LipidsNCT02549144
Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects
A study testing Low fat/cholesterol diet and High fat/cholesterol diet in people with Lipids, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipids
- What is being tested?
- Low fat/cholesterol diet and High fat/cholesterol diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2015to 1 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Liver, heart, kidney, lung, infectious, neurological, psychiatric, endocrine, immunological or neoplastic diseases
- Chronic use of drugs or vitamin supplements
- Smoking
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lipids
- Being tested
- Low fat/cholesterol diet, High fat/cholesterol diet
- Keywords
- HDL biochemical composition and function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat/cholesterol dietDietary supplement
The low fat/cholesterol diet had 10% calories from fat and 150-200 mg of cholesterol per day.
High fat/cholesterol dietDietary supplement
The high fat/cholesterol diet had 40% calories from fat and 250-300 mg of cholesterol per day
| Study group | Role | What they receive |
|---|---|---|
| High fat/cholesterol diet | Experimental | High-fat/high-cholesterol (HFHC) normocaloric diet for 14 days. Receives: Dietary Supplement: High fat/cholesterol diet |
| Low fat/cholesterol diet | Experimental | Low-fat/low-cholesterol (LFLC) normocaloric diet for 14 days. Receives: Dietary Supplement: Low fat/cholesterol diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dichlorofluorescein fluorescence slope
Measured: 14 days
Secondary outcomes (2)
hydroxyeicosatetraenoic acid
Measured: 14 days
hydroxyoctadecadienoic acid
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study start1 Jan 2015
- Primary completion1 Nov 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LipidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natali, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Andrea Natali, Prof, Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549144
- Sponsor's protocol ID
- HDL-DIET
- Status last verified
- Dec 2021
- First submitted
- 3 Sep 2015
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29699812Trico 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.
PubMed 29095990
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02549144
- Acronym / sponsor ID
- HDL-DIET
- Conditions
- Lipids
- Keywords
- HDL biochemical composition and function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat/cholesterol diet | Experimental | Dietary Supplement: High fat/cholesterol dietHigh-fat/high-cholesterol (HFHC) normocaloric diet for 14 days. |
| Low fat/cholesterol diet | Experimental | Dietary Supplement: Low fat/cholesterol dietLow-fat/low-cholesterol (LFLC) normocaloric diet for 14 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Liver, heart, kidney, lung, infectious, neurological, psychiatric, endocrine, immunological or neoplastic diseases
- Chronic use of drugs or vitamin supplements
- Smoking
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low fat/cholesterol dietThe low fat/cholesterol diet had 10% calories from fat and 150-200 mg of cholesterol per day. | Dietary supplement | Low fat/cholesterol diet |
| High fat/cholesterol dietThe high fat/cholesterol diet had 40% calories from fat and 250-300 mg of cholesterol per day | Dietary supplement | High fat/cholesterol diet |
Primary outcome
Dichlorofluorescein fluorescence slope
Time frame: 14 days
2 secondary outcomes
hydroxyeicosatetraenoic acid
Time frame: 14 days
hydroxyoctadecadienoic acid
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Derived from this study: PubMed 29699812Morgantini 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.
- Derived from this study: PubMed 29095990Trico 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natali, Prof principal investigator
Azienda Ospedaliero, Universitaria Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fat/cholesterol diet and High fat/cholesterol diet in people with Lipids, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dichlorofluorescein fluorescence slope (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02549144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.