Fermented Soy and Heartburn Symptom Relief

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Fermented Soy Supplementation on Occasional Heartburn Symptom Relief: A Randomized, Placebo-Controlled, Double-blind Trial

Conditions
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Heartburn, Acid Regurgitation

Intervention / Treatment
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* Other: Gastro-AD®
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastro-AD® Group<br>The participants randomized to this group 1 g of Gastro-AD® powder per sachet + flavoring agents. | Other: Gastro-AD®<br>* 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.<br>|
| Placebo Comparator: Placebo Group<br>Participants in this arm will take a sachet containing maltodextrin (1 g) and exactly the same flavoring and coloring agents as Gastro-AD® powder flavored sachets. | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Heartburn event frequency | Heartburn events per period | Baseline; Week 4; Week 5 |