Efficacy of a Digestive Enzyme Blend

NCT04917913 | Unknown

• 1 other identifier: Digestive Enzymes
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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; Satiety

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Distress

  Analyze change in gastrointestinal distress symptoms obtained from questionnaires from baseline to 30 days.

  30 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Subjects will be administered 3 daily doses (one per meal) of digestive enzymes (50mg), in a capsule, for 30 days

Dietary Supplement: Placebo

Interventions

Digestive enzyme blend DIETARY_SUPPLEMENT

Subjects will take 3 capsules (one per meal) of digestive enzymes (50mg) daily for 30 days.

Intervention

Placebo DIETARY_SUPPLEMENT

Subjects will take 3 capsules (one per meal) of a placebo (50mg) daily for 30 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deerland Enzymes: lead
• Kennesaw State University: collaborator

Study Sites (1)

Kennesaw State University

Kennesaw, Georgia, 30144, United States

RECRUITING

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Trisha VanDusseldorp, PhD

  Kennesaw State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael M Lelko, MS

CONTACT

7707013094; mlelko@deerland.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 8, 2021
• Study Start: May 10, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)