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

Study Overview
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Brief Summary
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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.

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

Conditions
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Food Selection

Intervention / Treatment
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* Other: White grape juice
* Other: Apple juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apple Juice<br>12 oz apple juice | Other: Apple juice<br> <br> |
| Experimental: Grape Juice<br>12 oz grape juice | Other: White grape juice<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |