Evaluating Changes in Quality of Life and Digestion in Functional Dyspepsia in Adults

National University of Natural Medicine1 site in 1 country64 target enrollmentMarch 15, 2023

ConditionsDyspepsia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dyspepsia
Sponsor: National University of Natural Medicine
Enrollment: 64
Locations: 1
Primary Endpoint: Protein Assimilation
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the effects of a readily available dietary supplement on quality of life and digestion in adults with functional dyspepsia.

Registry

clinicaltrials.gov

Start Date

March 15, 2023

End Date

December 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National University of Natural Medicine

Responsible Party

Principal Investigator

Ryan Bradley

Director of Research

National University of Natural Medicine

Eligibility Criteria

Inclusion Criteria

•● Adults 18-70 years of age (inclusive)
•A self-reported history of symptoms consistent with Functional Dyspepsia (per Rome IV criteria - See Telephone Screening), and self-reported absence of organic disease and infection (e.g., Helicobacter pylori) with or without a formal diagnosis by a healthcare professional.
•Adults ≥ 60 years of age must have had a normal upper gastrointestinal endoscopy
•Willing to be randomized to take a daily dietary supplement or placebo over the 4-week study period
•Not taken antibiotics or other drugs prescribed specifically for symptoms consistent with Functional Dyspepsia (per Rome IV criteria) for a period up to 1 month before the beginning of the study.
•On a stable dose of all medications prior to study entry (i.e., consistent dose for a minimum of three months)
•On a stable dose of dietary supplements for at least one month prior to enrollment
•Willing to avoid initiation of new supplements and/or medications unless otherwise indicated by a healthcare professional
•Able to communicate via email, complete computer-administered questionnaires, and to read and write in English.
•Approved to be eligible for study participation at the discretion of the Principal Investigators, after review of the Formal Eligibility Screen results.

Exclusion Criteria

•● A self-reported history of peptic and/or duodenal ulcers, H. pylori infection, gastroesophageal reflux disease (GERD) explained by upper endoscopy, irritable bowel syndrome (IBS), and other chronic GI disorders.
•Positive fecal occult blood test (FOBT) at the clinical screening visit
•Current use of digestive enzyme and/or betaine HCL-containing dietary supplements
•Current use of prescribed proton-pump inhibitors
•Current use of drugs that interfere with gastrointestinal motility, including prokinetic agents.
•History of previous abdominal surgery, including gastric surgery, excluding appendectomy.
•Individuals with chronic kidney or liver disease, cancer, colorectal disease and/or other rare disorders that at the discretion of the PI or Clinical Investigator may impact their safety or confound trial results
•Current involvement or within 14 days prior to screening of a significant diet or weight loss program (such as NutriSystem, Jenny Craig, Atkin's or other low-carb diet programs) or very low-calorie liquid diet programs (such as Optifast, Medifast, and/or HMR)
•Hospitalization (for any reason other than a scheduled medical procedure unrelated to Functional Dyspepsia) within 3 months prior to screening
•Malignancy within the last 5 years (with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix)

Outcomes

Primary Outcomes

Protein Assimilation

Time Frame: Week 4

Concentrations of Amino Acids in Blood

Secondary Outcomes

Mineral concentrations in blood(Week 4)
Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale(Week 4)
Leeds Dyspepsia Questionnaire(Week 4)
Fat-soluble vitamin concentration in blood(Baseline)
Fat-soluble vitamins(Week 4)