Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-05-10
2022-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Trial on Digestive Enzymes: Effects on Post-Meal Response to High-Macronutrient Meals
NCT06949735
The Effect of Whole Grain on Gut Microbiome and Metabolic Health
NCT01731366
Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes
NCT03449849
A Study to Evaluate Efficacy of Different Natural Ingredients in Improving Gut Health in Adults With Leaky Gut.
NCT05952232
Crossover Trials Which Assessed Consumption of Slowly Digestible Carbohydrates for 21 Days on Gastric Emptying Rates
NCT05430061
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
Subjects will be administered 3 daily doses (one per meal) of digestive enzymes (50mg), in a capsule, for 30 days
Digestive enzyme blend
Subjects will take 3 capsules (one per meal) of digestive enzymes (50mg) daily for 30 days.
Placebo
Subjects will be administered 3 daily doses (one per meal) of digestive enzymes (50mg), in a capsule, for 30 days
Placebo
Subjects will take 3 capsules (one per meal) of a placebo (50mg) daily for 30 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Digestive enzyme blend
Subjects will take 3 capsules (one per meal) of digestive enzymes (50mg) daily for 30 days.
Placebo
Subjects will take 3 capsules (one per meal) of a placebo (50mg) daily for 30 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kennesaw State University
OTHER
Deerland Enzymes
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Trisha VanDusseldorp, PhD
Role: PRINCIPAL_INVESTIGATOR
Kennesaw State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kennesaw State University
Kennesaw, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Digestive Enzymes
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.