BridgeMD
New treatment option for Hypercholesterolemia and Hyperlipidemia
Official title Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia
ClinicalTrials.gov ID: NCT06810466
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.