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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02549144
Enrollment
14
Registered
2015-09-15
Start date
2015-01-01
Completion date
2015-12-01
Last updated
2022-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipids

Keywords

HDL biochemical composition and function

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.

Interventions

DIETARY_SUPPLEMENTLow fat/cholesterol diet

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

DIETARY_SUPPLEMENTHigh fat/cholesterol diet

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

Sponsors

Azienda Ospedaliero, Universitaria Pisana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Dichlorofluorescein fluorescence slope14 days

Secondary

MeasureTime frame
hydroxyeicosatetraenoic acid14 days
hydroxyoctadecadienoic acid14 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026