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NCT06243484: HEARTII
Effect of the Food Supplement TOTUM-070 on Lipid Metabolism
NA trial testing TOTUM-070 in Hypercholesterolemia in 180 participants. Participants enrolled and being followed up; not accepting new ones.
31 January 2025
Quick facts
| Lead sponsor | Valbiotis |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 180 |
| Start date | 4 October 2023 |
| Primary completion | 31 January 2025 |
| Estimated completion | 30 April 2025 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- TOTUM-070
- PLACEBO
Conditions studied
- Hypercholesterolemia — all drugs for Hypercholesterolemia →
Sponsor
Valbiotis
Who can join
Adults 18 to 70, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial is to confirm the effects of TOTUM-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood LDL cholesterol concentrations in moderately hypercholesterolemic subjects after 12 weeks of consumption (V3).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06243484
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TOTUM-070
Trials testing the same drug.
- NCT05594979 — Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic · NA · terminated
- NCT04760951 — Effect of Totum-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects · NA · completed
Other recruiting trials for Hypercholesterolemia
Currently open trials in the same condition.
- NCT07406191 — WB-EMS Effects on Cardiometabolic Risk Factors · NA · recruiting
- NCT07374861 — Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy · recruiting
- NCT07295327 — Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia · NA · recruiting
- NCT06568601 — Pharmacogenomic Informed Statin Prescribing · NA · recruiting
- NCT06423365 — A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication. · NA · active not recruiting
Other Valbiotis trials
Trials by the same sponsor.
- NCT06047847 — Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption · NA · completed
- NCT05594979 — Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic · NA · terminated
- NCT05469503 — Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure · NA · active not recruiting
- NCT05369585 — Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk · NA · completed
- NCT04760951 — Effect of Totum-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06243484 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Valbiotis
- Last refreshed: 1 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06243484.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing