Trial · NCT07893288
A Study of Single and Combination Lipase Dietary Supplements to Increase Fatty Acid Absorption in Generally Health Adults
NCT07893288, Phase 1, Phase 2, Not yet recruiting, Danisco
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Single and Combination Lipase Dietary Supplements to Increase Fatty Acid Absorption in Generally Health Adults. Trials, record NCT07893288. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07893288
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Single and Combination Lipase Dietary Supplements to Increase Fatty Acid Absorption in Generally Health Adults
- NCT number
- NCT07893288
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Danisco
- Conditions
- Digestive Symptoms, Gastrointestinal Symptoms, Healthy, Impaired Pancreatic Function
- Interventions
- THRIVE4U™ TG Lipase, THRIVE4U™ Spectrum Lipases, Placebo
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Day 1 of each dose level within each TP group and controlled by baseline challenge | Plasma concentrations EPA as assessed by the O3-SACT |
| Primary | 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 | Day 1 of each dose level within each TP group and controlled by baseline challenge | Plasma concentrations DHA as assessed by the O3-SACT |
| Primary | 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 | 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 |
| Primary | To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose | 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 |
| Primary | To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose | 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 |
| Primary | To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose | 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 |
| Secondary | 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) | 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 |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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 | 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. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07893288
GET https://conductscience.org/api/trials/v1/NCT07893288/registered?page=2