Effects of Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
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• 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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