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 (2.011g) + 1 scoop
Sponsors
Seven Turns Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and females aged 30-45 years (both inclusive).2. Participants with Class I (BMI between 30 and less than 35 kg/m²) and Class II (BMI between 35 and less. than 40 kg/m²) obesity, who have experienced significant weight gain (at least 10 kg) over the past three years.3. Participants with at least three of the following metabolic syndrome criteria (NCEP ATP III)â??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 plasma 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 30 and greater than 40 kg/m2. 2. Participants with fasting plasma glucose greater than 180 mg/dL, postprandial plasma 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, chronic liver disease, kidney disease or cardiovascular diseases 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 with a family history of obesity 8. Participants using phytoherbal supplements, dietary, nutraceuticals, allopathic, or ayurvedic supplements for weight loss; 9. Participants using any weight loss supplements like high doses of vitamin D or GLP-1 analogs, fiber supplements known to affect hunger/satiety/appetite/gut microbiome or currently using blood thinners 10. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study 11. 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 12. Participants with a significant change in usual diet and/or weight loss of more than 4.5 kg in the last 2 months 13. Participants with bowel diseases including irritable bowel syndrome & inflammatory bowel disease, severe immunosuppression. 14. Participants enrolled in another obesity treatment program and those who, in the investigatorâ??s opinion, are unable to complete the study. 15. Participants with evidence or history of malignancy; 16. Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 like HbA1c, fasting plasma glucose, post-prandial plasma glucose & lipid profile (total cholesterol, triglycerides, LDL cholesterol, & HDL cholesterol) will be assessed. 2. Digestive health symptoms such as acidity, bloating, bowel movements, cravings, hunger & satiety as per self-assessment questionnaire score using a 4-point ordinal scale & 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 impressionâ??improvement scale scoreTimepoint: 1. At screening & the end of the study 2. At screening, day 30, 60, & end of the study 3. At screening & the end of the study 4. At screening & the end of the study 5. At screening & the end of the study (Day 90) 6. At screening & 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