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Fermented Soy and Heartburn Symptom Relief

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03867591
Recruitment Status : Active, not recruiting
First Posted : March 8, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Lallemand Bio-Ingredients
Information provided by (Responsible Party):
University of Florida

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.


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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
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn

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.




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867591


Locations
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United States, Florida
Food Science and Human Nutrition Department
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Lallemand Bio-Ingredients
Investigators
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Principal Investigator: Wendy J Dahl, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03867591     History of Changes
Other Study ID Numbers: OCR19814
IRB201900115 ( Other Identifier: University of Florida )
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms