A placebo controlled randomized clinical trial of Crocus sativus L. (saffron) on depression and food craving among overweight women with mild to moderate depression.

WHAT IS KNOWN AND OBJECTIVE: Crocus sativus L., commonly known as saffron, has known anti-depressive properties. However, its effects on food craving and body weight in depressed patients are unknown. Hence, we aimed to evaluate the effects of saffron capsules on food craving, body weight and depression among overweight women with mild and moderate depression compared to the placebo. METHODS: Seventy-three women with BMI ≥ 25 comorbid with mild-to-moderate depression were recruited in this 12-week double-blind, placebo-controlled randomized clinical trial. Participants were randomly assigned into one of the two groups receiving daily either 30 mg of Crocus sativus capsules (15 mg twice/day) or placebo capsules (twice/day). We performed body composition assessments, and beck depression inventory-II at the baseline, and then 2, 4, 8 and 12 weeks later. One month after the participants stopped taking the capsules, weight differences were measured and compared between groups. RESULTS AND DISCUSSION: Fifty-two patients finished the study. The demographic and clinical variables at baseline were the same in two groups. Mean depression scores in the saffron group significantly decreased compared to placebo (mean ± SD: -8.4 score ± 5.9 vs -3.9 ± 5.5; t[50] = 2; P = .007; 95% CI: 1.3-7.7). There was not a significant effect of saffron on food craving using repeated-measures ANOVA, F(1, 29) = 0.38, P = .54. Patients in the saffron group showed fewer side effects. WHAT IS NEW AND CONCLUSION: Saffron capsules were not effective in reducing food craving, but as a safe over-the-counter supplement, it may help reduce the symptoms of depression in patients who experience mild or moderate depression and are overweight.

Omega-3 supplementation effects on body weight and depression among dieter women with co-morbidity of depression and obesity compared with the placebo: A randomized clinical trial.

PURPOSE: We aimed to evaluate the effects of the omega-3 supplementation on body weight and depression among women with co-morbidity of depression and obesity seeking weight reduction compared with the placebo. METHODS: Sixty five patients with co-morbidity of depression and overweight/obesity (BMI ≥ 25) signed the informed consent form and enrolled into this 12-week double-blind, placebo-controlled randomized clinical Trial. Subsequently, participants randomly assigned into one of the two groups receiving daily 6 capsules of omega-3 (each capsule containing 180 mg EPA, and 120 mg DHA) or 6 capsules of placebo (two with each meal). We performed body composition assessments and Beck depression inventory at the baseline, and weeks 2, 4, 8, and 12 after the start of the study. One month after stopping the capsules at the follow-up visit, weight was measured to compare weight relapse between the two groups. RESULTS: Forty five patients finished the study. No significant differences were seen between groups regarding demographic and clinical variables at baseline. Using repeated measures ANOVA, omega-3 significantly reduced depression compared with the placebo (P = 0.05). Mean ± SD weight reduction in omega-3 group 3.07 ± 3.4 kg and in the placebo group was 1.16 ± 2.7 kg and the difference between groups was significant using independent sample t-test (p = 0.049). Patients in the omega-3 group did not show significantly more side effects compared to the placebo but they were not successful in preventing weight regain one month after the end of the study. CONCLUSION: Based on our findings omega-3 capsule as a safe over-the-counter supplement might be helpful in reducing the signs of depression and also body weight in patients with co-morbidity of depression and obesity.

Effects of zinc supplementation in patients with major depression: a randomized clinical trial.

OBJECTIVE: Major depression is a mood disorder that causes changes in physical activity, appetite, sleep and weight. Regarding the role of zinc in the pathology of depression, the present study was aimed to investigate the effects of zinc supplementation in the treatment of this disease. METHODS: This study was a double-blind randomized clinical trial. Forty four patients with major depression were randomly assigned to groups receiving zinc supplementation and placebo. Patients in Zinc group received daily supplementation with 25 mg zinc adjunct to antidepressant; Selective Serotonin Reuptake Inhibitors (SSRIs), while the patients in placebo group received placebo with antidepressants (SSRIs) for twelve weeks. Severity of depression was measured using the Beck Depression Inventory at baseline and was repeated at the sixth and twelfth weeks. ANOVA with repeated measure was used to compare and track the changes during the study. RESULTS: The mean score of Beck test decreased significantly in the zinc supplement group at the end of week 6 (P < 0.01) and 12 (P < 0.001) compared to the baseline. The mean score of Beck Depression Inventory reduced significantly compared to the placebo group at the end of 12th week (P < 0.05). CONCLUSION: The results of the present study indicate that zinc supplementation together with SSRIs antidepressant drug improves major depressive disorders more effectively in patients with placebo plus antidepressants (SSRIs).

Hepatotoxicity of Dorema aucheri (Bilhar) in albino mice.

BACKGROUND: The geographic map of cancer prevalence differs due to environmental and dietary factors in various populations. High prevalence of a number of cancers in some regions is thought to be attributed to local dietary habits. Dorema aucheri (Bilhar) is used commonly as an herbal medicine in some regions including Iran. The aim of this study was to evaluate whether Dorema aucheri has carcinogenic effects in albino mice or not. METHODS: The Dorema aucheri leaves were extracted by Soxhlet method and were injected intraperitoneally and randomly into 28 healthy albino mice which were divided into seven groups. One was put aside as the non-injected control group. The second control group was chosen to be injected by a known carcinogen. Another group was injected by carcinogen and then, Bilhar extract. The left four groups were injected the extracts in a dose- dependent manner, increasingly in the range of 0.4 - 3.2mL/kg. Extract injections were repeated every 48- hour intervals for three times. Then, liver and serum samples were analyzed biochemically and pathologically. RESULTS: The pathologic and biochemical studies showed that the injection of plant extracts caused necrosis, inflammation of the liver tissue, cell proliferation, cholestasis, and there were significant increases in release of liver enzymes [ALP, ALT (SGPT) and AST (SGOT)] and bilirubin compared to the non-injected control group. The level of liver damage was dose dependent. CONCLUSIONS: Dorema aucheri has potential hepatotoxic capacities and possibly this may be related to the high prevalence of cancer in some regions of Iran.

Dietary intake, growth and development of children with ADHD in a randomized clinical trial of Ritalin and Melatonin co-administration: Through circadian cycle modification or appetite enhancement?

OBJECTIVE: It is postulated that ritalin may adversely affect sleep, appetite, weight and growth of some children with ADHD. Therefore, we aimed to evaluate melatonin supplementation effects on dietary intake, growth and development of children with ADHD treated with ritalin through circadian cycle modification and appetite mechanisms. METHOD: After obtaining consent from parents, 50 children aged 7-12 with combined form of AD/HD were randomly divided into two groups based on gender blocks: one received melatonin (3 or 6 mg based on weight) combined with ritalin (1mg/kg) and the other took placebo combined with ritalin (1mg/kg) in a double blind randomized clinical trial. Three-day food record, and standard weight and height of children were evaluated prior to the treatment and 8 weeks after the treatment. Children's appetite and sleep were evaluated in weeks 0, 2, 4 and 8. Hypotheses were then analyzed using SPSS17. RESULTS: Paired sample t-test showed significant changes in sleep latency (23.15±15.25 vs. 17.96±11.66; p=0.047) and total sleep disturbance score (48.84±13.42 vs. 41.30±9.67; p=0.000) before and after melatonin administration, respectively. However, appetite and food intake did not change significantly during the study. Sleep duration and appetite were significantly correlated in melatonin group (Pearson r=0.971, p=0.029). Mean height (138.28±16.24 vs. 141.35±16.78; P=0.000) and weight (36.73±17.82 vs. 38.97±17.93; P=0.005) were significantly increased in melatonin treated children before and after the trial. CONCLUSION: Administration of melatonin along with ritalin improves height and weight growth of children. These effects may be attributed to circadian cycle modification, increasing sleep duration and the consequent more growth hormone release during sleep.