Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Other: Synbiotic365 Ver 5; Other: Rice Hulk; Other: Synbiotic365 Ver 7

• Registration Number: NCT04611477
• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-28
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-11-02
• Primary Completion: 2021-10-29
• Study Completion: 2021-10-29
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synbiotic365 Ver 5	Synbiotic365 Ver 5	One capsule/day to be taken orally 30 minutes before breakfast
Placebo	Rice Hulk	One capsule/day to be taken orally 30 minutes before breakfast
Synbiotic365 Ver 7	Synbiotic365 Ver 7	One capsule/day to be taken orally 30 minutes before breakfast

Primary Outcome Measures

Name	Time	Method
Change in body mass index (BMI) and the percentage of body fat f	Day 0 (Baseline) to Day 84	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

Secondary Outcome Measures

Name	Time	Method
• 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.	Day 0 (Baseline) to Day 84
• Change in coronary risk in comparison to placebo on day 84 from baseline.	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)].	Day 0 (Baseline) to Day 84
• The change in liver and renal safety parameters.	Day 0 (Baseline) to Day 84
• Adverse and serious adverse events recorded during the study duration on IP consumption, as compared to placebo.	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.	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).	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.	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.	Day 0 (Baseline) to Day 84
• The change in vital signs monitoring on all the study visits from baseline.	Day 0 (Baseline) to Day 84

Trial Locations

Locations (1)

Shri Madhumadhav Clinic; 🇮🇳 Mumbai, Maharashtra, India