Effect of two doses of Fenugreek flakes (fenuleantm) on appetite, body-weight and blood glucose homeostasis: A randomized, double-blind, multicenter, three-arm, long-term, control study in 100 healthy subjects
S Mehkri, C Ambarish, BJ Madankumar, Preethi Shivayogi, Krathish Bopanna
Introduction: Dietary fiber, more importantly soluble fiber finds its way into nutrition to be combined with functional foods1. The active study products for this study contained Fenu Lean TM - Fenugreek Flakes (FF) 5g and 10g. Both FF study products are proprietary products of Bio-gen Extracts Pvt. Ltd., Bangalore, India. The study products are de-fatted and de-bitterized having a high fiber content of ≥ 50% of which 20% are soluble fibers and 30% are insoluble fibers. In addition, they also have a protein content of ≥ 20%2. The method of extraction and formulation of the product are intended to maximize the health benefits that Fenugreek Flakes (FF) can bring to the consumer at large. Here, the study products were assessed for their effects on appetite scores, secondary changes to blood glucose, change in body weight, BMI and serum insulin levels3. Methods: A double-blind, randomized, three-arm, parallel study to evaluate the efficacy and safety of Fenu Lean TM - Fenugreek Flakes (FF), n=100. The study had two active arms with dosages of 5g and 10g of Fenugreek Flakes (FF) versus the third control arm. The study sample population included 100 subjects, 45 subjects in each of the two active arms and 10 subjects in the control arm where no intervention was given. The primary assessment of appetite scores, secondary changes to blood glucose, body weight, BMI and serum insulin levels were measured at baseline and at each of the visits through the duration of study. Results: This study established positive effect of the two doses of Fenu Lean TM - Fenugreek Flakes (FF) on subjective assessment of appetite scores using Visual Analogue Scale (VAS) scale, changes in body weight, BMI and measurements of glucose homeostasis in subjects falling within the body mass index (BMI) ≥18 to ≤29.9 kg/m.2 The study was also able to show a significant reduction in fasting glucose and post prandial glucose for the duration of treatment period specifically in both the FF groups that was not observed in the control group across the study visits. There were no significant changes noted in serum insulin parameters in the study. Conclusions: This study established the fact that supplementation with FF under normal dietary conditions (without any restrictions) decreased energy intake through reduction in hunger, feeling of fullness and feeling of satiety at the end of forty-five days of supplementation or treatment.Consumption of Fenugreek Flakes (5g and 10g) over the duration of study treatments were able to demonstrate a linear relationship of dose dependency effect of FF on appetite scores and reduction in body weight and BMI.