Effect of dry fenugreek seed extract supplements on glycemic indices, lipid pattern, appetite, energy intake and macronutrients, oxidative stress in patients with type 2 diabetes: a double-blind randomized controlled clinical trial

Abstract

Abstract III Keywords: fenugreek, Fenugreek dry extract, Type 2 diabetes, glycemic index, lipid profile, PAB Abstract I at the end of the study, the patients of both groups completed the questionnaires of appetite and desire to eat and 24-hour food diary to assess appetite (in the form of an interview), energy intake and macronutrients. At the beginning and at the end of the intervention, all parameters were evaluated, including indicators related to blood sugar, prooxidant-antioxidant balance (PAB) and lipid profile. Also, food intake and physical activity of subjects were evaluated at the beginning and end of the study using 24-hour food diary and IPAQ questionnaire for physical activity. Statistical analysis of data was done using SPSS 26 software. Results: In the present study, at the end of the study, no significant effect of fenugreek seed extract on glycemic parameters, lipid profile except (HDL) and PAB was observed between the studied groups. But significant effects on insulin, insulin resistance, TG and PAB levels were seen in the intervention group compared to the initial levels. At the end of the study, only the tendency to eat sweet foods among the two groups showed a statistically significant decrease after adjustment based on model 1 (quantile regression analysis with adjustment of baseline values). At the end of the study, after adjusting the baseline values, changes in energy intake and changes in physical activity (model 2), a significant increase in HDL serum levels was observed. Conclusion: Although the present study did not show an obvious and significant effect of fenugreek extract on glycemic and lipid indices and oxidative stress. But these effects may have been revealed with a higher dose, longer study duration, or larger sample size compared to the placebo group. Abstract I Background: continuous increase in blood sugar in uncontrolled diabetes can cause various acute and chronic complications, which is one of the main causes of cardiovascular diseases, blindness, kidney failure, and lower limb amputation. Research on the production of herbal medicines is growing, and in this field, fenugreek (Trigonella foenum-graecum.L.) plays could have a protective role in diabetes. So far, several animal studies have been conducted in the field of improving glycemic status, hyperinsulinemia, appetite and oxidative stress. But since there are limited human studies in this regard and in existing cases, contradictions are observed. In addition, in most of the animal studies, the alcoholic or aqueous extract of fenugreek seeds and sometimes its active ingredients have been used for research on the mentioned cases, but in human diabetes studies, plant seed powder has been used instead of the pure extract. Therefore, the current study aims to determine the effect of dry fenugreek seed extract on oxidant-antioxidant balance (PAB), glycemic status, and appetite in patients with type 2 diabetes. Materials and methods: The present study was conducted as a double-blind randomized clinical trial in patients with T2DM. Initially, based on inclusion and exclusion criteria, 54 patients with T2DM were selected. Then, people were randomly divided into two groups, FDE and placebo. Individuals in the FDE group supplemented with three 335 mg tablets of FDE daily, and those in the control group received three 335 mg tablets of microcrystalline cellulose, along with weight loss diet for 8 weeks in both groups. Before the start of the intervention and also of the study, the patients of both groups completed the questionnaires f