Status:
COMPLETED
Fermented Soy and Heartburn Symptom Relief
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Lallemand Bio-Ingredients
Conditions:
Heartburn
Acid Regurgitation
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. Typically, heartbur...
Detailed Description
Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. Usually it is cause...
Eligibility Criteria
Inclusion
- Able to provide written informed consent in English.
- Willing to have height and weight measured and provide demographic information (e.g. age, race, sex)
- Experience heartburn symptoms at least 2 days a week during the past 3 months.
- Use OTC product(s), supplements, or dietary manipulation to relieve heartburn symptoms in the last 3 months.
- Willing to take the study soy supplement before resorting to OTC product(s) to control heartburn symptoms.
- Willing to complete questionnaires, records, and diaries associated with the study and to complete all clinical visits.
- Willing to provide information about dietary intake; 3-day online 24-hr recalls during baseline, intervention, and washout.
- Willing and able to provide a valid social security for study payment purposes.
Exclusion
- Do not meet the above criteria.
- Soy allergy
- Severe heartburn problem (cannot be ignored and often limits your concentration on daily activities) during the last week
- Diagnosed or currently being treated for any gastrointestinal diseases including GERD, gastric ulcers, Crohn's, celiac, ulcerative colitis, etc.
- Self-disclosed as pregnant or breast-feeding or planning on becoming pregnant during the study duration.
- Currently participating in another clinical study.
Key Trial Info
Start Date :
March 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03867591
Start Date
March 22 2019
End Date
December 31 2019
Last Update
June 9 2020
Active Locations (1)
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1
Food Science and Human Nutrition Department
Gainesville, Florida, United States, 32611