Evaluating the efficacy and safety of probiotic and fiber supplementation in obese individuals a single arm clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
Emerging evidence suggests that alterations in gut microbiota composition, known as dysbiosis, may significantly contribute to the development and progression of obesity. Research has highlighted distinct differences in the gut microbiota of obese versus lean individuals, with certain microbial profiles being closely linked to metabolic health. Probiotics and dietary fibers are well-documented for their roles in promoting gut health and modulating the gut microbiota, potentially influencing metabolic outcomes.
Probiotics, which are beneficial microorganisms, confer health benefits when consumed, and dietary fiber is known for its crucial role in gut health. Despite their potential, the specific effects of combined probiotic and fiber supplementation in obese individuals require further investigation. Conventional dietary interventions remain the cornerstone of obesity management; however, long-term success is often elusive due to challenges in sustaining weight loss and preventing weight regain. Therefore, exploring adjunct therapies such as probiotic and fiber supplementation offers a promising strategy to enhance weight management outcomes.
This study aims to evaluate the long-term effects of consuming a combined probiotic and fiber supplement over a 180-day period, specifically focusing on whether consistent use of the product affects gut microbiota diversity and overall metabolic health. Concurrently, a placebo-controlled study over three months will be conducted to observe short-term weight management outcomes. By comparing these two approaches, we aim to gather comprehensive data on both the immediate and sustained impacts of the supplementation.
Key objectives include assessing the influence of the supplementation on gut microbiota diversity, metabolic health, and various anthropometric parameters. The safety profile of the supplementation, alongside dietary interventions, is also a critical focus, particularly considering the potential underlying health conditions and polypharmacy often seen in obese individuals.
Conducting this single-arm clinical trial will provide valuable insights into the long-term efficacy and safety of probiotic and fiber supplementation. If proven effective and safe, this approach could be integrated into obesity management protocols, offering patients additional tools for achieving and maintaining weight loss. This study addresses a significant gap in current obesity treatment strategies and has the potential to contribute to the development of more effective and sustainable obesity management interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 Class I (BMI between 30 and less than 35 kg/m²) and Class II (BMI between 35 and less than40 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) –a.serum triglycerides greater than or equal to 150 mg/dL.b.HDL cholesterol less than or equal to 40 mg/dL in men, less than or equal to 50 mg/dL in women.c.blood pressure greater than or equal to 130 mmHg systolic or greater than or equal to 85 mmHg diastolic.d.fasting plasma glucose greater than or equal to 100 mg/dL.e.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 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.
- •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.
- •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 investigator’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.
结局指标
主要结局
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)
时间窗: At screening, day 45, day 90, day 135 and Day 180.
次要结局
- The secondary objectives of the study will be to evaluate the impact of the probiotic & fiber supplementation on biochemical parameters, digestive health, quality of life, perceived stress levels, metabolic health, overall improvement, GLP-1 level, microbiome diversity, & safety assessment through monitoring adverse events, vital signs, tolerability, & compliance throughout the study.(From Screening to day 180.)
研究者
Dr Manohar KN
Sharada Medical Centre