Efficacy of a Digestive Enzyme Blend (MULO)

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).

Study Overview

• Status: Recruiting
• Conditions: Satiety; Indigestion; Digestive Health; Protein Digestion; Carbohydrate Digestion; Fat Digestion
• Intervention / Treatment: Dietary supplement: Digestive enzyme blend; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael M Lelko, MS; Phone Number: 7707013094; Email: mlelko@deerland.com

Study Locations

• United States
  • Georgia
    • Kennesaw, Georgia, United States, 30144
      • Recruiting
      • Kennesaw State University
      • Contact: Trisha VanDusseldorp, PhD; Phone Number: 470-578-4266; Email: tvanduss@kennesaw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Subjects will be administered 3 daily doses (one per meal) of digestive enzymes (50mg), in a capsule, for 30 days	Dietary supplement: Digestive enzyme blend; Subjects will take 3 capsules (one per meal) of digestive enzymes (50mg) daily for 30 days.
Placebo Comparator: Placebo; Subjects will be administered 3 daily doses (one per meal) of digestive enzymes (50mg), in a capsule, for 30 days	Dietary supplement: Placebo; Subjects will take 3 capsules (one per meal) of a placebo (50mg) daily for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Distress	Analyze change in gastrointestinal distress symptoms obtained from questionnaires from baseline to 30 days.	30 days

Collaborators and Investigators

• Sponsor: Deerland Enzymes
• Collaborators: Kennesaw State University
• Investigators: Principal Investigator: Trisha VanDusseldorp, PhD, Kennesaw State University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: Digestive Enzymes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No