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NCT Number: NCT02549144

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

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.

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Key information

Conditions

Lipids

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low fat/cholesterol diet

Dietary Supplement

The low fat/cholesterol diet had 10% calories from fat and 150-200 mg of cholesterol per day.

High fat/cholesterol diet

Dietary Supplement

The high fat/cholesterol diet had 40% calories from fat and 250-300 mg of cholesterol per day

Primary outcomes

  1. Dichlorofluorescein fluorescence slope

    Time frame: 14 days

Secondary outcomes

  1. hydroxyeicosatetraenoic acid

    Time frame: 14 days

  2. hydroxyoctadecadienoic acid

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 15, 2015
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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