Zypan Functional Dyspepsia

Not Applicable

Recruiting

• Conditions: Dyspepsia

• Registration Number: NCT06320379
• Lead Sponsor: National University of Natural Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-15
• Study First Submitted: 2023-04-03
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.
  • Non-smokers (including tobacco and cannabis products, combusted or vaporized)
  • Willing to provide written informed consent and to follow the required protocol

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)
  • Intake of ≥ 2 standardized alcohol-containing beverages per day, 14 per week, or ≥4 in any single day within the past 14 days.
  • Individuals who do not consume, or are allergic to, animal products
  • Smoking tobacco or nicotine products (combusted or vaporized)
  • Use of illicit drugs/substances (such as but not limited to cocaine, phencyclidine (PCP), and methamphetamine) within 14 days of screening
  • Currently participating in another interventional research study, or participated in another interventional research study within 14 days of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Protein Assimilation	Week 4	Concentrations of Amino Acids in Blood

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale	Week 4	Subjective measure of Quality of life related to physical function
Leeds Dyspepsia Questionnaire	Week 4	Subjective measure of digestive symptoms
Fat-soluble vitamin concentration in blood	Baseline	Fat-soluble vitamin concentrations in blood as measured by Genova Diagnostics NutrEval
Fat-soluble vitamins	Week 4	Fat-soluble vitamin concentrations in blood as measured by Genova Diagnostics NutrEval
Mineral concentrations in blood	Week 4	Mineral concentrations in blood as measured by Genova Diagnostics NutrEval

Trial Locations

Locations (1)

Helfgott Research Institute; 🇺🇸 Portland, Oregon, United States