Digestive HealthMULONCT04917913
Efficacy of a Digestive Enzyme Blend
A study testing Digestive enzyme blend in people with Digestive Health and Indigestion, run by Deerland Enzymes at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of a digestive enzyme supplement (three times per day for 30 days) on gastrointestinal distress (GID) and body composition (body mass and body fat percentage) in healthy men and women (18 - 55 years of age) who experience regular GID (3 - 6 episodes of GID per… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Health, Indigestion, Protein Digestion
- What is being tested?
- Digestive enzyme blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 31 Jan 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be 18 - 55 years of age.
- Experience occasional gastrointestinal distress - 3 -6 episodes per month.
- Gastrointestinal distress may be defined as constipation, upset stomach, diarrhea, stomach cramping, bowel incontinence, heart-burn, acid reflux, gastroesophageal reflux, bloating or swelling of the belly, nausea or vomiting
Who cannot join
- Currently taking prescription medications for gastrointestinal distress.
- Taking prescription medications that may be impacted by enzyme consumption.
- Taking steroidal medications.
- Currently ill. Have a diagnosed severe gastrointestinal disorder including: fissures, abscesses, or hemorrhoids.
- Have a greater than 30 kg/m2 BMI.
- Currently pregnant or attempting to get pregnant.
- Do not have access to a cell phone or computer daily.
- Are being treated by a clinician for GI disease.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kennesaw State University
Kennesaw, Georgia, 30144
Trisha VanDusseldorp, PhD, 470-578-4266, tvanduss@kennesaw.edu
About this study
Official title: Efficacy of a Digestive Enzyme Blend: A Randomized, Double-Blind, Placebo-controlled Trial
The purpose of this study is to investigate the effect of a digestive enzyme supplement (three times per day for 30 days) on gastrointestinal distress (GID) and body composition (body mass and body fat percentage) in healthy men and women (18 - 55 years of age) who experience regular GID (3 - 6 episodes of GID per month).
Read the detailed description
Pre-Screening: Subjects will first undergo a pre-screening visit with the PI. The PI will go over the COVID-19 screening as well as the study screening for inclusion and exclusion criteria. Subjects will be given information regarding the study details, location of the study, and parking during this pre-screening visit as well.
Visit 1: This session will take place at the Exercise Physiology Laboratory (Prillaman 1102 - Kennesaw State University) and subjects will be asked to arrive fasted (8-10 hours). Subjects will be informed of the purpose, risks, and benefits of the study. They will be asked to review and sign this consent form. Subjects may ask questions at any time. They will then complete a Health History Questionnaire (HHQ) consisting of medical, physical activity, diet, and supplementation history. Following completion of this consent and the HHQ a member of the research team will take subjects to assess height, weight, and body composition (assessments described below). Immediately following the body composition assessment, they will be asked to fill out a series of questionnaires. These questionnaires will be electronic and will require subjects to use a computer as well as applications on their phone (surveys and applications described below).
A member of the research team will describe how to use the applications and computer programs: 1) Cronometer (for dietary tracking); 2) MyGiHealth (for GID tracking); and 3) SurveyMonkey (for GID tracking and supplement compliance tracking). Once subjects have completed all surveys a member of the research team will then distribute their first 30 day allotment of supplement (blinded, randomly assigned enzyme or placebo - both are 200 mg per pill) and provide subjects with instructions on how to take the supplement (3 times per day - right before a meal - for example right before breakfast, lunch, and dinner). They will then be informed on how to track their GID and diet throughout the 30 days of supplementation (described below). Lastly, subjects will be given their return date for Visit 2 and work with the research team member on a time that works for them.
Visit 2: Subjects will return to the lab for Visit 2 following 30 days of supplementation. During visit 2, they will have their body composition reassessed, as well as complete all GID surveys as they did during Visit 1. Further, a member of the research team will ensure that they completed all proper tracking of diet and GID during the 30 day supplementation period. Subjects will then work with the research team member to determine a Visit 3 date. Visit 3 will be at least 7 days after Visit 2.
Visit 3 and Visit 4: Visits 3 and 4 will be similar to Visits 1 and 2, respectively. However, subjects will not complete the informed consent form again and will not have to download/install the applications, as they will have completed this during Visit 1. During Visits 3 and 4, they will first have their body composition reassessed and fill out questionnaires (GID) (same as Visit 1 and 2). Further, subjects will be asked to take the supplement they did not receive during the first 30 days, for 30 days following Visit 3 (still blind to both the participants and research team). Subjects again will be asked to track their diet and GID during the 30 days of supplementation between Visits 3 and 4 (see tracking below). Following completion of Visit 4, subjects will receive their body composition results from visits 4.
- Conditions
- Digestive Health, Indigestion, Protein Digestion, Carbohydrate Digestion, Fat Digestion, Satiety
- Being tested
- Digestive enzyme blend, Placebo
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digestive enzyme blendDietary supplement
Subjects will take 3 capsules (one per meal) of digestive enzymes (50mg) daily for 30 days.
PlaceboDietary supplement
Subjects will take 3 capsules (one per meal) of a placebo (50mg) daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects will be administered 3 daily doses (one per meal) of digestive enzymes (50mg), in a capsule, for 30 days Receives: Dietary Supplement: Digestive enzyme blend |
| Placebo | Placebo comparator | Subjects will be administered 3 daily doses (one per meal) of digestive enzymes (50mg), in a capsule, for 30 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Distress
Analyze change in gastrointestinal distress symptoms obtained from questionnaires from baseline to 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start10 May 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive HealthStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deerland Enzymes
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kennesaw State University
- Responsible party
- Sponsor
- Investigators
- Trisha VanDusseldorp, PhD, Principal investigator, Kennesaw State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917913
- Sponsor's protocol ID
- Digestive Enzymes
- Acronym
- MULO
- Status last verified
- Jun 2021
- First submitted
- 26 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Digestive Enzyme Blend: A Randomized, Double-Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04917913
- Acronym / sponsor ID
- MULO / Digestive Enzymes
- Conditions
- Digestive Health, Indigestion, Protein Digestion, Carbohydrate Digestion, Fat Digestion, Satiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Deerland EnzymesIndustry (pharma, biotech, devices)
- Collaborators
- Kennesaw State University
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 8 Jun 2021 (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 investigate the effect of a digestive enzyme supplement (three times per day for 30 days) on gastrointestinal distress (GID) and body composition (body mass and body fat percentage) in healthy men and women (18 - 55 years of age) who experience regular GID (3 - 6 episodes of GID per month).
Detailed description
Pre-Screening: Subjects will first undergo a pre-screening visit with the PI. The PI will go over the COVID-19 screening as well as the study screening for inclusion and exclusion criteria. Subjects will be given information regarding the study details, location of the study, and parking during this pre-screening visit as well.
Visit 1: This session will take place at the Exercise Physiology Laboratory (Prillaman 1102 - Kennesaw State University) and subjects will be asked to arrive fasted (8-10 hours). Subjects will be informed of the purpose, risks, and benefits of the study. They will be asked to review and sign this consent form. Subjects may ask questions at any time. They will then complete a Health History Questionnaire (HHQ) consisting of medical, physical activity, diet, and supplementation history. Following completion of this consent and the HHQ a member of the research team will take subjects to assess height, weight, and body composition (assessments described below). Immediately following the body composition assessment, they will be asked to fill out a series of questionnaires. These questionnaires will be electronic and will require subjects to use a computer as well as applications on their phone (surveys and applications described below).
A member of the research team will describe how to use the applications and computer programs: 1) Cronometer (for dietary tracking); 2) MyGiHealth (for GID tracking); and 3) SurveyMonkey (for GID tracking and supplement compliance tracking). Once subjects have completed all surveys a member of the research team will then distribute their first 30 day allotment of supplement (blinded, randomly assigned enzyme or placebo - both are 200 mg per pill) and provide subjects with instructions on how to take the supplement (3 times per day - right before a meal - for example right before breakfast, lunch, and dinner). They will then be informed on how to track their GID and diet throughout the 30 days of supplementation (described below). Lastly, subjects will be given their return date for Visit 2 and work with the research team member on a time that works for them.
Visit 2: Subjects will return to the lab for Visit 2 following 30 days of supplementation. During visit 2, they will have their body composition reassessed, as well as complete all GID surveys as they did during Visit 1. Further, a member of the research team will ensure that they completed all proper tracking of diet and GID during the 30 day supplementation period. Subjects will then work with the research team member to determine a Visit 3 date. Visit 3 will be at least 7 days after Visit 2.
Visit 3 and Visit 4: Visits 3 and 4 will be similar to Visits 1 and 2, respectively. However, subjects will not complete the informed consent form again and will not have to download/install the applications, as they will have completed this during Visit 1. During Visits 3 and 4, they will first have their body composition reassessed and fill out questionnaires (GID) (same as Visit 1 and 2). Further, subjects will be asked to take the supplement they did not receive during the first 30 days, for 30 days following Visit 3 (still blind to both the participants and research team). Subjects again will be asked to track their diet and GID during the 30 days of supplementation between Visits 3 and 4 (see tracking below). Following completion of Visit 4, subjects will receive their body composition results from visits 4.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Digestive enzyme blendSubjects will be administered 3 daily doses (one per meal) of digestive enzymes (50mg), in a capsule, for 30 days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects will be administered 3 daily doses (one per meal) of digestive enzymes (50mg), in a capsule, for 30 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be 18 - 55 years of age.
- Experience occasional gastrointestinal distress - 3 -6 episodes per month.
- Gastrointestinal distress may be defined as constipation, upset stomach, diarrhea, stomach cramping, bowel incontinence, heart-burn, acid reflux, gastroesophageal reflux, bloating or swelling of the belly, nausea or vomiting
Key exclusion criteria (8 listed)
- Currently taking prescription medications for gastrointestinal distress.
- Taking prescription medications that may be impacted by enzyme consumption.
- Taking steroidal medications.
- Currently ill. Have a diagnosed severe gastrointestinal disorder including: fissures, abscesses, or hemorrhoids.
- Have a greater than 30 kg/m2 BMI.
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 |
|---|---|---|
| Digestive enzyme blendSubjects will take 3 capsules (one per meal) of digestive enzymes (50mg) daily for 30 days. | Dietary supplement | Intervention |
| PlaceboSubjects will take 3 capsules (one per meal) of a placebo (50mg) daily for 30 days. | Dietary supplement | Placebo |
Primary outcome
Gastrointestinal Distress
Time frame: 30 days
Analyze change in gastrointestinal distress symptoms obtained from questionnaires from baseline to 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Trisha VanDusseldorp, PhD principal investigator
Kennesaw State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digestive enzyme blend in people with Digestive Health and Indigestion, run by Deerland Enzymes 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 3 inclusion and 8 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 8 Jun 2021. 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 Michael M Lelko, MS (7707013094, mlelko@deerland.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Distress (time frame: 30 days). 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 8 Jun 2021.