Fermented Soy and Heartburn Symptom Relief

Not Applicable

Completed

• Conditions: Heartburn; Acid Regurgitation

• Registration Number: NCT03867591
• Lead Sponsor: University of Florida

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, 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.

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 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.

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-08
• Study Start: 2019-03-22
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in severity of heartburn symptoms	5 minutes, 15 minutes, 30 minutes	Severity on a 5-point Likert scale ranging from 1 = no symptoms to 5 = severe discomfort

Secondary Outcome Measures

Name	Time	Method
Change in Gastrointestinal Symptom Rating Scale (GSRS)	Baseline; Week 4; Week 5	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.
Heartburn event frequency	Baseline; Week 4; Week 5	Heartburn events per period
Change in Quality of Life (GERD-QOL)	Baseline; Week 4; Week 5	The GERD-QOL is disease-specific instrument of 16 items combined into domains.

Trial Locations

Locations (1)

Food Science and Human Nutrition Department; 🇺🇸 Gainesville, Florida, United States