A Study of Single and Combination Lipase Dietary Supplements to Increase Fatty Acid Absorption in Generally Health Adults

NCT07893288 | Not Yet Recruiting Phase 1

• 1 other identifier: I02-25-01-T0095
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Digestive Symptoms; Gastrointestinal Symptoms; Healthy; Impaired Pancreatic Function

Keywords

THRIVE4U™; THRIVE4U; Lipase; Fatty Acid Absorption; Exocrine Pancreatic Dysfunction

Outcome Measures

Primary Outcomes (6)

• To evaluate the dose-response effect of THRIVE4U™ TG Lipase (TP1) and THRIVE4U™ Spectrum Lipases (TP2) on increasing fatty acid absorption across ascending dose levels within each TP group after a single dose

  Plasma concentrations EPA as assessed by the O3-SACT

  Day 1 of each dose level within each TP group and controlled by baseline challenge

• To evaluate the dose-response effect of TP1 and TP2 on increasing fatty acid absorption across ascending dose levels within each TP group after a single dose

  Plasma concentrations DHA as assessed by the O3-SACT

  Day 1 of each dose level within each TP group and controlled by baseline challenge

• To evaluate the dose-response effect of TP1 and TP2 on increasing fatty acid absorption across ascending dose levels within each TP group after a single dose

  Plasma concentrations total fatty acid profile as assessed by the O3-SACT

  Day 1 of each dose level within each TP group and controlled by baseline challenge

• To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose

  Plasma concentrations of EPA as assessed by the O3-SACT

  Day 1 of each dose level between TP and placebo and controlled by baseline challenge

• To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose

  Plasma concentrations of DHA as assessed by the O3-SACT

  Day 1 of each dose level between TP and placebo and controlled by baseline challenge

• To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose

  Plasma concentrations of the total fatty acid profile as assessed by the O3-SACT

  Day 1 of each dose level between TP and placebo and controlled by baseline challenge

Secondary Outcomes (14)

• To evaluate the effects of TP1 and TP2 on heartburn across ascending dose levels within each TP group and at different dose levels compared to placebo after 7 days of supplementation

  Heartburn severity will be assessed at baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)

• To evaluate the effects of TP1 and TP2 on digestive discomfort within each TP group and at different dose levels compared to placebo after 7 days of supplementation

  GSRS subscale scores will be assessed at baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)

• To evaluate the effects of TP1 and TP2 on quality of life within each TP group and at different dose levels compared to placebo after 7 days of supplementation

  PROMIS - Global Health scores will be assessed at baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)

• To evaluate the effects of overall exposure to TP1 and TP2 on quality of life over the study period compared to placebo

  RAND-36 score will be assessed during the pre-dose period (Day -1) and Day 22

• To evaluate the effects of TP1 and TP2 on the absorption of fat-soluble vitamins D, A, E, and K within each TP group and at different dose levels compared to placebo after 7 days of supplementation

  Blood draw will occur during baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)

Other Outcomes (12)

• To explore changes in individual GSRS items following treatment with TP or placebo

  Up to end of study (Day 22) or early termination visit

• To assess the safety of TP1 and TP2 (Vitals)

  Up to end of study (Day 22) or early termination visit

• To assess the safety of TP1 and TP2 (Vitals)

  Up to end of study (Day 22) or early termination visit

Study Arms (3)

THRIVE4U™ TG Lipase (TP1)

EXPERIMENTAL

Study product dosing sequences: Dose Level 1(Low) → Dose Level 2 (Medium) → Dose Level 3 (High)

Dietary Supplement: THRIVE4U™ TG Lipase

THRIVE4U™ Spectrum Lipases (TP2)

EXPERIMENTAL

Study product dosing sequences: Dose Level 1(Low) → Dose Level 2 (Medium) → Dose Level 3 (High)

Dietary Supplement: THRIVE4U™ Spectrum Lipases

Placebo

PLACEBO COMPARATOR

Same dose throughout

Dietary Supplement: Placebo

Interventions

THRIVE4U™ TG Lipase DIETARY_SUPPLEMENT

THRIVE4U™ TG Lipase is a microbial-derived lipase enzyme supplement administered orally with meals. Participants receive ascending dose levels of low, medium, and high of lipase activity over a 3-week supplementation period (1 week of supplementation for each dose).

THRIVE4U™ TG Lipase (TP1)

THRIVE4U™ Spectrum Lipases DIETARY_SUPPLEMENT

THRIVE4U™ Spectrum Lipases is a microbial-derived lipase blend administered orally with meals. Participants receive ascending dose levels of low, medium, and high of lipase activity over a 3-week supplementation period (1 week of supplementation for each dose).

THRIVE4U™ Spectrum Lipases (TP2)

Placebo DIETARY_SUPPLEMENT

Matching placebo capsules administered orally with meals. Placebo capsules are identical in appearance to the active study products but contain no active lipase enzyme.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults who are between 18 - 65 years of age (inclusive) at the time of signing the informed consent.
• Have a BMI range of 18.0 - 29.9 kg/m2 (inclusive)
• Weigh no less than 50 kilograms.
• Are able to consume all aspects of the O3-SACT.
• Are able to consume all standardized in-clinic meals provided.
• Are able to consume the assigned study product and study components.
• Regularly consumes 3 meals a day.
• Have FE-1 levels that are between 100 - 300 μg/g within 12 months of screening.
• Have a presence of gastrointestinal (GI) symptoms as confirmed by a GSRS total score between 2 and 5 (inclusive) at screening.
• Have hematological, serum, and urine parameters within normal limits or not clinically significant, as determined by the investigator.
• Must have suitable veins for repeated venipuncture.
• Non-smokers (including nicotine vaping) and have not used any nicotine products (patches, gums, etc.) for \> 3 months prior to Visit 2. Non-smoker is defined as someone who does not habitually/regularly use products containing nicotine and willing to abstain for 14 days before Visit 2 until the last procedure.
• Agree to fast overnight, i.e., no food or liquids (except for water, permitted up to 15 min prior to dosing) for a minimum of 12 h prior to each post-screening visit.
• In otherwise good general health, as deemed by the investigator (based on a review of medical history, vital signs, laboratory safety tests, and physical examination if performed at screening).
• Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study (unless required per the restrictions).

You may not qualify if:

• Individuals of CBP who are pregnant, intending to breastfeed, or intending to conceive at the time of consent and during the study, or demonstrate a positive pregnancy test.
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients or any of the study components.
• Have participant reported Type I diabetes, Type II diabetes, high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or thyroid disease.
• Have participant reported current diagnosis of a disease causing chronic or recurrent muscle breakdown (e.g., inflammatory myositis, muscular dystrophy, dermatomyositis)
• Have had recent major muscle-related injury within the past 4 weeks prior to screening (e.g., bone fracture, crush injury, deep soft-tissue injury).
• Have current symptoms, or symptoms within the past 7 days, of an acute infection (e.g., fever, respiratory symptoms such as persistent cough or difficulty breathing), that may influence study outcomes as assessed by the investigator.
• Have participant reported history or current diagnosis of cystic fibrosis.
• Have clinically significant abnormal laboratory values at screening, including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 5× ULN, alkaline phosphatase \> 2× ULN, estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73 m², urine protein ≥ 30 mg/dL, or International Normalized Ratio (INR) ≥ 1.2.
• Have participant reported history of prior gastrointestinal surgery (e.g., gastric bypass, gastrectomy, gastric banding, or other visceral surgery) that may interfere with normal gastrointestinal anatomy or function or confound study results.
• Have participant reported history or current diagnosis of eating disorders such as anorexia or bulimia.
• Have participant reported history of or current use of any prescribed or non-prescribed medication that could potentially interfere with gastric pH, intestinal motility, or fat absorption, including herbal and dietary supplements and antacids. These medications will be discontinued for a minimum of five times their half-life prior to study product administration.
• Have a lifestyle incompatible with the trial, such as adherence to extreme diets (e.g., hypocaloric, ketogenic), participation in intense physical activity exceeding 10 hours per week, or any other lifestyle factors as determined by the investigator.
• Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel syndrome, ulcerative colitis, irritable bowel syndrome \[mixed, constipation-predominant, diarrhea-predominant\], or celiac disease).
• Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
• Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.

Sponsors & Collaborators

• Danisco: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Apex Trials

Guelph, Ontario - on, N1G 0B4, Canada

Location

Study Officials

• Zamir J Latif, PharmD

  International Flavors and Fragrances

  STUDY DIRECTOR

Central Study Contacts

Jevaneeh Rubio

CONTACT

519-341-3367; jrubio@nutrasource.ca

Stephanie Recker

CONTACT

519-341-3367 Ext. 109; srecker@nutrasource.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)