Fermented Soy and Heartburn Symptom Relief
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 3/31/2019 |
| Start Date: | March 22, 2019 |
| End Date: | December 31, 2019 |
| Contact: | Wendy J Dahl, PhD |
| Email: | wdahl@ufl.edu |
| Phone: | 352-294-3707 |
The Effect of Fermented Soy Supplementation on Occasional Heartburn Symptom Relief: A Randomized, Placebo-Controlled, Double-blind Trial
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.
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.
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 caused by the regurgitation of gastric acid into the esophagus. The prevalence
of heartburn is 10-20% worldwide and is increasing. Typically, heartburn symptoms are treated
with over-the-counter (OTC) medications which may come with side effects.
Gastro-AD® is a commercially available food supplement produced by fermentation of soy by a
specific strain of Lactobacillus. There is suggestive evidence, in vivo as well as in vitro
studies, 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. It is hypothesized that the consumption of 1-3 g of fermented soy will relieve
the heartburn symptom severity.
typically manifests as a painful burning sensation in the upper abdomen or in the chest.
Usually it is caused by the regurgitation of gastric acid into the esophagus. The prevalence
of heartburn is 10-20% worldwide and is increasing. Typically, heartburn symptoms are treated
with over-the-counter (OTC) medications which may come with side effects.
Gastro-AD® is a commercially available food supplement produced by fermentation of soy by a
specific strain of Lactobacillus. There is suggestive evidence, in vivo as well as in vitro
studies, 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. It is hypothesized that the consumption of 1-3 g of fermented soy will relieve
the heartburn symptom severity.
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
- Diagnosed or currently being treated for any gastrointestinal diseases including GERD,
gastric ulcers, Crohn's, celiac, ulcerative colitis, etc.
- Use of prescription medication(s) in the last month preceding randomization (oral
contraceptives and medications for anxiety, depression and mood will be permitted)
- Self-disclosed as pregnant or breast-feeding or planning on becoming pregnant during
the study duration.
- Currently participating in another clinical study.
We found this trial at
1
site
Click here to add this to my saved trials
