Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects

Not Applicable

Completed

• Conditions: Lipids
• Interventions: Dietary Supplement: High fat/cholesterol diet; Dietary Supplement: Low fat/cholesterol diet

• Registration Number: NCT02549144
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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 Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-11
• Study First Posted: 2015-09-15
• Primary Completion: 2015-11-01
• Study Completion: 2015-12-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2022-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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
• Smoking
• Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High fat/cholesterol diet	High fat/cholesterol diet	High-fat/high-cholesterol (HFHC) normocaloric diet for 14 days.
Low fat/cholesterol diet	Low fat/cholesterol diet	Low-fat/low-cholesterol (LFLC) normocaloric diet for 14 days.

Primary Outcome Measures

Name	Time	Method
Dichlorofluorescein fluorescence slope	14 days

Secondary Outcome Measures

Name	Time	Method
hydroxyeicosatetraenoic acid	14 days
hydroxyoctadecadienoic acid	14 days

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, PI, Italy