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

Overweight and Obesity Clinical Trial

— Obesity  

Official title:

A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Synbiotic 365 on Body Composition in Overweight and Obese Individuals.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611477
• Other study ID #: NI/190701/SYNBIOTIC365/OO
• Status: Completed
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: October 29, 2021

Study information

• Verified date: September 2020
• Source: Vedic Lifesciences Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Participants meeting ALL of the following criteria will be recruited for the trial:

Inclusion:

1. Male and female participants aged =30 and =60 years.

2. Participants with a BMI in the range of =25 to 34.9 kg/m2.

3. Normal levels of SGOT and SGPT i.e. up to 2.5 times of upper limit of reference range.

4. 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:

1. Individuals having a history of smoking or currently smoking and also using any form of tobacco preparations.

2. Participants diagnosed with type II diabetes mellitus or undiagnosed cases of hyperglycemia with fasting blood sugar > 170 mg/dl.

3. Participants with blood pressure =150 mm Hg (systolic, SBP) and/or = 99 mm Hg (diastolic, DBP)

4. Inability to walk independently

5. History of significant weight instability (defined as > 2 kg of weight loss over last 3 months)

6. Participants currently on diuretics, metformin or thyroid supplements. Presence of unstable, acutely symptomatic, or life-limiting illness.

7. 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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• Rice Hulk
Placebo
• Synbiotic365 Ver 5
Active Comparator
• Synbiotic365 Ver 7
Active Comparator

Locations

Country	Name	City	State
India	Shri Madhumadhav Clinic	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

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