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

Lipids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549144
• Other study ID #: HDL-DIET
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 1, 2015

Study information

• Verified date: December 2021
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 1, 2015
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Lipids

Intervention

Dietary Supplement:
• Low fat/cholesterol diet
The low fat/cholesterol diet had 10% calories from fat and 150-200 mg of cholesterol per day.
• High fat/cholesterol diet
The high fat/cholesterol diet had 40% calories from fat and 250-300 mg of cholesterol per day

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dichlorofluorescein fluorescence slope		14 days
Secondary	hydroxyeicosatetraenoic acid		14 days
Secondary	hydroxyoctadecadienoic acid		14 days