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

University of Minnesota40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Food Selection

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Secondary Outcomes

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.

Time frame: 2 hours