Trial · NCT07893288
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| 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. |
| Secondary | 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) | Change in serum vitamin D25 levels |
| Secondary | 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) | Change in serum vitamin A levels |
| Secondary | 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) | Change in serum vitamin E levels |
| Secondary | 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) | Change in serum vitamin K1 levels |
| Secondary | 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 | Blood draw will occur during pre-dose period (Day -1), baseline (Day 1), Day 8 and 15 | Postprandial serum vitamin D3 levels over 8 hours |
| Secondary | 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 draw will occur during baseline (Day 1), Day 8, 15, and 22 | Blood lipid levels (total cholesterol) |
| Secondary | 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 draw will occur during baseline (Day 1), Day 8, 15, and 22 | Blood lipid levels (HDL-C) |
| Secondary | 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 draw will occur during baseline (Day 1), Day 8, 15, and 22 | Blood lipid levels (LDL-C) |
| Secondary | 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 draw will occur during baseline (Day 1), Day 8, 15, and 22 | Blood lipid levels (TGs) |
| Secondary | 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 | Blood draw will occur during baseline (Day 1), Day 8, 15, and 22 | Up or down regulation of the signal intensity of lipid species within the plasma lipidomic profile |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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