Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on Lipid Profile.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Desirée Victoria Montesinos
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Blood lipid profile
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
The aim of this randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels.
Detailed Description
The duration of the study will be 56 days during which the investigational product or placebo will be consumed according to the assignment. Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).
Investigators
Desirée Victoria Montesinos
Principal Investigator
Universidad Católica San Antonio de Murcia
Eligibility Criteria
Inclusion Criteria
- •Adults (age \> 18 YO)
- •Total cholesterol levels at screening ≥ 200 mg/dL
Exclusion Criteria
- •History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- •Use of prescribed medication which may interfere with study measurements.
- •Unwillingness or inability to comply with clinical trial procedures.
- •Subjects whose condition makes them ineligible for the study at the investigator's discretion.
- •Pregnant or having the wish to become pregnant, or lactating.
- •Recent participation in another nutritional or medical trial
Outcomes
Primary Outcomes
Blood lipid profile
Time Frame: Day 1, at 28 and 56 days
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides
Secondary Outcomes
- Oxidation markers(Day 1, at 28 and 56 days)
- Anthropometric parameters(Day 1, at 28 and 56 days)
- Body composition measures(Day 1, at 28 and 56 days)
- Dietary Intake(Day 1, at 28 and 56 days)
- Adherence to the Mediterranean diet(Day 1, at 28, and 56 days)
- Blood pressure(Day 1, at 28 and 56 days)
- Physical Activity(Day 1, at 28 and 56 days)
- Liver safety variables(Day 1, at 28 and 56 days)