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Lipase Supplements for Digestive Health

JR
SR
Overseen ByStephanie Recker
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Danisco

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to investigate the effect of two digestive enzyme dietary supplements, THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases in supporting the breakdown of fat after a meal. The first dietary supplement, THRIVE4U™ TG Lipase, contains a single lipase while the other, THRIVE4U™ Spectrum Lipases, contains a blend of lipases. Lipase breaks down fats to allow your body to efficiently absorb it from food. Poor digestion of fat can cause gastrointestinal symptoms and can impact quality of life. By improving the digestion of fats from high-fat foods, the lipase(s) may help reduce discomfort and support overall digestive health.

Who Is on the Research Team?

ZJ

Zamir J Latif, PharmD

Principal Investigator

International Flavors and Fragrances

Are You a Good Fit for This Trial?

This trial is for generally healthy adults who may have mild digestive issues or trouble absorbing fats. People with serious health conditions, allergies to the supplements, or other reasons that could affect study results cannot participate.

Inclusion Criteria

Agree to use acceptable contraceptive methods and have negative pregnancy tests if of childbearing potential from screening until 30 or 90 days after study product administration
Able to consume all aspects of the O3-SACT
FE-1 levels between 100 - 300 μg/g within 12 months of screening
See 16 more

Exclusion Criteria

Lifestyle incompatible with trial such as extreme diets, intense physical activity >10 hours/week, or other factors as determined by investigator
Individuals of childbearing potential who are pregnant, intending to breastfeed, or intending to conceive at consent or during study or have positive pregnancy test
Known sensitivity, intolerability, or allergy to study products, excipients, or components
See 17 more

What Are the Treatments Tested in This Trial?

Interventions

  • THRIVE4U™ Spectrum Lipases
  • THRIVE4U™ TG Lipase

Trial Overview

The study tests two dietary enzyme supplements—one with a single lipase (THRIVE4U™ TG Lipase) and one with a blend of lipases (THRIVE4U™ Spectrum Lipases)—against a placebo to see if they help break down and absorb fat after eating.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: THRIVE4U™ TG Lipase (TP1)Experimental Treatment1 Intervention
Group II: THRIVE4U™ Spectrum Lipases (TP2)Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Danisco

Lead Sponsor

Trials
35
Recruited
3,600+

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials
40
Recruited
2,400+

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