Recruiting

Digestive Enzyme Blend

Sponsor:

Deerland Enzymes

Code:

NCT04917913

Conditions

Digestive Health

Indigestion

Protein Digestion

Carbohydrate Digestion

Fat Digestion

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Digestive enzyme blend

Placebo

Study Details

Brief 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 month).

Conditions

Digestive Health

Indigestion

Protein Digestion

Carbohydrate Digestion

Fat Digestion

Study ID

NCT04917913

Start date

May 10, 2021

Status verified date

Jun, 2021

Completion date

Jan 31, 2022

Anticipated

Primary completion date

Jan 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Intervention

Subjects will be administered 3 daily doses (one per meal) of digestive enzymes (50mg), in a capsule, 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

Interventions

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.

Primary outcome measure

  • Gastrointestinal Distress [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Michael M Lelko, MS

7707013094mlelko@deerland.com

Locations

Kennesaw State University

Recruiting

Kennesaw, Georgia, United States, 30144

Contacts

Trisha VanDusseldorp, PhD

470-578-4266tvanduss@kennesaw.edu

More Information

Sponsor

Deerland Enzymes

Last update posted

Jun 8, 2021

Last verified

Jun, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Deerland Enzymes on 2021-06-08.