Digestive SymptomsPhase 1/2NCT07893288
A Study of Single and Combination Lipase Dietary Supplements to Increase Fatty Acid Absorption in Generally Health Adults
A Phase 1/2 study testing THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases in people with Digestive Symptoms and Gastrointestinal Symptoms, run by Danisco at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Symptoms, Gastrointestinal Symptoms, Healthy
- What is being tested?
- THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2026to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- Agree, from screening until 30 days (for individuals of CBP) or 90 days (for individuals with the potential to impregnate others) after study product administration, to use acceptable contraceptive methods and have negative pregnancy tests if of CBP.
- Agree to follow the restrictions on concomitant treatments.
- Agree to follow the restrictions on lifestyle.
- Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Who cannot join
- 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.
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- 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.
- Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.) that may affect the participant's capability to carry out all procedures of the study at the investigator's discretion.
- Major surgery in 3 months prior to screening or planned major surgery during the study.
- Have a history of alcohol (more than 14 units per week) or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study.
- Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before Visit 2 or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
- Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Apex Trials
Guelph, Ontario - on, N1G 0B4
Ann Anton, 519-341-3366 ext. 120, aanton@apextrials.com
Mariya Chalaskanova, 519-546-5359, mchalashkanova@apextrials.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Three-Arm Study to Evaluate the Effects of 3-Week Supplementation With Single (THRIVE4U(TM) TG Lipase) and Combination Lipase (THRIVE4U(TM) Spectrum Lipases) Products on Increasing Fatty Acid Absorption in Generally Healthy Adults With Potential Exocrine Pancreatic Dysfunction
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.
Read the detailed description
This randomized, double-blind, placebo-controlled, dose-ranging Phase I/II clinical trial is designed to evaluate the effects of lipase enzyme formulations as dietary supplements, THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases, on fat digestion and absorption in generally healthy adults with evidence of reduced pancreatic enzyme activity. Participants will have fecal elastase-1 (FE-1) levels consistent with potential mild exocrine pancreatic dysfunction and mild-to-moderate gastrointestinal symptoms.
Dietary fats require digestion by lipase enzymes before they can be absorbed in the small intestine. Variability in digestive enzyme activity may reduce the efficiency of fat digestion in some individuals. The investigational products evaluated in this study are dietary supplements containing microbial lipase formulations intended to support the digestion of dietary fats. THRIVE4U™ TG Lipase contains a lipase enzyme formulation and THRIVE4U™ Spectrum Lipases contains a blend of lipase enzymes. The study will assess the effects of these products on markers of lipid digestion, absorption, and gastrointestinal health.
The study will enroll approximately 50 participants who will be randomized to receive THRIVE4U™ TG Lipase, THRIVE4U™ Spectrum Lipases, or placebo in a 2:2:1 allocation ratio. Participants assigned to either active dietary supplement will receive three ascending dose levels over a 3-week supplementation period, allowing assessment of dose-response effects.
To evaluate lipid digestion and absorption, the study will use a standardized Omega-3 Substrate Absorption Challenge Test (O3-SACT). This approach provides a controlled and reproducible method for assessing the impact of lipase supplementation.
In addition to assessing fatty acid absorption, the study will explore the effects of supplementation on several biological and patient-reported outcomes related to fat digestion. Blood samples will also be collected for lipidomic analyses to evaluate changes in circulating lipid species and provide additional insight into the metabolic effects of enhanced lipid digestion.
Safety and tolerability will be monitored throughout the study through clinical laboratory assessments, vital signs, adverse event reporting, and standardized gastrointestinal symptom assessments. Fecal samples and additional biological specimens may be collected and stored for future exploratory analyses of biomarkers related to digestion, metabolism, and gut health.
The study is intended to generate evidence regarding the efficacy, dose-response characteristics, and safety profile of two microbial lipase formulations. The goal is to assess the effects of THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases supplementation on markers of fat digestion and absorption, gastrointestinal symptoms, and related health outcomes in adults with potential exocrine pancreatic dysfunction. Results from this study may help inform the development of non-animal-derived digestive enzyme dietary supplements designed to support lipid digestion and nutrient absorption.
- Being tested
- THRIVE4U™ TG Lipase, THRIVE4U™ Spectrum Lipases, Placebo
- Keywords
- THRIVE4U™, THRIVE4U, Lipase, Fatty Acid Absorption, Exocrine Pancreatic Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE4U™ TG LipaseDietary 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™ Spectrum LipasesDietary 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).
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE4U™ TG Lipase (TP1) | Experimental | Study product dosing sequences: Dose Level 1(Low) → Dose Level 2 (Medium) → Dose Level 3 (High) Receives: 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) Receives: Dietary Supplement: THRIVE4U™ Spectrum Lipases |
| Placebo | Placebo comparator | Same dose throughout Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
The average severity of heartburn episodes, assessed by the Four-Graded Scale. Heartburn severity will be assessed using the mean score over the last 7 days.
- None = 0, no symptoms
- Mild = 1, awareness of symptoms, but easily tolerated
- Moderate = 2, discomfort sufficient to cause interference with normal activities
- Severe = 3, incapacitating, with inability to perform normal activities
Measured: 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
Gastrointestinal Symptom Rating Scale (GSRS) subscale scores for diarrhea, abdominal pain, indigestion, and constipation. Individual subscale items are rated using a 7-point Likert scale. Subscale scores are calculated by taking the average ratings of the applicable items:
- Diarrhea: items 11, 12 and 14
- Abdominal pain: items 1, 4 and 5
- Indigestion: items 6, 7, 8 and 9
- Constipation: items 10, 13 and 15 Higher subscales scores and individual item ratings indicate greater symptom severity.
Measured: 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 score is a 10-item self-report measure that produces two standardized T-scores, including Global Physical Health and Global Mental Health. Each score is derived from four items selected from the 10-item questionnaire. Scoring uses Item Response Theory. Raw summed scores can also be converted to T-scores using PROMIS lookup tables. The questionnaire is an overall evaluation of one's physical and mental health.
Measured: 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 is to evaluate the effects of the TPs at different dose levels on quality of life compared to placebo by assessing the change in the scale scores. A higher score indicates better health and well-being.
Measured: 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
Change in serum vitamin D25 levels
Measured: Blood draw will occur during 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 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
Change in serum vitamin A levels
Measured: Blood draw will occur during 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 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
Change in serum vitamin E levels
Measured: Blood draw will occur during 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 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
Change in serum vitamin K1 levels
Measured: Blood draw will occur during 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 the absorption of Vitamin D within each TP group and at different dose levels compared to placebo after a single dose
Postprandial serum vitamin D3 levels over 8 hours
Measured: Blood draw will occur during pre-dose period (Day -1), baseline (Day 1), Day 8 and 15
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Blood lipid levels (total cholesterol)
Measured: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Blood lipid levels (HDL-C)
Measured: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Blood lipid levels (LDL-C)
Measured: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Blood lipid levels (TGs)
Measured: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipidomic profiles within each TP group and at different dose levels compared to placebo after 7 days of supplementation by assessing the up or down regulation of the signal of lipid species within the plasma
Up or down regulation of the signal intensity of lipid species within the plasma lipidomic profile
Measured: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Zamir J Latif, PharmD, Study director, International Flavors and Fragrances
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893288
- Sponsor's protocol ID
- I02-25-01-T0095
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Three-Arm Study to Evaluate the Effects of 3-Week Supplementation With Single (THRIVE4U(TM) TG Lipase) and Combination Lipase (THRIVE4U(TM) Spectrum Lipases) Products on Increasing Fatty Acid Absorption in Generally Healthy Adults With Potential Exocrine Pancreatic Dysfunction
- ClinicalTrials.gov ID
- NCT07893288
- Acronym / sponsor ID
- I02-25-01-T0095
- Keywords
- THRIVE4U™, THRIVE4U, Lipase, Fatty Acid Absorption, Exocrine Pancreatic Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized, double-blind, placebo-controlled, dose-ranging Phase I/II clinical trial is designed to evaluate the effects of lipase enzyme formulations as dietary supplements, THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases, on fat digestion and absorption in generally healthy adults with evidence of reduced pancreatic enzyme activity. Participants will have fecal elastase-1 (FE-1) levels consistent with potential mild exocrine pancreatic dysfunction and mild-to-moderate gastrointestinal symptoms.
Dietary fats require digestion by lipase enzymes before they can be absorbed in the small intestine. Variability in digestive enzyme activity may reduce the efficiency of fat digestion in some individuals. The investigational products evaluated in this study are dietary supplements containing microbial lipase formulations intended to support the digestion of dietary fats. THRIVE4U™ TG Lipase contains a lipase enzyme formulation and THRIVE4U™ Spectrum Lipases contains a blend of lipase enzymes. The study will assess the effects of these products on markers of lipid digestion, absorption, and gastrointestinal health.
The study will enroll approximately 50 participants who will be randomized to receive THRIVE4U™ TG Lipase, THRIVE4U™ Spectrum Lipases, or placebo in a 2:2:1 allocation ratio. Participants assigned to either active dietary supplement will receive three ascending dose levels over a 3-week supplementation period, allowing assessment of dose-response effects.
To evaluate lipid digestion and absorption, the study will use a standardized Omega-3 Substrate Absorption Challenge Test (O3-SACT). This approach provides a controlled and reproducible method for assessing the impact of lipase supplementation.
In addition to assessing fatty acid absorption, the study will explore the effects of supplementation on several biological and patient-reported outcomes related to fat digestion. Blood samples will also be collected for lipidomic analyses to evaluate changes in circulating lipid species and provide additional insight into the metabolic effects of enhanced lipid digestion.
Safety and tolerability will be monitored throughout the study through clinical laboratory assessments, vital signs, adverse event reporting, and standardized gastrointestinal symptom assessments. Fecal samples and additional biological specimens may be collected and stored for future exploratory analyses of biomarkers related to digestion, metabolism, and gut health.
The study is intended to generate evidence regarding the efficacy, dose-response characteristics, and safety profile of two microbial lipase formulations. The goal is to assess the effects of THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases supplementation on markers of fat digestion and absorption, gastrointestinal symptoms, and related health outcomes in adults with potential exocrine pancreatic dysfunction. Results from this study may help inform the development of non-animal-derived digestive enzyme dietary supplements designed to support lipid digestion and nutrient absorption.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THRIVE4U™ TG Lipase (TP1) | Experimental | Dietary Supplement: THRIVE4U™ TG LipaseStudy product dosing sequences: Dose Level 1(Low) → Dose Level 2 (Medium) → Dose Level 3 (High) |
| THRIVE4U™ Spectrum Lipases (TP2) | Experimental | Dietary Supplement: THRIVE4U™ Spectrum LipasesStudy product dosing sequences: Dose Level 1(Low) → Dose Level 2 (Medium) → Dose Level 3 (High) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSame dose throughout |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRIVE4U™ TG LipaseTHRIVE4U™ 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). | Dietary supplement | THRIVE4U™ TG Lipase (TP1) |
| THRIVE4U™ Spectrum LipasesTHRIVE4U™ 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). | Dietary supplement | THRIVE4U™ Spectrum Lipases (TP2) |
| PlaceboMatching placebo capsules administered orally with meals. Placebo capsules are identical in appearance to the active study products but contain no active lipase enzyme. | Dietary supplement | Placebo |
Primary outcome
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
Time frame: Day 1 of each dose level within each TP group and controlled by baseline challenge
Plasma concentrations EPA as assessed by the O3-SACT
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
Time frame: Day 1 of each dose level within each TP group and controlled by baseline challenge
Plasma concentrations DHA as assessed by the O3-SACT
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
Time frame: Day 1 of each dose level within each TP group and controlled by baseline challenge
Plasma concentrations total fatty acid profile as assessed by the O3-SACT
To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose
Time frame: Day 1 of each dose level between TP and placebo and controlled by baseline challenge
Plasma concentrations of EPA as assessed by the O3-SACT
To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose
Time frame: Day 1 of each dose level between TP and placebo and controlled by baseline challenge
Plasma concentrations of DHA as assessed by the O3-SACT
To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose
Time frame: Day 1 of each dose level between TP and placebo and controlled by baseline challenge
Plasma concentrations of the total fatty acid profile as assessed by the O3-SACT
14 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Blood draw will occur during 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 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
Time frame: Blood draw will occur during 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 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
Time frame: Blood draw will occur during 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 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
Time frame: Blood draw will occur during 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 the absorption of Vitamin D within each TP group and at different dose levels compared to placebo after a single dose
Time frame: Blood draw will occur during pre-dose period (Day -1), baseline (Day 1), Day 8 and 15
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Time frame: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Time frame: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Time frame: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Time frame: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipidomic profiles within each TP group and at different dose levels compared to placebo after 7 days of supplementation by assessing the up or down regulation of the signal of lipid species within the plasma
Time frame: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zamir J Latif, PharmD study director
International Flavors and Fragrances
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases in people with Digestive Symptoms and Gastrointestinal Symptoms, run by Danisco at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jevaneeh Rubio (519-341-3367, jrubio@nutrasource.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 1 of each dose level within each TP group and controlled by baseline challenge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.