Recruiting

ZypanZypan Functional Dyspepsia

Sponsor:

National University of Natural Medicine

Code:

NCT06320379

Conditions

Dyspepsia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Zypan

Placebo Comparator

Study Details

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.

Conditions

Dyspepsia

Study ID

NCT06320379

Start date

Mar 15, 2023

Status verified date

Mar, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Zypan

placebo comparator: Placebo

Interventions

Zypan

The study product is a dietary supplement manufactured by Standard Process Inc (i.e., Zypan®). One serving (i.e., two tablets) contains a proprietary blend (595 mg) of the following: Betaine hydrochloride, bovine pancreas Cytosol™ extract, pepsin (1:10,000), pancreatin (3x), stearic acid (vegetable source), ammonium chloride, bovine spleen, and ovine spleen. Non active ingredients will include cellulose and calcium stearate. Participants will be instructed to take two tablets three times daily with meals

Placebo Comparator

The control supplement will not contain any of the active ingredients in Zypan® and will also be manufactured by Standard Process Inc. Two tablets will contain 435 mg of cellulose (42%), 288 mg rice bran powder (28%), 201 mg of calcium lactate powder (19.5%\*), 103 mg citric acid (10%), and 2.6 mg calcium stearate (0.25%)

Primary outcome measure

Protein Assimilation [ Time Frame: Baseline ]
Protein Assimilation [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Ryan Bradley, ND, MPH

503-502-1862 rbradley@nunm.edu

Anders Gundersen, MS

503-552-1752 agundersen@nunm.edu

Locations

Helfgott Research Institute

Recruiting

Portland, Oregon, United States, 97201

More Information

Sponsor

National University of Natural Medicine

Last update posted

Aug 6, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National University of Natural Medicine on 2024-08-06.