DyspepsiaNCT06320379
Zypan Functional Dyspepsia
A study testing Zypan in people with Dyspepsia, run by National University of Natural Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Zypan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● 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)
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- 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
Who cannot join
- ● 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Helfgott Research Institute
Portland, Oregon, 97201
Anders Gundersen, MS
About this study
Official title: 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.
- Conditions
- Dyspepsia
- Being tested
- Zypan, Placebo Comparator
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZypanDietary 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
Placebo ComparatorDietary 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%)
| Study group | Role | What they receive |
|---|---|---|
| Zypan | Experimental | Not described Receives: Dietary Supplement: Zypan |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Assimilation
Concentrations of Amino Acids in Blood
Measured: Baseline
Protein Assimilation
Concentrations of Amino Acids in Blood
Measured: Week 4
Secondary outcomes (8)
Mineral concentrations in blood
Mineral concentrations in blood as measured by Genova Diagnostics NutrEval
Measured: Baseline
Mineral concentrations in blood
Mineral concentrations in blood as measured by Genova Diagnostics NutrEval
Measured: Week 4
Fat-soluble vitamin concentration in blood
Fat-soluble vitamin concentrations in blood as measured by Genova Diagnostics NutrEval
Measured: Baseline
Fat-soluble vitamins
Fat-soluble vitamin concentrations in blood as measured by Genova Diagnostics NutrEval
Measured: Week 4
Leeds Dyspepsia Questionnaire
Subjective measure of digestive symptoms
Measured: Baseline
Leeds Dyspepsia Questionnaire
Subjective measure of digestive symptoms
Measured: Week 4
Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale
Subjective measure of Quality of life related to physical function
Measured: Baseline
Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale
Subjective measure of Quality of life related to physical function
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start15 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to take either a placebo or Zypan dietary supplement three times per day for four weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Bradley, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320379
- Sponsor's protocol ID
- RB071522
- Status last verified
- Mar 2024
- First submitted
- 3 Apr 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Changes in Quality of Life and Digestion in Functional Dyspepsia in Adults
- ClinicalTrials.gov ID
- NCT06320379
- Acronym / sponsor ID
- RB071522
- Conditions
- Dyspepsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to take either a placebo or Zypan dietary supplement three times per day for four weeks.
| Arm | Type | Receives |
|---|---|---|
| Zypan | Experimental | Dietary Supplement: Zypan |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Comparator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ● Adults 18-70 years of age (inclusive)
Key exclusion criteria (15 listed)
- ● 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZypanThe 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 supplement | Zypan |
| Placebo ComparatorThe 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%) | Dietary supplement | Placebo |
Primary outcome
Protein Assimilation
Time frame: Baseline
Concentrations of Amino Acids in Blood
Protein Assimilation
Time frame: Week 4
Concentrations of Amino Acids in Blood
8 secondary outcomes
Mineral concentrations in blood
Time frame: Baseline
Mineral concentrations in blood
Time frame: Week 4
Fat-soluble vitamin concentration in blood
Time frame: Baseline
Fat-soluble vitamins
Time frame: Week 4
Leeds Dyspepsia Questionnaire
Time frame: Baseline
Leeds Dyspepsia Questionnaire
Time frame: Week 4
Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale
Time frame: Baseline
Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale
Time frame: Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zypan in people with Dyspepsia, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan Bradley, ND, MPH (503-502-1862, rbradley@nunm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein Assimilation (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.