Metabolic Effects of an Ophiocordyceps Sinensis- and CoQ10-Based Formulation in 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
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
- 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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Livio Leo Dott.
- Numer telefonu: 0165548275
- E-mail: lleo@ausl.vda.it
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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. |
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.
Inne nazwy:
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Komparator placebo: 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. |
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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To evaluate the efficacy of CORDICOL compared to placebo in reducing LDL cholesterol levels (LDL-C)
Ramy czasowe: - 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
To assess potential beneficial changes in lipid and hemorheological profiles compared with placebo, including: Total cholesterol (TC); HDL cholesterol (HDL-C) and Triglycerides (TG)
Ramy czasowe: - 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
Ramy czasowe: - 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)
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Evaluate an improvement in quality of life compared to the group Placebo.
Ramy czasowe: - 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)
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Evaluate the perceived benefit compared to the Placebo group.
Ramy czasowe: - 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)
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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)
Ramy czasowe: - 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)
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Współpracownicy i badacze
Sponsor
Współpracownicy
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 84958
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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