Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
A randomized placebo controlled trial to determine if increased dietary fiber will prevent weight gain, inhibit adiposity and reduce perceived stress levels in residents at the Waco Family Health Center as the result of changes in distal gut microbiota composition and function.
详细描述
This study will utilize a single blind, placebo controlled, parallel design to assess the effect of dietary fiber [Prebiotin] on the gut microbiome, perceived stress, anthropometric variables, and clinical biomarkers of metabolism. All participants in this study will be resident physicians at the Family Health Center in Waco, TX. This population was selected based on pilot data indicating they are at a greater risk for weight gain and have higher levels of stress than the average population. The goal is to recruit 40 participants for a 12 week intervention trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently a resident in training at the Family Health Center in their first year.
排除标准
- •Pregnancy
- •Currently on prescribed metformin or NSAIDS
- •A diagnosed gastro-intestinal disease (i.e. irritable bowel syndrome or Crohn's disease)
- •Known allergy to the supplement, placebo, or provided meal replacements
- •Antibiotic use within the last 3 months.
研究组 & 干预措施
Placebo
Dietary Supplement: Placebo
干预措施: Prebiotin (Dietary Supplement)
Prebiotin
Dietary Supplement: Prebiotin (oligofructose enriched inulin)
干预措施: Prebiotin (Dietary Supplement)
结局指标
主要结局
Change in body weight
时间窗: 12 weeks
The investigators will use the following procedure to assess the effect of Prebiotin (OEI) on changes in body weight: there will be two test days: a) baseline (Day 0), prior to randomization to OEI or placebo; and b) week 12, following the 11 week course of OEI/placebo treatment. The investigators will use OEI for the inulin challenge. Change in body weight will be quantified by bio electrical impedance.
次要结局
未报告次要终点
研究者
Leigh Greathouse
Assistant Professor of Nutrition Sciences
Baylor University