Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 3, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 6, 2022
December 1, 2021
10 months
September 3, 2015
December 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dichlorofluorescein fluorescence slope
14 days
Secondary Outcomes (2)
hydroxyeicosatetraenoic acid
14 days
hydroxyoctadecadienoic acid
14 days
Study Arms (2)
High fat/cholesterol diet
EXPERIMENTALHigh-fat/high-cholesterol (HFHC) normocaloric diet for 14 days.
Low fat/cholesterol diet
EXPERIMENTALLow-fat/low-cholesterol (LFLC) normocaloric diet for 14 days.
Interventions
The low fat/cholesterol diet had 10% calories from fat and 150-200 mg of cholesterol per day.
The high fat/cholesterol diet had 40% calories from fat and 250-300 mg of cholesterol per day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Liver, heart, kidney, lung, infectious, neurological, psychiatric, endocrine, immunological or neoplastic diseases
- Chronic use of drugs or vitamin supplements
- Smoking
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56127, Italy
Related Publications (2)
Morgantini C, Trifiro S, Trico D, Meriwether D, Baldi S, Mengozzi A, Reddy ST, Natali A. A short-term increase in dietary cholesterol and fat intake affects high-density lipoprotein composition in healthy subjects. Nutr Metab Cardiovasc Dis. 2018 Jun;28(6):575-581. doi: 10.1016/j.numecd.2018.03.005. Epub 2018 Mar 19.
PMID: 29699812DERIVEDTrico D, Trifiro S, Mengozzi A, Morgantini C, Baldi S, Mari A, Natali A. Reducing Cholesterol and Fat Intake Improves Glucose Tolerance by Enhancing beta Cell Function in Nondiabetic Subjects. J Clin Endocrinol Metab. 2018 Feb 1;103(2):622-631. doi: 10.1210/jc.2017-02089.
PMID: 29095990DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Natali, Prof
Azienda Ospedaliero, Universitaria Pisana
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Andrea Natali
Study Record Dates
First Submitted
September 3, 2015
First Posted
September 15, 2015
Study Start
January 1, 2015
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
January 6, 2022
Record last verified: 2021-12