Heartburn Clinical Trial
Official title:
The Effect of Fermented Soy Supplementation on Occasional Heartburn Symptom Relief: A Randomized, Placebo-Controlled, Double-blind Trial
Verified date | June 2020 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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, heartburn symptoms are treated with over-the-counter (OTC) medications which may
come with side effects.
There is suggestive evidence of the efficacy of fermented soy (Gastro-AD®) for the heartburn
symptom relief. The aim of the study is to evaluate the effect of a fermented soy on
heartburn symptom relief and time to onset.
Status | Completed |
Enrollment | 51 |
Est. completion date | December 31, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Food Science and Human Nutrition Department | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Lallemand Bio-Ingredients |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in severity of heartburn symptoms | Severity on a 5-point Likert scale ranging from 1 = no symptoms to 5 = severe discomfort | 5 minutes, 15 minutes, 30 minutes | |
Secondary | Change in Gastrointestinal Symptom Rating Scale (GSRS) | The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. | Baseline; Week 4; Week 5 | |
Secondary | Change in Quality of Life (GERD-QOL) | The GERD-QOL is disease-specific instrument of 16 items combined into domains. | Baseline; Week 4; Week 5 | |
Secondary | Heartburn event frequency | Heartburn events per period | Baseline; Week 4; Week 5 |
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