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

Food Selection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565472
• Other study ID #: 1508M77407
• Status: Completed
• Phase: N/A
• First received: September 22, 2015
• Last updated: February 23, 2016
• Start date: October 2015

Study information

• Verified date: February 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Food Selection

Intervention

Other:
• White grape juice

• Apple juice

Locations

Country	Name	City	State
United States	University of Minnesota	St Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gastrointestinal tolerance from baseline	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.	24 hours	No
Secondary	Change in Breath Hydrogen from baseline	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.	2 hours	No