Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-70
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

The primary outcome is to evaluate the effect of Cynacol on the change in LDL-C levels compared to Metacol after 90 days of supplementation.

The secondary outcomes are to evaluate:

\- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age between 35-70 years

both genders

LDL-C levels between 115 and 190 mg/dl

subjects able to understand the informed consent and sign it before enrollment in the study

Disqualifiers

personal history of cardiovascular disease or equivalent risk factors

Tg levels ≥ 400 mg/dl

obesity [body mass index (BMI) ≥ 30 kg/m²]

taking hypolipidemic drugs or supplements that affect lipid metabolism

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cynacol

    Dietary supplement

    Cynacol (developed by BioDue S.p.A.) containing, artichoke dry extract, naringin, Silybum marianum dry extract, flaxseed oil, vitamin E and sunflower oil, 2 capsules/day after dinner for 90 days

  • Metacol

    Dietary supplement

    Metacol (developed by BioDue S.p.A.) containing coenzyme Q10, monacolin k and flaxseed oil, 2 capsules/day after dinner for 90 days

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CynacolExperimental treatment 1 intervention
Group B: MetacolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

LDL Cholesterol

The primary outcome is to evaluate the change in LDL-C levels after 90 days of supplementation with Cynacol compared to Metacol

Time frame
3 months

Secondary outcomes

1

Lipid profile parameters different from LDL

to evaluate the variation of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C after 90 days of treatment with Cynacol compared to Metacol

Time frame
three months

Other outcomes

Sponsors and contacts

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