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

NCT02565472 | Completed

• 1 other identifier: 1508M77407
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Selection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Breath Hydrogen from baseline

  2 hours

Study Arms (2)

Apple Juice

EXPERIMENTAL

12 oz apple juice

Other: Apple juice

Grape Juice

EXPERIMENTAL

12 oz grape juice

Other: White grape juice

Interventions

White grape juice OTHER

Grape Juice

Apple juice OTHER

Apple Juice

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 1, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

US (1)