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NCT07852481

Metabolic Effects of an Ophiocordyceps Sinensis- and CoQ10-Based Formulation in Mild-to-Moderate Hypercholesterolemia

Sponsor: noiVita Srls

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluation of the Metabolic Effects of a Formulation Based on Cordyceps Sinensis and Coenzyme Q10 in Subjects With Mild-moderate Hypercholesterolaemia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-10-19

Completion Date

2027-02-28

Last Updated

2026-10-08

Healthy Volunteers

Conditions

Hypercholesterolemia Lipid Metabolism Disorders Lipid Metabolism Nutraceutical Metabolic Disorder

Interventions

DIETARY_SUPPLEMENT

CORDICOL

CORDICOL 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.

OTHER

Placebo

The 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.

Inclusion Criteria: * 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. * Baseline LDL-C levels between 130 mg/dL and 190 mg/dL. * Signing of written informed consent. Exclusion Criteria: * 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. * Current use or use within the previous 3 months of hormonal therapies that may affect the hypothalamic-pituitary-gonadal axis, including testosterone, anabolic steroids, oral oestrogen-progestin therapies/contraceptives, or hydrocortisone. * Severe obesity (BMI ≥40 kg/m²). * Severe hepatic or renal impairment. * Current pregnancy or breastfeeding. Pregnancy status will be confirmed by a urinary β-hCG pregnancy test at the baseline visit (T0) in all women of childbearing potential, except postmenopausal women, defined as the absence of menstruation for at least 12 consecutive months since the last menstrual period. * Participation in another clinical trial within the previous 3 months. * Known hypersensitivity or allergy to the active ingredients (Ophiocordyceps sinensis or Coenzyme Q10) or to any excipient contained in the investigational product. * Inability to provide informed consent independently.