Zypan Functional Dyspepsia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia
• Intervention / Treatment: Dietary supplement: Zypan; Dietary supplement: Placebo Comparator

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ryan Bradley, ND, MPH; Phone Number: 503-502-1862; Email: rbradley@nunm.edu
• Study Contact Backup: Name: Anders Gundersen, MS; Phone Number: 503-552-1752; Email: agundersen@nunm.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97201
      • Recruiting
      • Helfgott Research Institute
      • Contact: Anders Gundersen, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: 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%)
Experimental: Zypan	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein Assimilation	Concentrations of Amino Acids in Blood	Baseline
Protein Assimilation	Concentrations of Amino Acids in Blood	Week 4

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota Relative Abundance and Composition	Objective measure of amount and types of gut microbes	Baseline
Microbiota Relative Abundance and Composition	Objective measure of microbiota abundance, composition, diversity	Week 4
Blood glucose	Blood concentrations of glucose	Baseline
Blood glucose	Blood concentrations of glucose	Week 4
Urea Nitrogen	Blood concentrations of Urea Nitrogen	Baseline
Urea Nitrogen	Blood concentrations of Urea Nitrogen	Week 4
Creatinine	Blood concentrations of creatinine	Baseline
Creatinine	Blood concentrations of creatinine	Week 4
Urea Nitrogen to creatinine ratio	ratio of blood concentrations of urea nitrogen to creatinine	baseline
Urea Nitrogen to creatinine ratio	ratio of blood concentrations of urea nitrogen to creatinine	Week 4
Sodium	blood concentrations of Sodium	Baseline
Sodium	blood concentrations of Sodium	Week 4
Potassium	blood concentrations of Potassium	Baseline
Potassium	blood concentrations of Potassium	Week 4
Chloride	blood concentrations of Chloride	Baseline
Chloride	blood concentrations of Chloride	Week 4
Carbon Dioxide	blood concentration of carbon dioxide	baseline
Carbon Dioxide	blood concentration of carbon dioxide	week 4
Calcium	blood concentration of calcium	Baseline
Calcium	blood concentration of calcium	Week 4
Total Protein	Total protein in blood	Baseline
Total Protein	Total protein in blood	Week 4
Albumin	Concentration of albumin in blood	Baseline
Albumin	Concentration of albumin in blood	Week 4
Globulin	Concentration of globulin in blood	baseline
Globulin	Concentration of globulin in blood	Week 4
Albumin to Globulin ratio	Ratio of the blood concentrations of albumin to globulin	Baseline
Albumin to Globulin ratio	Ratio of the blood concentrations of albumin to globulin	Week 4
Bilirubin	Concentrations of bilirubin in blood	baseline
Bilirubin	Concentrations of bilirubin in blood	Week 4
Alkaline Phosphatase	Concentrations of alkaline phosphatase in blood	baseline
Alkaline Phosphatase	Concentrations of alkaline phosphatase in blood	Week 4
aspartate aminotransferase	Concentrations of aspartate aminotransferase in blood	Baseline
aspartate aminotransferase	Concentrations of aspartate aminotransferase in blood	Week 4
Alanine aminotransferase	Concentrations of Alanine aminotransferase in blood	baseline
Alanine aminotransferase	Concentrations of Alanine aminotransferase in blood	Week 4
Estimated glomerular filtration rate	glomerular filtration rate per 1.73 sqM estimated	baseline
Estimated glomerular filtration rate	glomerular filtration rate per 1.73 sqM estimated	Week 4
White blood cell count	Amount of leukocytes in blood	baseline
White blood cell count	Amount of leukocytes in blood	Week 4
Red blood cell count	Amount of erythrocytes in blood	baseline
Red blood cell count	Amount of erythrocytes in blood	Week 4
Hemoglobin	Amount of hemoglobin in blood	baseline
Hemoglobin	Amount of hemoglobin in blood	Week 4
Hematocrit	Amount of hematocrit in blood	baseline
Hematocrit	Amount of hematocrit in blood	Week 4
Mean corpuscular volume	Mean corpuscular volume of erythrocytes	baseline
Mean corpuscular volume	Mean corpuscular volume of erythrocytes	Week 4
Mean corpuscular hemoglobin	Mean corpuscular hemoglobin of erythrocytes	baseline
Mean corpuscular hemoglobin	Mean corpuscular hemoglobin of erythrocytes	Week 4
Mean corpuscular hemoglobin concentration	Mean corpuscular hemoglobin concentration of erythrocytes	baseline
Mean corpuscular hemoglobin concentration	Mean corpuscular hemoglobin concentration of erythrocytes	Week 4
Erythrocyte distribution width	Erythrocyte distribution width	baseline
Erythrocyte distribution width	Erythrocyte distribution width	Week 4
Platelet count	amount of platelets in blood	baseline
Platelet count	amount of platelets in blood	Week 4
Neutrophils	amount of neutrophils in blood	baseline
Neutrophils	amount of neutrophils in blood	Week 4
Band Neutrophils	Neutrophils band form per 100 leukocytes	baseline
Band Neutrophils	Neutrophils band form per 100 leukocytes	Week 4
Absolute band neutrophils	Amount of Neutrophils band form	baseline
Absolute band neutrophils	Amount of Neutrophils band form	Week 4
Metamyelocytes	Amount of metamyelocytes per 100 leukocytes	baseline
Metamyelocytes	Amount of metamyelocytes per 100 leukocytes	Week 4
Absolute Metamyelocytes	Amount of metamyelocytes	baseline
Absolute Metamyelocytes	Amount of metamyelocytes	Week 4
Myelocytes	Amount of metamyelocytes per 100 leukocytes	baseline
Myelocytes	Amount of metamyelocytes per 100 leukocytes	Week 4
Absolute Myelocytes	Amount of myelocytes	baseline
Absolute Myelocytes	Amount of myelocytes	Week 4
Promyelocytes	Amount of promyelocytes per 100 leukocytes	baseline
Promyelocytes	Amount of promyelocytes per 100 leukocytes	Week 4
Absolute Promyelocytes	Amount of promyelocytes	baseline
Absolute Promyelocytes	Amount of promyelocytes	Week 4
Absolute Neutrophils	Amount of neutrophils in blood	baseline
Absolute Neutrophils	Amount of neutrophils in blood	Week 4
Lymphocytes	Amount of lymphocytes in blood per 100 leukocytes	baseline
Lymphocytes	Amount of lymphocytes in blood per 100 leukocytes	Week 4
Reactive Lymphocytes	Amount of reactive lymphocytes in blood per 100 leukocytes	baseline
Reactive Lymphocytes	Amount of reactive lymphocytes in blood per 100 leukocytes	Week 4
Absolute Lymphocytes	Amount of reactive lymphocytes in blood	baseline
Absolute Lymphocytes	Amount of reactive lymphocytes in blood	Week 4
Monocytes	Amount of monocytes in blood per 100 leukocytes	baseline
Monocytes	Amount of monocytes in blood per 100 leukocytes	Week 4
Absolute monocytes	Amount of monocytes in blood	baseline
Absolute monocytes	Amount of monocytes in blood	Week 4
Eosinophils	Amount of eosinophils in blood per 100 leukocytes	baseline
Eosinophils	Amount of eosinophils in blood per 100 leukocytes	Week 4
Absolute Eosinophils	Amount of eosinophils in blood	baseline
Absolute Eosinophils	Amount of eosinophils in blood	Week 4
Basophils	Amount of basophils in blood per 100 leukocytes	baseline
Basophils	Amount of basophils in blood per 100 leukocytes	Week 4
Absolute Basophils	Amount of basophils in blood	baseline
Absolute Basophils	Amount of basophils in blood	Week 4
Blasts	Amount of blasts in blood per 100 leukocytes	baseline
Blasts	Amount of blasts in blood per 100 leukocytes	Week 4
Absolute Blasts	Amount of blasts in blood	baseline
Absolute Blasts	Amount of blasts in blood	Week 4
Nucleated red blood cells	Amount of nucleated erythrocytes per 100 leukocytes	baseline
Absolute Nucleated red blood cells	Amount of nucleated erythrocytes in blood	baseline
Absolute Nucleated red blood cells	Amount of nucleated erythrocytes in blood	Week 4
Platelet mean volume	Mean volume of platelets in blood	baseline
Platelet mean volume	Mean volume of platelets in blood	Week 4

Collaborators and Investigators

• Sponsor: National University of Natural Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: RB071522

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No