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

A

Azienda Ospedaliero, Universitaria Pisana

Status

Completed

Conditions

Lipids

Treatments

Dietary Supplement: Low fat/cholesterol diet
Dietary Supplement: High fat/cholesterol diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02549144
HDL-DIET

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 2 patient groups

High fat/cholesterol diet
Experimental group
Description:
High-fat/high-cholesterol (HFHC) normocaloric diet for 14 days.
Treatment:
Dietary Supplement: High fat/cholesterol diet
Low fat/cholesterol diet
Experimental group
Description:
Low-fat/low-cholesterol (LFLC) normocaloric diet for 14 days.
Treatment:
Dietary Supplement: Low fat/cholesterol diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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