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Completed

NCT Number: NCT02979496

Citrus Beverages and Gastrointestinal Function

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

0 g pomace (control)

Dietary Supplement

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)

90 g pomace

Dietary Supplement

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).

180 g pomace

Dietary Supplement

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).

Flavored water (control)

Dietary Supplement

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).

Primary outcomes

  1. Change in Stool Frequency

    Time frame: Weeks -1,0,1,2,3

    The average number of stools per week compared between intervention groups.

Secondary outcomes

  1. Change in Stool frequency as a function of stool consistency

    Time frame: Change from Weeks -1,0,1,2,3

    The average number of stools per week compared between intervention groups, including Bristol Stool Score category (stool types 1-7 with 1 = hard and 7 = liquid ) as a covariate in the statistical model.

  2. Change in Diarrhea symptom score

    Time frame: Change from Weeks -1,0,1,2,3

    Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.

  3. Change in Constipation symptom score

    Time frame: Change from Weeks -1,0,1,2,3

    Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.

  4. Change in Indigestion symptom score

    Time frame: Change from Weeks -1,0,1,2,3

    Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.

  5. Change in Reflux symptom score

    Time frame: Change from Weeks -1,0,1,2,3

    Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.

  6. Change in Abdominal pain symptom score

    Time frame: Change from Weeks -1,0,1,2,3

    Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.

  7. Change in Number of bifidobacteria in fecal samples

    Time frame: Change from Weeks 0 and 3

    Bifidobacteria in fecal samples will be quantified via quantitative polymerase chain reaction (qPCR) and compared between groups.

  8. Change in Fasting blood glucose

    Time frame: Change from Weeks 0 and 3

    Fasting blood glucose determined by Cholestech assay

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • PepsiCo, Inc.

Registry information

Official study title

The Effect of Citrus Beverages on Gastrointestinal Function in Healthy Adults: a Randomized, Double-blind, Controlled Clinical Trial

Acronym: POM

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2016
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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