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Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia

RecruitingNAAges 18 Years - 69 YearsAllIBSA Farmaceutici Italia Srl
NCT06810466 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The study population consists of 99 subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The participants will be divided into three groups: Group A: Test Product A (study product) Group B: Test Product B (comparative product) Placebo group: placebo The following visits are scheduled during the study: T-2 (day -35) - Screening visit, 5 weeks before T0 T-1 (day -28) - Enrollment visit, 4 weeks before T0 T0 (day 0) - Randomization visit, baseline T1 (day 56) - Interim visit, 8 weeks after T0 T2 (day 112) - Final visit, 16 weeks after T0 After the first 8 week

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📋 Eligibility rules (as published)
Inclusion Criteria: * Prevention of cardiovascular disease * Low cardiovascular risk (\< 5%) * Sub-optimal serum levels of LDL-C (130-136 mg/dl; 3.37-4.14 mmol/l) and/or non-HDL-C (160-190 mg/dl; 4.14-4.92 mmol/l) at T-2 * Signature of informed consent. Exclusion Criteria: * Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \>/= 5) * diabetes mellitus * Taking hypolipemiants, supplements or drugs that may involve lipid metabolism * Hypertension treatment not stabilized for at least 3 months * History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease * Any medical-surgical treatment that may limit adherence to the study protocol * Pregnant and/or breastfeeding women
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What it tests

  • Test Product A
  • Test Product B
  • Placebo
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Where

1 site
S. Orsola-Malpighi University Hospital
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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