Fermented Soy and Heartburn Symptom Relief

University of Florida51 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heartburn Acid Regurgitation

Interventions

Gastro-AD®OTHER

The product under study is Gastro-AD® fermented soy powder in the form of orodispersible flavored powder packed in non-transparent sachets. Content: 1 g of Gastro-AD® powder per sachet + flavoring agents.

PlaceboOTHER

The placebo product will have very similar appearance, color, texture and taste as the Gastro-AD® flavored sachet. The placebo sachets contain the respective amount of maltodextrin (1 g) and exactly the same flavoring and coloring agents as Gastro-AD® powder flavored sachets.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Food Science and Human Nutrition Department

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Change in severity of heartburn symptoms

Severity on a 5-point Likert scale ranging from 1 = no symptoms to 5 = severe discomfort

Time frame: 5 minutes, 15 minutes, 30 minutes

Secondary Outcomes

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.

Time frame: Baseline; Week 4; Week 5

Change in Quality of Life (GERD-QOL)

The GERD-QOL is disease-specific instrument of 16 items combined into domains.

Time frame: Baseline; Week 4; Week 5

Heartburn event frequency

Heartburn events per period

Time frame: Baseline; Week 4; Week 5

Data from ClinicalTrials.gov

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