Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Dichlorofluorescein fluorescence slope
Study Overview
Brief Summary
In this study the investigators aimed at measuring the effect of a two-week high-fat/high-cholesterol (HFHC) normocaloric diet on HDL particles biochemical composition and HDL function compared to a two-week low-fat/low-cholesterol (LFLC) normocaloric diet.
Detailed Description
HDL particles can change their composition and function in response to a variety of pathological conditions and environmental stimuli. It has been previously shown that a western diet is able to drastically modify biochemical composition, anti-inflammatory and anti-oxidant properties of HDL in animals. In humans little is known on the role of diet on HDL function and composition.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects ≥ 18 and ≤40 years of age
- •Lean or overweight (BMI: 18 to 29,9 kg/m2)
- •Normal liver and kidney function
- •Normal thyroid function
- •Stable weight in the last 3 months
- •Read and understood the informed consent form and signed it voluntarily
Exclusion Criteria
- •Liver, heart, kidney, lung, infectious, neurological, psychiatric, endocrine, immunological or neoplastic diseases
- •Chronic use of drugs or vitamin supplements
- •Pregnancy or lactation
Outcomes
Primary Outcomes
Dichlorofluorescein fluorescence slope
Time Frame: 14 days
Secondary Outcomes
- hydroxyeicosatetraenoic acid(14 days)
- hydroxyoctadecadienoic acid(14 days)
Investigators
Andrea Natali
Professor Andrea Natali
Azienda Ospedaliero, Universitaria Pisana