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

NCT04611477 | Completed

• 1 other identifier: NI/190701/SYNBIOTIC365/OO
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• • 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 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

• • 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

One capsule/day to be taken orally 30 minutes before breakfast

Other: Rice Hulk

Synbiotic365 Ver 5

ACTIVE COMPARATOR

One capsule/day to be taken orally 30 minutes before breakfast

Other: Synbiotic365 Ver 5

Synbiotic365 Ver 7

ACTIVE COMPARATOR

One capsule/day to be taken orally 30 minutes before breakfast

Other: Synbiotic365 Ver 7

Interventions

Rice Hulk OTHER

Placebo

Placebo

Synbiotic365 Ver 5 OTHER

Active Comparator

Synbiotic365 Ver 5

Synbiotic365 Ver 7 OTHER

Active Comparator

Synbiotic365 Ver 7

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Alkaline Phosphatase i.e. up to 1.5 times of upper limit of reference range
• \. 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..
• \. Participants willing to complete all the study procedures including study-related questionnaires and comply with the study requirements.
• \. Participants ready to give voluntary, written, informed consent to participate in the study.
• \. Participants willing to continue the same diet and exercise regime throughout the study period.

You may not qualify if:

• 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.
• Unwillingness or inability to be randomized to any one of the three intervention groups.
• Continuous participation in randomly assigned lifestyle intervention program for six months.
• Bilateral hip replacements.
• Unable to give consent.
• Known cases of hypothyroidism.
• Abnormal TSH value, out of reference range (\<0.4μIU/mL and \> 4.0μIU/mL).
• Females with the history of irregular menses or any other gynecological disorder such as (polycystic ovarian syndrome (PCOS), hormonal disturbances, etc).
• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (1)

Shri Madhumadhav Clinic

Mumbai, Maharashtra, 400025, India

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Parag Dr. Salvi, MD

  Shri Madhumadhav Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: November 2, 2020
• Study Start: September 28, 2020
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: February 2, 2022

Record last verified: 2020-09

Locations

IN (1)