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

Launched by IBSA FARMACEUTICI ITALIA SRL · Jan 30, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of two different dietary supplement formulations on cholesterol levels in individuals with mild high cholesterol (hypercholesterolemia) who haven't seen improvements from following the Mediterranean diet. The study involves 99 participants who will be divided into three groups: one group will receive Test Product A, another will receive Test Product B, and a third group will receive a placebo (a treatment with no active ingredients). The trial will last for 16 weeks, with the first 8 weeks being a double-blind phase where neither the participants nor the researchers know who is receiving which treatment, followed by 8 weeks where all groups will receive Test Product A.

To be eligible for this study, participants should be generally healthy adults between the ages of 65 and 74, with low cardiovascular risk and specific cholesterol levels that are not improving with diet alone. They should not have any existing cardiovascular diseases or other serious health conditions. Participants can expect several visits over the course of the study, where their cholesterol levels will be monitored. This research aims to provide valuable information about how dietary supplements may help manage cholesterol levels when diet alone isn't enough.

Gender

ALL

Eligibility criteria

• 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