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NCT07852481Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
140 (estimated)
First submitted
25 Sept 2026
Start date
19 Oct 2026
Primary completion date
19 Feb 2027
Lead sponsor
noiVita Srls
NCT number
NCT07852481

What you commit to

  • Study type: Interventional
  • Planned participants: 140
  • From 19 Oct 2026 to the primary completion date, 19 Feb 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • History of major cardiovascular events, including myocardial infarction, stroke, angina, or coronary revascularization.
  • Severe hepatic or renal impairment.

Lab values

  • Uncontrolled type 1 or type 2 diabetes mellitus, defined as HbA1c \>8.0%.

Other

  • Severe obesity (BMI ≥40 kg/m²).
  • 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.
  • Inability to provide informed consent independently.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.