A Randomized, Double-Blind, Placebo-Controlled, Multicentric Clinical Study: Evaluating the Efficacy and Safety of Probiotic and Fiber Supplementation in Obese Individuals.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Anthropometric parameters including body weight (kg), basal metabolic
研究概览
简要总结
The rationale for conducting the proposed study on the efficacy and safety of probiotic and fiber supplementation in obese individuals compared with an isolated dietary intervention stem from several key factors:
There is growing evidence suggesting that alterations in the gut microbiota composition (dysbiosis), may play a role in the development and progression of obesity. Studies have shown differences in the gut microbiota between obese and lean individuals, with specific microbial profiles associated with metabolic health.
Probiotics, beneficial microorganisms that confer health benefits when consumed, and 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, long-term success is often challenging to achieve. Many individuals 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.
Moreover, Evaluating the safety of probiotic and fiber supplementation alongside dietary interventions is essential particularly in obesity management where individuals may have underlying health conditions or be taking multiple medications. If probiotic and fiber supplementation are found to be effective and safe adjuncts to dietary interventions, they could be incorporated into obesity treatment protocols, offering patients additional options for achieving and maintaining weight loss.
Overall, conducting a randomized, placebo-controlled clinical trial to investigate the efficacy and safety of probiotic and fiber supplementation in obese individuals compared with isolated dietary intervention 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.
90 days intervention results
Methods: Obese adults (Body Mass Index (BMI 30-<40 kg/m², aged 30-45, male: 46.15% female 53.85%) were randomly assigned to receive either the probiotic-fiber blend formulation or a placebo for 90 days, along with lifestyle counseling. Primary outcomes included body weight, BMI, waist/hip circumference, and body fat percentage. Secondary outcomes assessed biochemical parameters, digestive health, quality of life, perceived stress, and Metabolic Syndrome Severity Z (MetS Z) score. 104 participants completed the study.
Results: The probiotic-fiber blend formulation demonstrated statistically significant (p < 0.001) improvements compared to placebo, including reductions in body weight (12.01%), BMI (12.14%), waist circumference (9.64%), and hip circumference (9.63%) compared to placebo. Additionally, statistically significant reductions were observed in MetS Z score (54.02%), triglycerides (25.75%), and perceived stress (37.62%), along with a notable increase in HDL levels (16.55%). Significant improvements in digestive health and quality of life were also recorded, reinforcing the probiotic-fiber blend efficacy.
Conclusion: The findings provide robust evidence that the probiotic-fiber blend effectively improves anthropometric and biochemical markers in obesity. These results underscore the therapeutic potential of gut microbiome modulation in metabolic health. Further research should explore long-term effects, mechanistic pathways, and broader clinical applications.
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 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.
- •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 plasma 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 30 and greater than 40 kg/m
- •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.
- •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
- •Participants with the presence or history of psychiatric illnesses, including eating disorders
- •Participants with a family history of obesity
- •Participants using phytoherbal supplements, dietary, nutraceuticals, allopathic, or ayurvedic supplements for weight loss;
- •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
- •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
- •Participants enrolled in another obesity treatment program and those who, in the investigator’s opinion, are unable to complete the study.
- •Participants with evidence or history of malignancy; 16.
结局指标
主要结局
Anthropometric parameters including body weight (kg), basal metabolic
时间窗: At screening, and at day 30, 60, and end of the study
rate (BMR), BMI, waist and hip circumference, along with skeletal muscle
时间窗: At screening, and at day 30, 60, and end of the study
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 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)
研究者
Dr Manohar KN
Sharada Medical Centre