Citrus Beverages and Gastrointestinal Function
POM
The Effect of Citrus Beverages on Gastrointestinal Function in Healthy Adults: a Randomized, Double-blind, Controlled Clinical Trial
1 other identifier
interventional
330
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Feb 2017
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2016
CompletedFirst Posted
Study publicly available on registry
December 1, 2016
CompletedStudy Start
First participant enrolled
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2017
CompletedOctober 16, 2018
October 1, 2018
3 months
November 29, 2016
October 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Stool Frequency
The average number of stools per week compared between intervention groups.
Weeks -1,0,1,2,3
Secondary Outcomes (8)
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 Reflux symptom score
Change from Weeks -1,0,1,2,3
- +3 more secondary outcomes
Study Arms (4)
0 g pomace (control)
OTHER16 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).
90 g pomace
EXPERIMENTAL16 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).
180 g pomace
EXPERIMENTAL16 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).
Flavored water (control)
OTHER16 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).
Interventions
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)
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).
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).
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- PepsiCo, Inc.collaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32611, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Bobbi Langkamp-Henken, PhD, RD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2016
First Posted
December 1, 2016
Study Start
February 13, 2017
Primary Completion
April 29, 2017
Study Completion
April 29, 2017
Last Updated
October 16, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share