Fermented Soy and Heartburn Symptom Relief

NCT03867591 | Completed

• 2 other identifiers: OCR19814IRB201900115
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Heartburn; Acid Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Gastrointestinal Symptom Rating Scale (GSRS)

  Baseline; Week 4; Week 5

• Change in Quality of Life (GERD-QOL)

  Baseline; Week 4; Week 5

• Heartburn event frequency

  Baseline; Week 4; Week 5

Study Arms (2)

Gastro-AD® Group

EXPERIMENTAL

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

Other: Gastro-AD®

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Gastro-AD® 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.

Gastro-AD® Group

Placebo 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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Lallemand Bio-Ingredients: collaborator

Study Sites (1)

Food Science and Human Nutrition Department

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Heartburn

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wendy J Dahl, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 8, 2019
• Study Start: March 22, 2019
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)