Clinical trial NCT04611477: Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals
Official title: A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Synbiotic 365 on Body Composition in Overweight and Obese Individuals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in body mass index (BMI) and the percentage of body fat f
timeFrame: Day 0 (Baseline) to Day 84
Secondary outcomes:
measure: • Total body weight change in comparison to placebo on day 28, 56 and 84, from baseline, as assessed by weighing scale method.
timeFrame: Day 0 (Baseline) to Day 84
measure: • 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.
timeFrame: Day 0 (Baseline) to Day 84
measure: • Change in coronary risk in comparison to placebo on day 84 from baseline.
timeFrame: Day 0 (Baseline) to Day 84
measure: • 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)].
timeFrame: Day 0 (Baseline) to Day 84
measure: • Change in systemic inflammation in comparison to placebo on day 84 from baseline as assessed by hs-CRP test.
timeFrame: Day 0 (Baseline) to Day 84
measure: • 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).
timeFrame: Day 0 (Baseline) to Day 84
measure: • 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.
timeFrame: Day 0 (Baseline) to Day 84
measure: • The change in vital signs monitoring on all the study visits from baseline.
timeFrame: Day 0 (Baseline) to Day 84
measure: • The change in liver and renal safety parameters.
timeFrame: Day 0 (Baseline) to Day 84
measure: • Adverse and serious adverse events recorded during the study duration on IP consumption, as compared to placebo.
timeFrame: Day 0 (Baseline) to Day 84
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Shri Madhumadhav Clinic
state: Maharashtra
Study officials:
affiliation: Shri Madhumadhav Clinic
name: Parag Dr. Salvi, MD
role: PRINCIPAL_INVESTIGATOR
References: