- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04611477
Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals (Obesity)
A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Synbiotic 365 on Body Composition in Overweight and Obese Individuals.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maharashtra
-
Mumbai, Maharashtra, India, 400025
- Shri Madhumadhav Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Participants meeting ALL of the following criteria will be recruited for the trial:
Inclusion:
- Male and female participants aged ≥30 and ≤60 years.
- Participants with a BMI in the range of ≥25 to 34.9 kg/m2.
- Normal levels of SGOT and SGPT i.e. up to 2.5 times of upper limit of reference range.
- Normal level of Creatinine i.e. up to 1.5 times of upper limit of reference range.
5 Alkaline Phosphatase i.e. up to 1.5 times of upper limit of reference range
6. Participants having At least 3 of the following five metabolic risk factors: i. Waist circumference: Men: ≥ 102 cm (40.15 inches); Women ≥88 cm (34.65 inches) ii. Triglycerides levels >150 mg/dL iii. Blood pressure ≥130 mm Hg (systolic, SBP) and/or ≥85 mm Hg(diastolic, DBP); iv. Fasting blood glucose ≥ 100 mg/ dL v. Low HDL level: Men: < 40 mg/dL; Women: < 50 mg/dL..
7. Participants willing to complete all the study procedures including study-related questionnaires and comply with the study requirements.
8. Participants willing to abstain from the restricted supplements and medications prior to inclusion and throughout the study period.
9. Participants ready to give voluntary, written, informed consent to participate in the study.
10. Participants willing to continue the same diet and exercise regime throughout the study period.
Exclusion:
- Individuals having a history of smoking or currently smoking and also using any form of tobacco preparations.
- Participants diagnosed with type II diabetes mellitus or undiagnosed cases of hyperglycemia with fasting blood sugar > 170 mg/dl.
- Participants with blood pressure ≥150 mm Hg (systolic, SBP) and/or ≥ 99 mm Hg (diastolic, DBP)
- Inability to walk independently
- History of significant weight instability (defined as > 2 kg of weight loss over last 3 months)
- Participants currently on diuretics, metformin or thyroid supplements. Presence of unstable, acutely symptomatic, or life-limiting illness.
- Any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
8 Unwillingness or inability to be randomized to any one of the three intervention groups.
9 Continuous participation in randomly assigned lifestyle intervention program for six months.
10 Bilateral hip replacements.
11 Unable to give consent.
12 Known cases of hypothyroidism.
13 Abnormal TSH value, out of reference range (<0.4μIU/mL and > 4.0μIU/mL).
14 Females with the history of irregular menses or any other gynecological disorder such as (polycystic ovarian syndrome (PCOS), hormonal disturbances, etc).
15 History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic disorders, that in the judgment of the investigator, would interfere with the participant's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
One capsule/day to be taken orally 30 minutes before breakfast
|
Placebo
|
ACTIVE_COMPARATOR: Synbiotic365 Ver 5
One capsule/day to be taken orally 30 minutes before breakfast
|
Active Comparator
|
ACTIVE_COMPARATOR: Synbiotic365 Ver 7
One capsule/day to be taken orally 30 minutes before breakfast
|
Active Comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body mass index (BMI) and the percentage of body fat f
Time Frame: 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
|
Day 0 (Baseline) to Day 84
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
• 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
|
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
|
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
|
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
|
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
|
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
|
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.
Time Frame: Day 0 (Baseline) to Day 84
|
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
|
Day 0 (Baseline) to Day 84
|
• The change in liver and renal safety parameters.
Time Frame: Day 0 (Baseline) to Day 84
|
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
|
Day 0 (Baseline) to Day 84
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Parag Dr. Salvi, MD, Shri Madhumadhav Clinic
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI/190701/SYNBIOTIC365/OO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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