Tests two dietary supplements for high cholesterol in adults
Compares two supplement formulations and a placebo in adults with mild high cholesterol.
Plain-language title generated from the registry record
Registry title: Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia
Key facts
- Where
- Bologna, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 69 years old?
Source: NCT06810466, who can take part
Where in Italy
- S. Orsola-Malpighi University hospitalBologna, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IBSA Farmaceutici Italia Srl
- Trial code
- NCT06810466
- Record updated
- 5 February 2025
- Original description
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.Read full original descriptionShow less
A Single-blind, Parallel-group, Randomized, Placebo-controlled Clinical Trial, to Evaluate the Effects of Two Different Formulations of a Dietary Supplement on the Lipid Profile in Subjects with Mild Hypercholesterolemia
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 weeks of the study (double-blind), all three groups will continue with only Product A for an additional 8 weeks. This experimental design aims to highlight whether any differences between Test Product A and Test Product B observed during the first 8 weeks can be minimized when both arms receive the same treatment. Additionally, the effect of Product A will be observed at 8 and 16 weeks, thus providing efficacy data over a longer treatment period. This may also provide insights into the potential achievement of a plateau. Regarding the placebo group, it will be possible to distinguish the effect of the diet alone from the combined effect of the diet and supplementation with Test Product A.
Inclusion: 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: Taking hypolipemiants, supplements or drugs that may involve lipid metabolism; Any medical-surgical treatment that may limit adherence to the study protocol; Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk >/= 5); diabetes mellitus; Hypertension treatment not stabilized for at least 3 months; History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease; Pregnant and/or breastfeeding women.