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Completed

NCT Number: NCT00895141

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cholesterol Research Center

Berkeley, California, 94705, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Saturated Fat Diet

Dietary Supplement

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

Primary outcomes

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

    Time frame: 3 wk, 6 wk

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

    Time frame: 3 wk, 6 wk

  3. LDL peak particle size

    Time frame: 3 wk, 6 wk

Secondary outcomes

  1. Triglycerides (mg/dl)

    Time frame: 3 wk, 6 wk

  2. Total Cholesterol (mg/dl)

    Time frame: 3 wk, 6 wk

  3. LDL cholesterol (mg/dl)

    Time frame: 3 wk, 6 wk

  4. HDL cholesterol (mg/dl)

    Time frame: 3 wk, 6 wk

  5. Apolipoprotein AI (mg/dl)

    Time frame: 3 wk, 6 wk

  6. Apolipoprotein B (mg/dl)

    Time frame: 3 wk, 6 wk

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

    Time frame: 3 wk, 6 wk

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

    Time frame: 3 wk, 6 wk

  9. Hepatic Lipase Activity

    Time frame: 3 wk, 6 wk

  10. Lipoprotein Lipase Activity

    Time frame: 3 wk, 6 wk

  11. Cholesteryl Ester Transfer Protein Activity

    Time frame: 3 wk, 6 wk

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

    Time frame: 3 wk, 6 wk

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Collaborators

  • Dairy Management Inc.

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
May 8, 2009
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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