Fermented Soy and Heartburn Symptom Relief

• ClinicalTrials.gov Identifier: NCT03867591
• Recruitment Status: Completed
• First Posted: March 8, 2019
• Last Update Posted: June 9, 2020
• Sponsor: University of Florida
• Collaborator: Lallemand Bio-Ingredients
• Information provided by (Responsible Party): University of Florida

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.

Condition or disease	Intervention/treatment	Phase
Heartburn; Acid Regurgitation	Other: Gastro-AD®; Other: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• 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.
• Primary Purpose: Treatment
• Official Title: The Effect of Fermented Soy Supplementation on Occasional Heartburn Symptom Relief: A Randomized, Placebo-Controlled, Double-blind Trial
• Actual Study Start Date: March 22, 2019
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Gastro-AD® Group; The participants randomized to this group 1 g of Gastro-AD® powder per sachet + flavoring agents.	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 Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Change in severity of heartburn symptoms [ Time Frame: 5 minutes, 15 minutes, 30 minutes ]
   Severity on a 5-point Likert scale ranging from 1 = no symptoms to 5 = severe discomfort

Secondary Outcome Measures :

1. Change in Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Baseline; Week 4; Week 5 ]
   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.
2. Change in Quality of Life (GERD-QOL) [ Time Frame: Baseline; Week 4; Week 5 ]
   The GERD-QOL is disease-specific instrument of 16 items combined into domains.
3. Heartburn event frequency [ Time Frame: Baseline; Week 4; Week 5 ]
   Heartburn events per period

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

Food Science and Human Nutrition Department

Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

Lallemand Bio-Ingredients

Investigators

• Principal Investigator: Wendy J Dahl, PhD; University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03867591
• Other Study ID Numbers: OCR19814; IRB201900115 ( Other Identifier: University of Florida )
• First Posted: March 8, 2019
• Last Update Posted: June 9, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Heartburn; Signs and Symptoms, Digestive