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.
Age between 18 and 65 (men and women).
Plasma triglycerides ≥ 150 mg/dL.
HDL cholesterol < 40 mg/dL (men) or < 50 mg/dL (women).
Fasting blood glucose ≥ 100 mg/dL.
History of major cardiovascular events, including myocardial infarction, stroke, angina, or coronary revascularization.
Uncontrolled type 1 or type 2 diabetes mellitus, defined as HbA1c >8.0%.
Use of statins, ezetimibe, fibrates, or other lipid-lowering or metabolic supplements within 3 months prior to screening.
Overall cardiovascular risk profile for which lipid-lowering pharmacological treatment with statins is indicated according to current ESC/EAS Guidelines for the management of dyslipidaemias. Cardiovascular risk will be systematically assessed during screening using the recommended risk stratification tools (SCORE2 or SCORE2-OP, as applicable according to the participant's age), together with the overall clinical assessment. Candidates for whom statin therapy is clinically indicated according to these Guidelines will therefore be excluded.
Parallel
CORDICOL
Dietary supplementCORDICOL is a nutraceutical formulation containing 200 mg of Ophiocordyceps sinensis extract and 50 mg of Coenzyme Q10 per capsule. Participants will take one capsule orally once daily for the duration of the treatment period. The intervention is intended to evaluate the effects of the formulation on lipid and glucose metabolism in subjects with mild-to-moderate hypercholesterolemia.
Placebo
Other interventionThe placebo consists of capsules identical to the active CORDICOL capsules in appearance, size, color, taste, and packaging, but containing no active ingredients. Participants will take one capsule orally once daily for the duration of the treatment period. The placebo will be manufactured under GMP-compliant conditions and packaged in anonymized blisters identified by the unique participant code.
To evaluate the efficacy of CORDICOL compared to placebo in reducing LDL cholesterol levels (LDL-C)
The primary endpoint of the study is represented by the percentage change in levels of LDL cholesterol (LDL-C) from baseline (T0) to end of treatment (week 12). LDL cholesterol is the main modifiable lipid factor associated with risk cardiovascular and is universally recognized as a priority therapeutic target in primary cardiovascular prevention. The evaluation of its variation represents therefore the most appropriate parameter to determine the metabolic efficacy of the study formulation
To assess potential beneficial changes in lipid and hemorheological profiles compared with placebo, including: Total cholesterol (TC); HDL cholesterol (HDL-C) and Triglycerides (TG)
In addition to LDL cholesterol, the study will assess changes in total cholesterol, triglycerides, and HDL cholesterol, which plays an important role in reverse cholesterol transport and vascular protection.
To assess changes in glycemic homeostasis compared with placebo, including the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index
Fasting blood glucose and fasting insulin concentrations will be assessed and used to calculate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index. HOMA-IR is a continuous numerical index with a theoretical minimum value of 0 and no predefined maximum value. Higher HOMA-IR values indicate greater insulin resistance and therefore a worse outcome, whereas lower values indicate greater insulin sensitivity and therefore a better outcome. Changes in HOMA-IR from baseline will be evaluated to explore the possible impact of treatment on insulin sensitivity and carbohydrate homeostasis, which are closely related to alterations in lipid metabolism.
Evaluate an improvement in quality of life compared to the group Placebo.
The impact of treatment on quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L assesses health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five response levels for each dimension. Each dimension is scored from 1 (no problems) to 5 (extreme problems), with higher dimension scores indicating worse health status. The responses will be converted into a single EQ-5D-5L Index Value using the applicable country-specific value set. The Index Value ranges from values below 0 to 1, with 1 representing the best possible health state (perfect health); therefore, higher Index Values indicate better health-related quality of life, with values closer to 1 representing better health status. The joint use of this tool will allow biochemical outcomes to be integrated with the patient's subjective perception of health status and clinical benefit.
Evaluate the perceived benefit compared to the Placebo group.
The benefit perceived by the participant will be assessed using a 7-point Likert-type Global Perceived Effect (GPE) scale designed to capture the participant's subjective perception of change following treatment. Each participant will report how their condition has changed compared with the pre-treatment phase by selecting one of seven possible responses: 1 = definitely worsened, 2 = worsened, 3 = did not improve, 4 = no change, 5 = partly improved, 6 = improved, and 7 = definitely improved. Higher scores indicate a greater perceived benefit and improvement in the participant's health status, whereas lower scores indicate a worse perceived outcome. The joint use of this tool will allow biochemical outcomes to be integrated with the participant's subjective perception of health status and clinical benefit.
Click on the lead sponsor to view all of their trials.
noiVita Srls
Lead sponsor
Ospedale Beauregard, AUSL, Valle d'Aosta
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
