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DyslipidemiaNCT00895141

Effect of Saturated Fat on Large Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL)

A study testing Saturated Fat Diet in people with Dyslipidemia, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to test whether increased saturated fat intake results in increased levels of larger LDL and HDL particles in individuals with LDL Pattern B. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Dyslipidemia
What is being tested?
Saturated Fat Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
Apr 2009to Apr 2011
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men or postmenopausal woman between 18-70 yrs
  • Body Mass Index between 25-35
  • Blood pressure <150/90
  • Non smoking
  • Agrees to consume no alcohol or dietary supplements during the study
  • LDL Subclass Pattern B
Show all 10Show fewer
  • Total cholesterol and LDLC ≤95th percentile for sex and age
  • Fasting triglycerides ≤ 500mg/dl
  • Fasting blood sugar < 126 mg/dl
  • At least 3 months weight stable

Who cannot join

  • History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin) in the last 5 years
  • Taking drugs known to affect lipid metabolism or hormones
  • Abnormal thyroid stimulating hormone (TSH)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cholesterol Research Center

    Berkeley, California, 94705

Other trials in United States

About this study

Official title: Changes in LDL and HDL With Increased Intake of Saturated Fat From Dairy Foods in Individuals With Atherogenic Dyslipidemia and LDL Subclass Pattern B

The purpose of the study is to test whether increased saturated fat intake results in increased levels of larger LDL and HDL particles in individuals with LDL Pattern B.

Read the detailed description

Increased saturated fat intake is known to elevate plasma levels of both low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C), however, less is know regarding the effect of saturated fat on lipoprotein subclasses. We previously showed that, in the context of a reduced carbohydrate diet, saturated fat induced increases in LDL cholesterol were apparently due to increases in large, more buoyant LDL without increases in small, dense LDL. This finding was supported by a previous dietary intervention study showing a correlation between saturated fat intake and large LDL. In both cases, this increase in large LDL was correlated with an increase in large HDL. In this study, we will test the following specific hypotheses regarding changes in plasma lipoproteins induced by a diet high in myristic acid and other saturated fats derived primarily from dairy sources in individuals with LDL subclass pattern B: 1) there will be a coordinate increase in levels of large HDL particles that are considered anti-atherogenic and large LDL particles that are less strongly associated with increased CVD risk than smaller LDL; 2) this change in lipoprotein profile will result in a higher proportion of pattern B individuals converting to LDL subclass pattern A (predominance of larger LDL); and 3) the coordinate increase in large HDL and LDL is due to a common underlying pathway. The latter hypothesis will be addressed by assaying cholesterol ester transfer protein (CETP), hepatic lipase (HL), and lipoprotein lipase (LPL).

Conditions
Dyslipidemia
Being tested
Saturated Fat Diet
Keywords
Saturated fat, LDL size, Large LDL, Large HDL
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saturated Fat DietDietary supplement

    Moderate carbohydrate (35%E), moderate protein (25%E), high fat diet (40%E) with 8%E saturated fat

  • Saturated Fat DietDietary supplement

    Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat

Study groups in NCT00895141
Study groupRoleWhat they receive
Low saturated fat dietExperimentalModerate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 8%E saturated fat
Receives: Dietary Supplement: Saturated Fat Diet
High saturated fat dietExperimentalModerate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat
Receives: Dietary Supplement: Saturated Fat Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Large LDL (LDL I + 2a) (mg/dl)

    Measured: 3 wk, 6 wk

  2. Large HDL (HDL2b) (mg/dl)

    Measured: 3 wk, 6 wk

  3. LDL peak particle size

    Measured: 3 wk, 6 wk

Secondary outcomes (12)

  1. Triglycerides (mg/dl)

    Measured: 3 wk, 6 wk

  2. Total Cholesterol (mg/dl)

    Measured: 3 wk, 6 wk

  3. LDL cholesterol (mg/dl)

    Measured: 3 wk, 6 wk

  4. HDL cholesterol (mg/dl)

    Measured: 3 wk, 6 wk

  5. Apolipoprotein AI (mg/dl)

    Measured: 3 wk, 6 wk

  6. Apolipoprotein B (mg/dl)

    Measured: 3 wk, 6 wk

  7. Medium LDL (LDL2b) (mg/dl)

    Measured: 3 wk, 6 wk

  8. Small LDL (LDL3a) (mg/dl)

    Measured: 3 wk, 6 wk

  9. Hepatic Lipase Activity

    Measured: 3 wk, 6 wk

  10. Lipoprotein Lipase Activity

    Measured: 3 wk, 6 wk

  11. Cholesteryl Ester Transfer Protein Activity

    Measured: 3 wk, 6 wk

  12. Very Small LDL (LDL3b, 4a, 4b) (mg/dl)

    Measured: 3 wk, 6 wk

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionSep 2010
  4. Study completionApr 2011

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00895141
Sponsor's protocol ID
MM3355
Status last verified
Jan 2013
First submitted
7 May 2009
Last updated
14 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • Chiu S, Williams PT, Krauss RM. Effects of a very high saturated fat diet on LDL particles in adults with atherogenic dyslipidemia: A randomized controlled trial. PLoS One. 2017 Feb 6;12(2):e0170664. doi: 10.1371/journal.pone.0170664. eCollection 2017.

    PubMed 28166253

Questions about this trial

What is this clinical trial studying?

A study testing Saturated Fat Diet in people with Dyslipidemia, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.

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 10 inclusion and 3 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 14 Jan 2013. 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 United States. 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?

Large LDL (LDL I + 2a) (mg/dl) (time frame: 3 wk, 6 wk). The study lists 3 primary outcomes in all. 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 NCT00895141, which also lists 1 linked publication.

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 14 Jan 2013.

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