Use of Probiotics to Aid in Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Percentage of weight loss in post operative gastric bypass patients.
研究概览
简要总结
The purpose of this study is to evaluate the success of daily supplementation of multiple probiotic bacterial cultures over 12 weeks in increasing the percentage of excess weight loss in the RNYGB (Gastric Bypass) weight loss population.
详细描述
Hypothesis
The daily supplementation of a probiotic will increase weight loss compared to a placebo supplement in the post-operative gastric bypass patients.
Study Design:
All patients in this study will be scheduled to undergo the RNYGB (Gastric Bypass) procedure to assist in weight loss. Patients in this study will be randomized to one of two groups: Group 1 (Probiotics) or Group 2 (Placebo). Patients will begin supplementation at the beginning of their 4 week pre-surgery Optifast© 800 diet. All patients will take supplements for a total of 12 weeks. Nutritional education and support will be provided to each patient enrolled in the study. Weight loss will be measured using a machine that measures body composition. All patients will complete a quality of life questionnaire with regard to gastrointestinal health and a hair loss survey pre treatment and at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female at least 18 years of age
- •Signed informed consent
- •Willingness to take a supplement once a day for 12 weeks
- •Undergoing a RNYGB (gastric bypass) procedure
- •Willingness to complete quality of life questionnaire and hair loss survey
排除标准
- •Pregnant Female
- •Lactating Female
- •Male or Female less than 18 years of age
- •Patients on chronic antibiotic treatment (prescribed more than 2 courses of antibiotics over the 12 week study period)
- •Patients who have demonstrated medical therapy non-compliance past or present
结局指标
主要结局
Percentage of weight loss in post operative gastric bypass patients.
时间窗: 12 weeks
Percentage of weight loss will be measured using the The RJL Systems' Quantum IX on all patients for bioelectrical impedance analysis (BIA) to assess human body composition before beginning supplementation and at the end of the 12 week period. The Tanita system will be used as the back-up machine throughout the study as applicable.
次要结局
- Impact of study medication (Probiotics vs. Placebo) on overall Gastrointestinal Health(12 weeks)