Zypan Functional Dyspepsia

NCT06320379 | Recruiting

• 1 other identifier: RB071522
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Protein Assimilation

  Concentrations of Amino Acids in Blood

  Baseline

• Protein Assimilation

  Concentrations of Amino Acids in Blood

  Week 4

Secondary Outcomes (8)

• Mineral concentrations in blood

  Baseline

• Mineral concentrations in blood

  Week 4

• Fat-soluble vitamin concentration in blood

  Baseline

• Fat-soluble vitamins

  Week 4

• Leeds Dyspepsia Questionnaire

  Baseline

Other Outcomes (103)

• Microbiota Relative Abundance and Composition

  Baseline

• Microbiota Relative Abundance and Composition

  Week 4

• Blood glucose

  Baseline

Study Arms (2)

Zypan

EXPERIMENTAL

Dietary Supplement: Zypan

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo Comparator

Interventions

Zypan DIETARY_SUPPLEMENT

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

Zypan

Placebo Comparator DIETARY_SUPPLEMENT

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%)

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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

You may not qualify if:

• ● 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

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

Helfgott Research Institute

Portland, Oregon, 97201, United States

RECRUITING

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ryan Bradley, ND, MPH

CONTACT

503-502-1862; rbradley@nunm.edu

Anders Gundersen, MS

CONTACT

503-552-1752; agundersen@nunm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: Participants will be randomized to take either a placebo or Zypan dietary supplement three times per day for four weeks.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: March 20, 2024
• Study Start: March 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-03

Locations

US (1)