured pre- and postintervention. RESULTS: Glycated hemoglobin was decreased significantly in I1 and I3 groups. Serum high-density lipoprotein cholesterol (HDL-C) levels increased significantly in the I3 group compared to baseline and compared to I1 and I2 groups. Probing depth was significantly reduced in all groups postintervention. CONCLUSION: Consumption of cranberry juice enriched with omega-3 can be beneficial as adjuvant therapy with nonsurgical periodontal therapy in decreasing glycated hemoglobin, increasing HDL-C, and improving periodontal status in patients with diabetes with periodontal disease.