Dyspepsia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTZypan
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
DIETARY_SUPPLEMENTPlacebo 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%)
Sponsors
National University of Natural Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized to take either a placebo or Zypan dietary supplement three times per day for four weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protein Assimilation | Baseline | Concentrations of Amino Acids in Blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mineral concentrations in blood | Baseline | Mineral concentrations in blood as measured by Genova Diagnostics NutrEval |
| 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 |
| Leeds Dyspepsia Questionnaire | Baseline | Subjective measure of digestive symptoms |
| Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale | Baseline | Subjective measure of Quality of life related to physical function |
Other
| Measure | Time frame | Description |
|---|---|---|
| Potassium | Baseline | blood concentrations of Potassium |
| Chloride | Baseline | blood concentrations of Chloride |
| Carbon Dioxide | baseline | blood concentration of carbon dioxide |
| Calcium | Baseline | blood concentration of calcium |
| Total Protein | Baseline | Total protein in blood |
| Albumin | Baseline | Concentration of albumin in blood |
| Globulin | baseline | Concentration of globulin in blood |
| Albumin to Globulin ratio | Baseline | Ratio of the blood concentrations of albumin to globulin |
| Bilirubin | baseline | Concentrations of bilirubin in blood |
| Alkaline Phosphatase | baseline | Concentrations of alkaline phosphatase in blood |
| aspartate aminotransferase | Baseline | Concentrations of aspartate aminotransferase in blood |
| Alanine aminotransferase | baseline | Concentrations of Alanine aminotransferase in blood |
| Estimated glomerular filtration rate | baseline | glomerular filtration rate per 1.73 sqM estimated |
| White blood cell count | baseline | Amount of leukocytes in blood |
| Red blood cell count | baseline | Amount of erythrocytes in blood |
| Hemoglobin | baseline | Amount of hemoglobin in blood |
| Hematocrit | baseline | Amount of hematocrit in blood |
| Mean corpuscular volume | baseline | Mean corpuscular volume of erythrocytes |
| Mean corpuscular hemoglobin | baseline | Mean corpuscular hemoglobin of erythrocytes |
| Mean corpuscular hemoglobin concentration | baseline | Mean corpuscular hemoglobin concentration of erythrocytes |
| Erythrocyte distribution width | baseline | Erythrocyte distribution width |
| Platelet count | baseline | amount of platelets in blood |
| Neutrophils | baseline | amount of neutrophils in blood |
| Band Neutrophils | baseline | Neutrophils band form per 100 leukocytes |
| Absolute band neutrophils | baseline | Amount of Neutrophils band form |
| Metamyelocytes | baseline | Amount of metamyelocytes per 100 leukocytes |
| Absolute Metamyelocytes | baseline | Amount of metamyelocytes |
| Myelocytes | baseline | Amount of metamyelocytes per 100 leukocytes |
| Absolute Myelocytes | baseline | Amount of myelocytes |
| Promyelocytes | baseline | Amount of promyelocytes per 100 leukocytes |
| Absolute Promyelocytes | baseline | Amount of promyelocytes |
| Absolute Neutrophils | baseline | Amount of neutrophils in blood |
| Lymphocytes | baseline | Amount of lymphocytes in blood per 100 leukocytes |
| Reactive Lymphocytes | baseline | Amount of reactive lymphocytes in blood per 100 leukocytes |
| Absolute Lymphocytes | baseline | Amount of reactive lymphocytes in blood |
| Monocytes | baseline | Amount of monocytes in blood per 100 leukocytes |
| Absolute monocytes | baseline | Amount of monocytes in blood |
| Eosinophils | baseline | Amount of eosinophils in blood per 100 leukocytes |
| Absolute Eosinophils | baseline | Amount of eosinophils in blood |
| Basophils | baseline | Amount of basophils in blood per 100 leukocytes |
| Absolute Basophils | baseline | Amount of basophils in blood |
| Blasts | baseline | Amount of blasts in blood per 100 leukocytes |
| Absolute Blasts | baseline | Amount of blasts in blood |
| Nucleated red blood cells | baseline | Amount of nucleated erythrocytes per 100 leukocytes |
| Microbiota Relative Abundance and Composition | Baseline | Objective measure of amount and types of gut microbes |
| Platelet mean volume | baseline | Mean volume of platelets in blood |
| Absolute Nucleated red blood cells | baseline | Amount of nucleated erythrocytes in blood |
| Blood glucose | Baseline | Blood concentrations of glucose |
| Urea Nitrogen | Baseline | Blood concentrations of Urea Nitrogen |
| Creatinine | Baseline | Blood concentrations of creatinine |
| Urea Nitrogen to creatinine ratio | baseline | ratio of blood concentrations of urea nitrogen to creatinine |
| Sodium | Baseline | blood concentrations of Sodium |
Countries
United States
Contacts
Primary ContactRyan Bradley, ND, MPH
Backup ContactAnders Gundersen, MS
Outcome results
None listed