Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Group A: The Good Bug Metabolically Lean + The Good Bug Metabolic
Fiber Boost with nutritional counselling and tracking.: 1 sachet of The Good Bug Metabolically Lean (3g) + 1 scoop (8g
Sponsors
Seven Turns Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and females aged 30-45 years (both inclusive).2. Participants with BMI greater than or equal to 27.5 kg/m2, with significant weight gain (at least 10 kg) in the last three years.3. Participants with at least three of the following metabolic syndrome criteria (NCEP ATP III) – serum triglycerides greater than or equal to 150 mg/dL, HDL cholesterol: less than or equal to 40 mg/dL in men, less than or equal to 50 mg/dL in women, blood pressure: greater than or equal to 130 mmHg systolic or greater than or equal to 85 mmHg diastolic, fasting blood glucose greater than or equal to 100 mg/dL, Abdominal obesity, waist circumference: Men greater than 90 cm; Women greater than 80 cm.4. Participants with the absence of any diet or medication that might interfere with metabolic homeostasis and gut microbiota, especially oral/IV antibiotics and/or probiotics 3 months before recruitment.5. Participants providing voluntary, written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Participants with BMI values less than or equal to 27.5 and greater than or equal to 40 kg/m2 2. Participants with fasting blood glucose greater than 180 mg/dL, postprandial blood glucose greater than 250 mg/dL, triglycerides greater than 500 mg/ dL, TSH levels less than 0.5 & greater than 4.5 mIU/L and blood pressure greater than 155/100 mmHg 3. Participants with comorbidities including but not limited to Type 1 (insulin-dependent) diabetes, polycystic ovary syndrome (PCOS), vascular disease, neurological disease, chronic pain, etc. 4. Participants engaging in frequent strenuous exercise (e.g., marathon running/heavy weight lifting) 5. Participants who have undergone surgery in the last 6 months including but not limited to angioplasty, abdominal surgeries (including weight loss surgery) or partial/complete resection of stomach or bowel 6. Participants with the presence or history of psychiatric illnesses, including eating disorders 7. Participants using medications such as high doses of vitamin D, fiber supplements known to affect hunger/satiety/appetite/gut microbiome or currently using blood thinners 8. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study 9. Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1/2 pack per day 10. Participants with a significant change in usual diet and/or weight loss of more than 4.5 kg in the last 2 months 11. Participants with chronic bowel diseases, severe immunosuppression 12. Participants enrolled in another obesity treatment program and those who, in the investigator’s opinion, are unable to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Anthropometric parameters including body weight (kg), basal metabolic rate (BMR), BMI, waist and hip circumference, along with skeletal muscle mass and body fat percentage using bioelectric impedance analysis (BIA)Timepoint: At screening, and at day 30, 60, and end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biochemical parameters - HbA1c, fasting glucose, post prandial blood glucose and lipid profile - total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol will be assessed 2. Digestive health symptoms - acidity, bloating, bowel movements, cravings, hunger and satiety as per self-assessment questionnaire score using a 4-point ordinal scale and 11-point numerical rating scale 3. Impact of Weight on Quality of Life-Lite (IWQOL-Lite) score 4. Perceived stress scale-10 (PSS-10) score 5. Metabolic Syndrome Severity Z Score (MetZ score) 6. Thyroid stimulating hormone (TSH) level 7. Clinical global impression–improvement scaleTimepoint: 1. At screening and the end of the study. 2. At screening, day 30, 60, and end of the study 3. At screening and end of the study 4. At screening, and end of the 5. At screening and end of the study (Day 90) 6. At screening and the end of the study 7. At the end of the study | — |
Countries
India
Contacts
Public ContactKaynat Mirajkar
Seven Turns Pvt. Ltd.
Outcome results
None listed