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Fermented Soy and Heartburn Symptom Relief

Primary Purpose

Heartburn, Acid Regurgitation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gastro-AD®

Placebo

About this trial

This is an interventional treatment trial for Heartburn

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Food Science and Human Nutrition Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gastro-AD® Group

Placebo Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in severity of heartburn symptoms

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

Secondary Outcome Measures

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.

Change in Quality of Life (GERD-QOL)

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

Heartburn event frequency

Heartburn events per period

Full Information

NCT ID

NCT03867591

First Posted

March 6, 2019

Last Updated

June 5, 2020

Sponsor

University of Florida

Collaborators

Lallemand Bio-Ingredients

1. Study Identification

Unique Protocol Identification Number

NCT03867591

Brief Title

Fermented Soy and Heartburn Symptom Relief

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

March 22, 2019 (Actual)

Primary Completion Date

June 30, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

Lallemand Bio-Ingredients

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heartburn, Acid Regurgitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

This is a double-blind study; the sponsor representative involved in the study, the investigator, the participants or site personnel involved in participant management or outcome assessment will remain blinded. Blinding to intervention will be used to reduce bias during data collection and evaluation of outcomes. At the investigational site, the randomization codes will remain secure at all times, but may be accessed in the event of an emergency.

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gastro-AD® Group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Gastro-AD®

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in severity of heartburn symptoms

Description

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 Outcome Measure Information:

Title

Change in Gastrointestinal Symptom Rating Scale (GSRS)

Description

Time Frame

Baseline; Week 4; Week 5

Title

Change in Quality of Life (GERD-QOL)

Description

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

Time Frame

Baseline; Week 4; Week 5

Title

Heartburn event frequency

Description

Heartburn events per period

Time Frame

Baseline; Week 4; Week 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wendy J Dahl, PhD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Food Science and Human Nutrition Department

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Fermented Soy and Heartburn Symptom Relief

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