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

December 16, 2021 updated by: Andrea Natali, Azienda Ospedaliero, Universitaria Pisana
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PI
      • Pisa, PI, Italy, 56127
        • Azienda Ospedaliero-Universitaria Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High fat/cholesterol diet
High-fat/high-cholesterol (HFHC) normocaloric diet for 14 days.
Dietary supplement: High fat/cholesterol diet
The high fat/cholesterol diet had 40% calories from fat and 250-300 mg of cholesterol per day
Experimental: Low fat/cholesterol diet
Low-fat/low-cholesterol (LFLC) normocaloric diet for 14 days.
Dietary supplement: Low fat/cholesterol diet
The low fat/cholesterol diet had 10% calories from fat and 150-200 mg of cholesterol per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dichlorofluorescein fluorescence slope
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
hydroxyeicosatetraenoic acid
Time Frame: 14 days
14 days
hydroxyoctadecadienoic acid
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Investigators

  • Principal Investigator: Andrea Natali, Prof, Azienda Ospedaliero, Universitaria Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HDL-DIET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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