The Effect of Citrus Beverages on Gastrointestinal Function in Healthy Adults: a Randomized, Double-blind, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Change in Stool Frequency
研究概览
简要总结
The purpose of this study is to evaluate the effect of daily intake of orange pomace on gastrointestinal function as measured by stool frequency. Additional outcomes will include aspects of digestive health, diet quality, and fasting blood glucose and lipid concentrations. Possible explanations for the mechanism of the pomace will be explored in microbial ecology analyses.
详细描述
In this randomized, double-blind, controlled trial, healthy adults will be asked to consume daily servings of orange juice containing either 0 g (n=120; control) or 180 g (i.e. 10 g fiber; n=120) of orange pomace for 3 weeks to assess the effect of the pomace on stool frequency. Blood samples will be obtained to assess the effect of the pomace on metabolic markers. Stool samples will be collected for analyses of the effect of the pomace on fecal bacteria known to be associated with health benefits (e.g., bifidobacteria). For exploratory analyses, additional groups will be asked to consume orange juice containing 90 g of pomace (i.e. 5 g fiber; n=40) or orange-flavored, calorie-matched water (n=40); outcomes from the water group will be compared to those of the 0 g pomace juice group to assess any effects of the juice alone, and outcomes from the 90 g pomace group will be compared to those of the 180 g and 0 g groups in microbiota analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 adults 18-60 years of age
- •Willing and able to consume 16 oz. of a citrus beverage daily for the 3-week study intervention
- •Willing and able to avoid consumption of any orange, grapefruit, tomato or V-8 juice and whole oranges or grapefruits during the two weeks leading up to the study and during the study, not including the study beverage
- •Willing and able to complete daily questionnaires online regarding dietary intake and general health and well-being, including gastrointestinal habits Note: we will recruit participants who will have Internet access for the duration of the protocol, but understand that, once enrolled, situations may change. If this is the case, paper copies of the online forms will be provided
- •Willing to discontinue any prebiotic, probiotic, and fiber supplements after consenting
- •Willing to provide blood via finger prick and a stool sample twice each, once at the beginning and once at the end of the study
排除标准
- •Women who are lactating, know that they are pregnant, or are attempting to get pregnant
- •Currently being treated for any physician-diagnosed diseases or conditions
- •Vegetarians/vegans
研究组 & 干预措施
0 g pomace (control)
16 oz of juice containing 0 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
干预措施: 0 g pomace (control) (Dietary Supplement)
90 g pomace
16 oz of juice containing 90 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
干预措施: 90 g pomace (Dietary Supplement)
180 g pomace
16 oz of juice containing 180 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
干预措施: 180 g pomace (Dietary Supplement)
Flavored water (control)
16 oz of a flavored, calorie-matched water beverage will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
干预措施: Flavored water (control) (Dietary Supplement)
结局指标
主要结局
Change in Stool Frequency
时间窗: Weeks -1,0,1,2,3
The average number of stools per week compared between intervention groups.
次要结局
- Change in Number of bifidobacteria in fecal samples(Change from Weeks 0 and 3)
- Change in Fasting blood glucose(Change from Weeks 0 and 3)
- Change in Reflux symptom score(Change from Weeks -1,0,1,2,3)
- Change in Stool frequency as a function of stool consistency(Change from Weeks -1,0,1,2,3)
- Change in Diarrhea symptom score(Change from Weeks -1,0,1,2,3)
- Change in Constipation symptom score(Change from Weeks -1,0,1,2,3)
- Change in Indigestion symptom score(Change from Weeks -1,0,1,2,3)
- Change in Abdominal pain symptom score(Change from Weeks -1,0,1,2,3)