Fermented Soy and Heartburn Symptom Relief

Completed · Not applicable · Has a placebo group

Conditions studied: Heartburn, Acid Regurgitation

In brief

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.

Key facts

Study ID

NCT03867591

Run by

University of Florida

People needed

51

Starts

2019-03-22

Expected to finish

2019-12-31

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Food Science and Human Nutrition Department — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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