Fermented Soy and Heartburn Symptom Relief

Heartburn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867591
• Other study ID #: OCR19814
• Secondary ID: IRB201900115
• Status: Completed
• Phase: N/A
• Start date: March 22, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acid Regurgitation
• Heartburn

Intervention

Other:
• Gastro-AD®
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	Food Science and Human Nutrition Department	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Lallemand Bio-Ingredients

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Heartburn event frequency	Heartburn events per period	Baseline; Week 4; Week 5