Clinical trial NCT06320379: Zypan Functional Dyspepsia
Official title: Evaluating Changes in Quality of Life and Digestion in Functional Dyspepsia in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyspepsia
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to take either a placebo or Zypan dietary supplement three times per day for four weeks.
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Protein Assimilation
timeFrame: Baseline
measure: Protein Assimilation
timeFrame: Week 4
Secondary outcomes:
measure: Mineral concentrations in blood
timeFrame: Baseline
measure: Mineral concentrations in blood
timeFrame: Week 4
measure: Fat-soluble vitamin concentration in blood
timeFrame: Baseline
measure: Fat-soluble vitamins
timeFrame: Week 4
measure: Leeds Dyspepsia Questionnaire
timeFrame: Baseline
measure: Leeds Dyspepsia Questionnaire
timeFrame: Week 4
measure: Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale
timeFrame: Baseline
measure: Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale
timeFrame: Week 4
Other outcomes:
measure: Microbiota Relative Abundance and Composition
timeFrame: Baseline
measure: Microbiota Relative Abundance and Composition
timeFrame: Week 4
measure: Blood glucose
timeFrame: Baseline
measure: Blood glucose
timeFrame: Week 4
measure: Urea Nitrogen
timeFrame: Baseline
measure: Urea Nitrogen
timeFrame: Week 4
measure: Creatinine
timeFrame: Baseline
measure: Creatinine
timeFrame: Week 4
measure: Urea Nitrogen to creatinine ratio
timeFrame: baseline
measure: Urea Nitrogen to creatinine ratio
timeFrame: Week 4
measure: Sodium
timeFrame: Baseline
measure: Sodium
timeFrame: Week 4
measure: Potassium
timeFrame: Baseline
measure: Potassium
timeFrame: Week 4
measure: Chloride
timeFrame: Baseline
measure: Chloride
timeFrame: Week 4
measure: Carbon Dioxide
timeFrame: baseline
measure: Carbon Dioxide
timeFrame: week 4
measure: Calcium
timeFrame: Baseline
measure: Calcium
timeFrame: Week 4
measure: Total Protein
timeFrame: Baseline
measure: Total Protein
timeFrame: Week 4
measure: Albumin
timeFrame: Baseline
measure: Albumin
timeFrame: Week 4
measure: Globulin
timeFrame: baseline
measure: Globulin
timeFrame: Week 4
measure: Albumin to Globulin ratio
timeFrame: Baseline
measure: Albumin to Globulin ratio
timeFrame: Week 4
measure: Bilirubin
timeFrame: baseline
measure: Bilirubin
timeFrame: Week 4
measure: Alkaline Phosphatase
timeFrame: baseline
measure: Alkaline Phosphatase
timeFrame: Week 4
measure: aspartate aminotransferase
timeFrame: Baseline
measure: aspartate aminotransferase
timeFrame: Week 4
measure: Alanine aminotransferase
timeFrame: baseline
measure: Alanine aminotransferase
timeFrame: Week 4
measure: Estimated glomerular filtration rate
timeFrame: baseline
measure: Estimated glomerular filtration rate
timeFrame: Week 4
measure: White blood cell count
timeFrame: baseline
measure: White blood cell count
timeFrame: Week 4
measure: Red blood cell count
timeFrame: baseline
measure: Red blood cell count
timeFrame: Week 4
measure: Hemoglobin
timeFrame: baseline
measure: Hemoglobin
timeFrame: Week 4
measure: Hematocrit
timeFrame: baseline
measure: Hematocrit
timeFrame: Week 4
measure: Mean corpuscular volume
timeFrame: baseline
measure: Mean corpuscular volume
timeFrame: Week 4
measure: Mean corpuscular hemoglobin
timeFrame: baseline
measure: Mean corpuscular hemoglobin
timeFrame: Week 4
measure: Mean corpuscular hemoglobin concentration
timeFrame: baseline
measure: Mean corpuscular hemoglobin concentration
timeFrame: Week 4
measure: Erythrocyte distribution width
timeFrame: baseline
measure: Erythrocyte distribution width
timeFrame: Week 4
measure: Platelet count
timeFrame: baseline
measure: Platelet count
timeFrame: Week 4
measure: Neutrophils
timeFrame: baseline
measure: Neutrophils
timeFrame: Week 4
measure: Band Neutrophils
timeFrame: baseline
measure: Band Neutrophils
timeFrame: Week 4
measure: Absolute band neutrophils
timeFrame: baseline
measure: Absolute band neutrophils
timeFrame: Week 4
measure: Metamyelocytes
timeFrame: baseline
measure: Metamyelocytes
timeFrame: Week 4
measure: Absolute Metamyelocytes
timeFrame: baseline
measure: Absolute Metamyelocytes
timeFrame: Week 4
measure: Myelocytes
timeFrame: baseline
measure: Myelocytes
timeFrame: Week 4
measure: Absolute Myelocytes
timeFrame: baseline
measure: Absolute Myelocytes
timeFrame: Week 4
measure: Promyelocytes
timeFrame: baseline
measure: Promyelocytes
timeFrame: Week 4
measure: Absolute Promyelocytes
timeFrame: baseline
measure: Absolute Promyelocytes
timeFrame: Week 4
measure: Absolute Neutrophils
timeFrame: baseline
measure: Absolute Neutrophils
timeFrame: Week 4
measure: Lymphocytes
timeFrame: baseline
measure: Lymphocytes
timeFrame: Week 4
measure: Reactive Lymphocytes
timeFrame: baseline
measure: Reactive Lymphocytes
timeFrame: Week 4
measure: Absolute Lymphocytes
timeFrame: baseline
measure: Absolute Lymphocytes
timeFrame: Week 4
measure: Monocytes
timeFrame: baseline
measure: Monocytes
timeFrame: Week 4
measure: Absolute monocytes
timeFrame: baseline
measure: Absolute monocytes
timeFrame: Week 4
measure: Eosinophils
timeFrame: baseline
measure: Eosinophils
timeFrame: Week 4
measure: Absolute Eosinophils
timeFrame: baseline
measure: Absolute Eosinophils
timeFrame: Week 4
measure: Basophils
timeFrame: baseline
measure: Basophils
timeFrame: Week 4
measure: Absolute Basophils
timeFrame: baseline
measure: Absolute Basophils
timeFrame: Week 4
measure: Blasts
timeFrame: baseline
measure: Blasts
timeFrame: Week 4
measure: Absolute Blasts
timeFrame: baseline
measure: Absolute Blasts
timeFrame: Week 4
measure: Nucleated red blood cells
timeFrame: baseline
measure: Absolute Nucleated red blood cells
timeFrame: baseline
measure: Absolute Nucleated red blood cells
timeFrame: Week 4
measure: Platelet mean volume
timeFrame: baseline
measure: Platelet mean volume
timeFrame: Week 4
Locations:
city: Portland
country: United States
facility: Helfgott Research Institute
state: Oregon
Study officials:
References: