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

Not Applicable

Completed

• Conditions: Food Selection
• Interventions: Other: White grape juice; Other: Apple juice

• Registration Number: NCT02565472
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-30
• Study Start: 2015-10
• Study First Posted: 2015-10-01
• Primary Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Grape Juice	White grape juice	12 oz grape juice
Apple Juice	Apple juice	12 oz apple juice

Primary Outcome Measures

Name	Time	Method
Change in gastrointestinal tolerance from baseline	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 Outcome Measures

Name	Time	Method
Change in Breath Hydrogen from baseline	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 St Paul, Minnesota, United States