Fermented Soy and Heartburn Symptom Relief

NCT ID: NCT03867591

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-22
• Study Completion Date: 2019-12-31

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.

Conditions

Heartburn; Acid Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gastro-AD® Group

The participants randomized to this group 1 g of Gastro-AD® powder per sachet + flavoring agents.

Group Type: EXPERIMENTAL

Gastro-AD®

Intervention Type: 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.

Placebo Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lallemand Bio-Ingredients

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy J Dahl, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Food Science and Human Nutrition Department

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201900115

Identifier Type: OTHER

Identifier Source: secondary_id

OCR19814

Identifier Type: -

Identifier Source: org_study_id