No phaseNot yet recruiting
Evaluation of the Metabolic Effects of a Ophiocordyceps Sinensis- and Coenzyme Q10-Based Formulation in Subjects With Mild-to-Moderate Hypercholesterolemia (CORDICOL)
Evaluation of the Metabolic Effects of a Formulation Based on Cordyceps Sinensis and Coenzyme Q10 in Subjects With Mild-moderate Hypercholesterolaemia
- Sponsor
- noiVita Srls (Industry)
- Enrolment
- 140 planned
- Conditions
- Hypercholesterolemia; Lipid Metabolism Disorders; Lipid Metabolism; Nutraceutical; Metabolic Disorder
- Interventions
- CORDICOL; Placebo
- Ages
- adults, older adults
- Registry
- NCT07852481
From the registry
This randomized, double-blind, placebo-controlled study will evaluate the metabolic effects of CORDICOL, a formulation containing Ophiocordyceps sinensis extract (200 mg) and Coenzyme Q10 (50 mg), in adults with mild-to-moderate hypercholesterolemia. The study will compare CORDICOL with placebo, with LDL cholesterol as the primary outcome and additional assessments of lipid and glucose metabolism, safety, tolerability, and quality of life. The study will include a 2-week run-in period followed by a 12-week treatment period. Participants will undergo baseline assessment and randomization at T0, an intermediate safety and compliance assessment at Week 4 (T1), and a final assessment at Week 12 (T2). A remote follow-up will be conducted 30 days after treatment completion (T3) to assess quality of life and any late adverse events. The study will provide clinical information on the potential metabolic effects, safety, and tolerability of CORDICOL in subjects with mild-to-moderate hypercholesterolemia.
Primary outcomes
- To evaluate the efficacy of CORDICOL compared to placebo in reducing LDL cholesterol levels (LDL-C)