Fiber's Utilization for Energy and Life
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Metabolizable Energy of the Diet
研究概览
简要总结
The study aims to evaluate the metabolizable energy of the typical American diet with and without the inclusion of fiber. We hypothesize that including fiber in the diet will decrease the metabolizable energy of the diet resulting in more nutrient loss into the feces and urine.
详细描述
The study will be a randomized, crossover, controlled feeding trial comprised of 2 experimental periods: 1) control and 2) fiber. Each experimental condition will be 16 days in length. There will be at least a 12-day compliance break between each period. Participants will undergo complete urine and fecal collection for a period five to seven days during the second half of each experimental condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ages 22-75 years
- •BMI between 18.5 and 39.9 kg/m2
- •Ability to drop-off 1 fecal sample within 15 minutes of defecation
- •Ability to pick-up meals daily
- •Ability to collect fecal and urine samples daily
- •Fasting glucose of <126 mg/dL
排除标准
- •Wheat allergy or intolerance
- •Any food allergies or intolerances
- •Prior diagnosis of metabolic or gastrointestinal disease (kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, diabetes requiring medication)
- •Women that are pregnant, had a baby within the last 12 months, or are lactating.
- •Individuals that smoke, use tobacco, abuse drugs, or consume > 2 alcoholic beverages per day.
- •>5% weight change in the past month or >10% change in the past year
- •Oral antibiotics during the previous 6 weeks
- •History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery
- •Are unable or unwilling to consume the experimental meals/snacks.
- •Taking certain medications (Orlistat, bile binding resins, insulin, oral hypoglycemic agents, laxatives)
- •Concurrent enrollment in another dietary, exercise, or medication study
结局指标
主要结局
Metabolizable Energy of the Diet
时间窗: during the last 5 days of the 2 week intervention period
The diets provided to participants will be analyzed for their energy and proximate analysis. Fecal and urine samples will be collected for 5 days during week 2 of each intervention period to calculate the total metabolizable energy of the diet. Energy and proximate analysis (dry matter, organic matter, crude protein, acid-hydrolyzed fat, and total dietary fiber) will be analyzed from the provided diet and the fecal samples. Energy will be analyzed from urine samples. The metabolizable energy content will be calculated according to the methods of Novotny et al. (2012), which considers the energy of the diet compared to the remaining energy in the collected fecal and urine samples.
次要结局
- Fecal Microbiota(end of week 2 (end of intervention period))