Evaluate the effect of Synbiotic 365 (Version 5 and 7) on body composition in overweight and obese individuals as measured by change in body mass index (BMI) and the percentage of body fat from Day 0 to Day 84 when compared to placebo by Dual Energy X-ray Absorptiometry scan (DEXA) for body composition (Body Mass Index, Lean Body Mass, Body Fat, Fat Free Mass).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
180
Placebo
Active Comparator
Active Comparator
Shri Madhumadhav Clinic
Mumbai, Maharashtra, India
Change in body mass index (BMI) and the percentage of body fat f
To investigate the effect of Synbiotic 365 (Version 5 and 7) on body composition in overweight and obese individuals as measured by change in body mass index (BMI) and the percentage of body fat from Day 0 to Day 84 when compared to placebo by Dual Energy X-ray Absorptiometry scan (DEXA) for body composition
Time frame: Day 0 (Baseline) to Day 84
• Total body weight change in comparison to placebo on day 28, 56 and 84, from baseline, as assessed by weighing scale method.
Time frame: Day 0 (Baseline) to Day 84
• Change in central obesity in comparison to placebo on day 28, 56 and 84, from baseline as assessed by the anthropometric index of waist-to-hip ratio.
Time frame: Day 0 (Baseline) to Day 84
• Change in coronary risk in comparison to placebo on day 84 from baseline.
Time frame: Day 0 (Baseline) to Day 84
• Change in blood glucose metabolism in comparison to placebo on day 84 from baseline as assessed by HOMA-IR [(fasting Glucose x fasting Insulin) /405)].
Time frame: Day 0 (Baseline) to Day 84
• Change in systemic inflammation in comparison to placebo on day 84 from baseline as assessed by hs-CRP test.
Time frame: Day 0 (Baseline) to Day 84
• Change in health-related quality of life (HRQL) scores in comparison to placebo on day 28, 56 and 84 from baseline, as assessed by Gastrointestinal Quality of Life Index (GIQLI).
Time frame: Day 0 (Baseline) to Day 84
• Change in satiety in comparison to placebo on day 28, 56 and 84, from baseline as assessed by the Three-Factor Eating Questionnaire (TFEQ) for satiety.
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Time frame: Day 0 (Baseline) to Day 84
• The change in vital signs monitoring on all the study visits from baseline.
Time frame: Day 0 (Baseline) to Day 84
• The change in liver and renal safety parameters.
Time frame: Day 0 (Baseline) to Day 84
• Adverse and serious adverse events recorded during the study duration on IP consumption, as compared to placebo.
Time frame: Day 0 (Baseline) to Day 84