Effects of a dietary supplement on digestion and quality of life in adults with functional dyspepsia
Evaluating Changes in Quality of Life and Digestion in Functional Dyspepsia in Adults
This study is testing whether a dietary supplement called Zypan can help adults with functional dyspepsia feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | National University of Natural Medicine Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06320379 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of a dietary supplement called Zypan on the quality of life and digestive symptoms in adults diagnosed with functional dyspepsia. Participants will be randomly assigned to receive either Zypan or a placebo for a duration of four weeks. The study will include adults aged 18 to 70 who report symptoms consistent with functional dyspepsia and have no underlying organic disease. The primary focus is to assess improvements in symptoms and overall well-being resulting from the supplement.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with self-reported symptoms of functional dyspepsia and no organic disease.
Not a fit: Patients with diagnosed organic diseases or those currently taking medications for dyspepsia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary intervention to improve the quality of life for patients suffering from functional dyspepsia.
How similar studies have performed: There is limited information on similar dietary interventions for functional dyspepsia, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. * 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
Where this trial is running
Portland, Oregon
- Helfgott Research Institute — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Ryan Bradley, ND, MPH
- Email: rbradley@nunm.edu
- Phone: 503-502-1862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.