The Effect of Orange or Apple Pomace on Digestive Health in Adults: a Randomized, Double Blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- stool frequency
研究概览
简要总结
This is a randomized crossover intervention designed to evaluate effects of daily intake of beverages containing orange or apple Pomace on gastrointestinal function as measured by stool frequency. Additional outcomes will include aspects of digestive health and self-reported GI symptoms and dietary intake as well as analysis of gut microbiota.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females 18-60 years old
- •Willing and able to consume 16 oz. of orange or apple beverage per day for 4 week periods
- •Willing to maintain usual diet, smoking status, physical activity pattern, supplements and meds
排除标准
- •Food allergies or sensitivities to ingredients in study beverages
- •Presence or history of GI condition, endocrine (including diabetes), cardiovascular disease or other disease or condition that could interfere in the interpretation of the study results in the opinion of the Investigator.
- •Extreme dietary habits including vegetarian, vegan or Atkins diet
- •Females or are pregnant, planning to become pregnant or breast feeding during the study period.
研究组 & 干预措施
Orange juice only
16 oz. orange juice per day for 4 weeks
干预措施: Orange Juice (Other)
orange juice + orange Pomace
16 oz. orange juice + orange Pomace per day for 4 weeks
干预措施: Orange juice + Orange Pomace (Other)
Apple juice only
16 oz. apple juice per day for 4 weeks
干预措施: Apple Juice (Other)
Apple Juice + Apple Pomace
16 oz. apple juice + apple Pomace per day for 4 weeks
干预措施: Apple Juice and Apple Pomace (Other)
结局指标
主要结局
stool frequency
时间窗: Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
Bowel habits daily diary as weekly averages. Fewer days with no stool, and higher number of stools per week would be better.
次要结局
- Self-reported GI symptoms(Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in))
- microbiota changes(Changes from baseline sample to end of treatment sample (Week 4) and end of 3 week washout sample (Week 7))
- Dietary analysis(Changes from 2 week run in (baseline) to the last week of treatment (Week 4) and the last week of 3 week washout (Week 7))
- Stool consistency(Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in))
- Ease of stool passage(Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in))