Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals
Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals
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).
Participants meeting ALL of the following criteria will be recruited for the trial:

 -  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 willing to abstain from the restricted supplements and medications prior
 to inclusion and throughout the study period.

 -  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.

 -  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.

 -  Use of any psychotropic medication such as monoamine oxidase (MAO) inhibitors,
 anxiolytics, mood stabilizers, stimulants, etc. throughout the study.

 -  Exposure to any non-registered drug product within 3 months prior to the screening
 visit.

 -  Participants currently using or having a history of herbal/nutraceutical supplements
 usage for weight loss in last 3 months.

 -  Participants currently on vitamin supplements will be rescreened after a washout
 period of 2 weeks.

 -  Females who are pregnant/planning to be pregnant/lactating or taking any oral
 contraceptives.

 -  Participants with heavy alcohol consumption, defined as

 -  For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a
 day.

 -  For women: More than 7 SAD/week or more than 3 SAD in a day.

 -  Binge drinkers, defined as 4 or more SAD for women, and 5 or more SAD for men, in a
 2-hour time frame.