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

NCT ID: NCT02565472

Last Updated: 2016-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

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.

Detailed Description

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Conditions

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Food Selection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Apple Juice

12 oz apple juice

Group Type EXPERIMENTAL

Apple juice

Intervention Type OTHER

Grape Juice

12 oz grape juice

Group Type EXPERIMENTAL

White grape juice

Intervention Type OTHER

Interventions

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White grape juice

Intervention Type OTHER

Apple juice

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1508M77407

Identifier Type: -

Identifier Source: org_study_id

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