Health Condition 1: E660- Obesity due to excess calories
Conditions
Interventions
Intervention1: Test Group
Plix Apple Cider Vinegar Effervescent tablets plus Diet and exercise recommendations: 2 tablets per day to be taken. 1 Tablet 30 mins before lunch and 1 Tablet 30 mins befor
Sponsors
Plix Life
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntary women and or men from 18 years to 55 years of age, willing to lose weight. 2. With the body mass index (BMI) of more than 25 kg/m2 (range 25– 3. Subjects not on any nutritional supplement or not consuming any therapeutic medication for any disorder for last 45 days. 4. Subjects with no known allergies to foods & other substances 5. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 6. Having signed a Consent Form, after being informed orally and in writing of all information concerning the study procedures and study objectives. 7. Willingness to avoid intense UV exposure as far as possible for the entire study duration.
Exclusion criteria
Exclusion criteria: 1. Pregnant women by UPT /lactating women. 2. Subjects showing abnormal levels in blood test parameters. (Subjects having abnormal values but are Clinically fit to participate in the trial would be enrolled in the study at Principal Investigator’s Discretion). 3. Subjects regularly taking ACV for the past 1 month. 4. Having conditions like thyroid, diabetes, gastrointestinal diseases or any kind of infections. 5. Any clinically significant systemic disease, which may interfere with study treatments or procedures. 6. Subjects with substance abuse (alcohol, drugs). 7. Subject likely to undergo any surgery in the period of the study. 8. Subjects who were on any other experimental Investigational study within last 1 month as identified during screening on visit 1 (V1). 9. Individuals with chronic Gastrointestinal issues such as frequent indigestion, bloating, acidity or GERD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Plix Program (Plix Apple Cider Vinegar Effervescent tablets, diet, exercise) on weight management, Visceral Adiposity Index & lipid profile in obese1 subjects versus baseline & placebo. Timepoint: Screening, Day 0, 1 month, 2 month, 3 month | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the in-use tolerance of the product.Timepoint: Screening, Day 0, 1 month, 2 month, 3 month | — |
Countries
India
Contacts
Public ContactMs Preetha Paul
C.L.A.I.M.S. Pvt. Ltd.
Outcome results
None listed