Actively Recruiting
Evaluation of Two Dietary Supplement Formulations on Lipid Profile in Mild Hypercholesterolemia: A Randomized, Placebo-controlled Clinical Trial
Led by IBSA Farmaceutici Italia Srl · Updated on 2025-02-05
99
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
IBSA Farmaceutici Italia Srl
Lead Sponsor
I
Informapro Srl
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different dietary supplement formulations on lipid profiles in adults with mild hypercholesterolemia who have not responded to the Mediterranean diet. This single-center, randomized, parallel-group, single-blind, placebo-controlled clinical study includes 99 participants and aims to compare the impact of these supplements on cholesterol levels and other cardiovascular risk markers. Participants are divided into three groups: one receiving an innovative formulation (Test Product A), another receiving a classic formulation (Test Product B), and a placebo group. All groups take their assigned product daily for the first 8 weeks during the double-blind phase. Afterward, all participants continue with Test Product A for an additional 8 weeks in an open-label phase to observe longer-term effects and whether differences between the initial groups change when all receive the same supplement. Participants will attend scheduled visits at screening (35 days before baseline), enrollment (28 days before baseline), randomization (baseline), interim visit at 8 weeks, and final visit at 16 weeks. Researchers will monitor various blood markers including LDL cholesterol, total cholesterol, HDL cholesterol, triglycerides, and apolipoprotein B, as well as blood pressure and body measurements. Compliance, tolerability, lifestyle adherence, and adverse events are also tracked throughout the study, which lasts about 16 weeks from baseline.
CONDITIONS
Brief Title
Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 69 years
- Mild hypercholesterolemia with LDL cholesterol between 130 and 136 mg/dl or non-HDL cholesterol between 160 and 190 mg/dl
- Low cardiovascular risk (less than 5%)
- Prevention of cardiovascular disease
- Signed informed consent
You will not qualify if you...
- History of cardiovascular disease or high cardiovascular risk (5% or greater)
- Diabetes mellitus
- Taking hypolipemiant drugs, supplements, or medications affecting lipid metabolism
- Unstable hypertension treatment (not stabilized for at least 3 months)
- Ongoing kidney, thyroid, gastrointestinal, muscle, or liver disease
- Any medical or surgical treatment limiting study adherence
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants take one of the dietary supplement formulations or placebo daily. After the first 8 weeks, all participants continue with the intake of Test Product A for an additional 8 weeks.
Visits at baseline, 8 weeks, and 16 weeks
Trial Site Locations
Total: 1 location
1
S. Orsola-Malpighi University Hospital
Bologna, Italy, Italy, 40138
Actively Recruiting
Research Team
A
Arrigo Francesco Giuseppe Cicero, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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