Food Supplement for Individuals With Polygenic Hypercholesterolaemia
NCT07918677, Not applicable, Recruiting, ESI
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Food Supplement for Individuals With Polygenic Hypercholesterolaemia | ClinicalTrials.gov |
| NCT number | NCT07918677 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | ESI | ClinicalTrials.gov |
| Conditions | Polygenic Hypercholesterolaemia | ClinicalTrials.gov |
| Interventions | Placebo, Combined Dietary Supplement (Normolip® colesterolo), Phytosterols | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in non-HDL cholesterol at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in non-HDL cholesterol from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing combined nutraceutical versus placebo. | ClinicalTrials.gov |
| Secondary | Change from baseline in total cholesterol at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in plasma total cholesterol from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms. | ClinicalTrials.gov |
| Secondary | Change from baseline in HDL-C at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in plasma HDL cholesterol (HDL-C) from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms. | ClinicalTrials.gov |
| Secondary | Change from baseline in triglycerides at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in plasma triglycerides from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms. | ClinicalTrials.gov |
| Secondary | Change from baseline in LDL-C at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in plasma LDL cholesterol (LDL-C) from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms. | ClinicalTrials.gov |
| Secondary | Change from baseline in remnant cholesterol at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in plasma remnant cholesterol from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms. | ClinicalTrials.gov |
| Secondary | Change from baseline in high-sensitivity C-reactive protein (hsCRP) at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in plasma hsCRP from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms. | ClinicalTrials.gov |
| Secondary | Change from baseline in Remnant Cholesterol Inflammatory Index (RCII) at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in RCII from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms. | ClinicalTrials.gov |
| Secondary | Change from baseline in Lipid Accumulation Product (LAP) at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in LAP from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms. | ClinicalTrials.gov |
| Secondary | Change from baseline in Hepatic Steatosis Index (HSI) at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in HSI from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms. | ClinicalTrials.gov |
| Secondary | Change from baseline in Fatty Liver Index (FLI) at 6 weeks (Day 42) | Baseline (T0) to 6 weeks (T1, Day 42) | Change in FLI from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms. | ClinicalTrials.gov |
| Other | Change in non-HDL cholesterol during open-label extension (Day 42 to Day 84) | Day 42 (T1) to Day 84 (T2) | Change in non-HDL cholesterol from end of double-blind phase (T1, Day 42) to end of open-label extension (T2, Day 84), when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses will be stratified by initial randomized group. | ClinicalTrials.gov |
| Other | Change in total cholesterol during open-label extension (Day 42 to Day 84) | Day 42 (T1) to Day 84 (T2) | Change in plasma total cholesterol from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group. | ClinicalTrials.gov |
| Other | Change in HDL-C during open-label extension (Day 42 to Day 84) | Day 42 (T1) to Day 84 (T2) | Change in plasma HDL-C from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group. | ClinicalTrials.gov |
| Other | Change in triglycerides during open-label extension (Day 42 to Day 84) | Day 42 (T1) to Day 84 (T2) | Change in plasma triglycerides from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group. | ClinicalTrials.gov |
| Other | Change in LDL-C during open-label extension (Day 42 to Day 84) | Day 42 (T1) to Day 84 (T2) | Change in plasma LDL-C from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group. | ClinicalTrials.gov |
| Other | Change in remnant cholesterol during open-label extension (Day 42 to Day 84) | Day 42 (T1) to Day 84 (T2) | Change in plasma remnant cholesterol from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group. | ClinicalTrials.gov |
| Other | Change in hsCRP during open-label extension (Day 42 to Day 84) | Day 42 (T1) to Day 84 (T2) | Change in plasma hsCRP from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group. | ClinicalTrials.gov |
| Other | Change in RCII during open-label extension (Day 42 to Day 84) | Day 42 (T1) to Day 84 (T2) | Change in Remnant Cholesterol Inflammatory Index (RCII) from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group. | ClinicalTrials.gov |
| Other | Change in LAP during open-label extension (Day 42 to Day 84) | Day 42 (T1) to Day 84 (T2) | Change in Lipid Accumulation Product (LAP) from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)