Fermented Soy and Heartburn Symptom Relief
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|ClinicalTrials.gov Identifier: NCT03867591|
Recruitment Status : Active, not recruiting
First Posted : March 8, 2019
Last Update Posted : July 24, 2019
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|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.|
|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|
Experimental: Gastro-AD® Group
The participants randomized to this group 1 g of Gastro-AD® powder per sachet + flavoring agents.
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.
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.
- 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
- 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.
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
|United States, Florida|
|Food Science and Human Nutrition Department|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Wendy J Dahl, PhD||University of Florida|