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

October 5, 2026 updated by: noiVita Srls

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • The study will begin with a 2-week run-in period (Week -2 to T0), during which participants will maintain their usual dietary and lifestyle habits. This period is intended to allow assessment of the lipid profile before baseline measurements and to identify relevant changes that may occur prior to initiation of the study treatment.
  • At baseline (T0), participants meeting all eligibility requirements will undergo clinical and laboratory assessments, including evaluation of lipid and metabolic parameters. The overall cardiovascular risk profile will also be assessed according to applicable clinical guidelines. Eligible participants will then be centrally randomized in a 1:1 ratio to receive either CORDICOL or a matching placebo (one capsule per day). Treatment allocation will remain blinded throughout the study.
  • During the 12-week intervention period, participants will take one capsule once daily. An intermediate assessment will be performed at Week 4 (T1) to monitor safety, treatment compliance, adverse events, and any relevant changes in clinical or lifestyle conditions. Blood samples will also be collected to assess the parameters under investigation, together with selected patient-reported outcomes, according to the study schedule.
  • At Week 12 (T2), participants will undergo the final on-site assessment. Laboratory evaluations will be performed to assess changes in lipid and glycemic homeostasis, including the primary lipid outcome and relevant secondary metabolic parameters. Safety and tolerability will also be evaluated, together with treatment compliance and patient-reported outcomes, including quality of life.
  • 30 days after treatment completion (T3), participants will be contacted remotely for follow-up. No additional on-site laboratory assessments are planned at this stage. The follow-up will focus on quality of life, perceived well-being, treatment-related concerns, and the identification of any adverse events occurring after treatment discontinuation.

Throughout the study, dietary habits and lifestyle factors will be monitored to identify clinically relevant changes that could influence the interpretation of the study outcomes. Safety will be assessed through systematic monitoring and documentation of adverse events, including their severity, duration, and potential relationship to the study intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A (CORDICOL)

Participants will receive CORDICOL, a nutraceutical formulation containing Ophiocordyceps sinensis (200 mg) and Coenzyme Q10 (50 mg), administered as one capsule per day. The product will be provided free of charge by the Sponsor, noiVita S.r.l.s., exclusively for use in the study, ensuring standardized dosing and continuity of treatment throughout the study period.
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 Names:
  • Ophiocordyceps sinensis + Coenzyme Q10
Placebo Comparator: Arm B - Placebo

Participants assigned to the placebo group will receive capsules identical in appearance, size, color, taste, and packaging to the active product, but containing no active ingredients. The placebo will be manufactured by a GMP-certified company and packaged in anonymized blisters identified only by the unique patient code assigned by the centralized system, ensuring treatment blinding throughout the study.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of CORDICOL compared to placebo in reducing LDL cholesterol levels (LDL-C)
Time Frame: - T-1 (Run-in phase = Week -2 to T0: assessment of lipid profile changes prior to baseline measurements) - T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days)

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
- T-1 (Run-in phase = Week -2 to T0: assessment of lipid profile changes prior to baseline measurements) - T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess potential beneficial changes in lipid and hemorheological profiles compared with placebo, including: Total cholesterol (TC); HDL cholesterol (HDL-C) and Triglycerides (TG)
Time Frame: - T-1 (Run-in phase = Week -2 to T0: assessment of lipid profile changes prior to baseline measurements) - T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days)

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.
- T-1 (Run-in phase = Week -2 to T0: assessment of lipid profile changes prior to baseline measurements) - T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days)
To assess changes in glycemic homeostasis compared with placebo, including the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index
Time Frame: - T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days)

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.
- T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days)
Evaluate an improvement in quality of life compared to the group Placebo.
Time Frame: - T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days) - T3: Week 16 (Day 30 after T2 - Remote Follow-up)

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.
- T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days) - T3: Week 16 (Day 30 after T2 - Remote Follow-up)
Evaluate the perceived benefit compared to the Placebo group.
Time Frame: - T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days) - T3: Week 16 (Day 30 after T2 - Remote Follow-up)

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.
- T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days) - T3: Week 16 (Day 30 after T2 - Remote Follow-up)
Evaluate the safety of treatment by adverse effects (AEs)
Time Frame: - T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days) - T3: Week 16 (Day 30 after T2 - Remote Follow-up)

The safety and tolerability of the study treatment will be evaluated throughout the study by systematically monitoring, recording, and assessing all adverse events (AEs; such as nausea, instetinal disorders, headache...) reported by participants or identified by the investigator. The occurrence, severity, duration, and potential relationship to the study treatment will be documented and evaluated in accordance with applicable clinical study procedures and regulatory requirements.
- T0: Baseline - recruitment and randomization visit after the Run-in phase - T1: Week 4 (after 28 days) - T2: Week 12 (after 84 days) - T3: Week 16 (Day 30 after T2 - Remote Follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
noiVita Srls

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ospedale Beauregard, AUSL, Valle d'Aosta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 84958

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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