Evaluating the Efficacy and Safety of Probiotic and Fiber Supplementation in Obese Individuals: A Randomized, Double-Blind, Placebo-Controlled, Multicentric Clinical Study.
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Seven Turns Pvt Ltd
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Anthropometric parameters including body weight (kg), basal
概览
简要总结
The rationale for conducting the proposed study on the efficacy and safety of probiotic and fiber supplementation in obese individuals stems from several key factors: There is growing evidence suggesting that alterations in the gut microbiota composition, known as dysbiosis, may play a role in the development and progression of obesity. Studies have identified differences in the gut microbiota between obese and lean individuals, with specific microbial profiles associated with metabolic health. Probiotics, which are beneficial microorganisms that confer health benefits when consumed, alongside dietary fiber, known for its role in promoting gut health, have both been implicated in modulating the gut microbiota and potentially influencing metabolic outcomes. However, the specific effects of probiotic and fiber supplementation in obese individuals warrant further investigation. While dietary interventions are a cornerstone of obesity management, achieving long-term success remains a challenge for many individuals who struggle to sustain weight loss or experience weight regain over time. Therefore, exploring adjunct therapies such as probiotic and fiber supplementation could offer additional strategies for improving weight management outcomes. Overall, conducting a randomized, placebo-controlled clinical trial to investigate the efficacy and safety of probiotic and fiber supplementation in obese individuals addresses an important gap in the current understanding of obesity management and has the potential to provide valuable insights into optimizing treatment approaches for this prevalent and complex condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and females aged 30-45 years (both inclusive).
- •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.
- •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.
- •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.
- •Participants providing voluntary, written informed consent to participate in the study.
排除标准
- •Participants with BMI values less than or equal to 27.5 and greater than or equal to 40 kg/m2
- •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
- •Participants with comorbidities including but not limited to Type 1 (insulin-dependent) diabetes, polycystic ovary syndrome (PCOS), vascular disease, neurological disease, chronic pain, etc.
- •Participants engaging in frequent strenuous exercise (e.g., marathon running/heavy weight lifting)
- •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
- •Participants with the presence or history of psychiatric illnesses, including eating disorders
- •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
- •Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
- •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
- •Participants with a significant change in usual diet and/or weight loss of more than 4.5 kg in the last 2 months
结局指标
主要结局
1. Anthropometric parameters including body weight (kg), basal
时间窗: At screening, and at day 30, 60, and end of the study
metabolic rate (BMR), BMI, waist and hip circumference, along with
时间窗: At screening, and at day 30, 60, and end of the study
skeletal muscle mass and body fat percentage using bioelectric impedance analysis (BIA)
时间窗: At screening, and at day 30, 60, and end of the study
次要结局
- 1. Biochemical parameters - HbA1c, fasting glucose, post prandial blood glucose and(lipid profile - total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol will be assessed)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre