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Completed

NCT Number: NCT02565472

Effects of Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects

The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of two types of juice. This double-blind crossover study requires participants to arrive to the lab 12 hours fasted, consume 12 oz of juice and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over the next 3 hours. Subjects will be asked to complete additional questionnaires at 12 and 24 hours post consumption, from home. Subjects will also be asked to keep a food record for 24 hours prior to their scheduled visit times to assure compliance.

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Key information

Conditions

Food Selection Behavior Feeding Behavior Food Preferences

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between the ages of 18-65 Body mass index between 18-29 kg/m2 Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures

Exclusion criteria

  • • Use of enemas, laxatives, proton pump inhibitors, or antibiotics within the past 3 months
  • Smoker
  • Not a regular breakfast or eater
  • Self-reported history of a past or current gastrointestinal disease
  • High fiber eater (≥3 servings of high fiber foods per day)
  • Concurrent or recent (within 30 days) participation in an intervention trial
  • Recent weight fluctuations
  • Allergies to any of the test products

Treatment and study plan

White grape juice

Other

Apple juice

Other

Primary outcomes

  1. Change in gastrointestinal tolerance from baseline

    Time frame: 24 hours

    Subjects will answer a 7 symptom questionnaire regarding the intensity of gastrointestinal symptoms experienced following juice consumption. Questionnaire is adapted from the validated Bovenschen gastrointestinal tolerance questionnaire. Questionnaire is to be completed at the following time points: baseline, 30 min, 60 min, 90 min, 120 min, 180 min, 12 hours, 24 hours.

Secondary outcomes

  1. Change in Breath Hydrogen from baseline

    Time frame: 2 hours

    Patients will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron BreathTracker Analyzer at time points: baseline, 60 min, 120 min. This will be a marker of carbohydrate fermentation in the colon.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Effect of a White Grape Juice Compared to Apple Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects

Important dates

Study start
2015
Primary completion
2015
First posted
Oct 1, 2015
Registry last updated
Feb 24, 2016

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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