CTRI/2024/04/065821尚未招募3 期
Evaluating the Efficacy and Safety of Probiotic and Fiber Supplementation in Obese Individuals: A Randomized, Double-Blind, Placebo-Controlled, Multicentric Clinical Study. - NI
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试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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