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

This study has been completed.
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT00895141
First received: May 7, 2009
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Dyslipidemia
 Dietary Supplement: Saturated Fat Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Large LDL (LDL I + 2a) (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • Large HDL (HDL2b) (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • LDL peak particle size [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Triglycerides (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • Total Cholesterol (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • LDL cholesterol (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • HDL cholesterol (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • Apolipoprotein AI (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • Apolipoprotein B (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • Medium LDL (LDL2b) (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • Small LDL (LDL3a) (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • Hepatic Lipase Activity [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • Lipoprotein Lipase Activity [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • Cholesteryl Ester Transfer Protein Activity [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]
  • Very Small LDL (LDL3b, 4a, 4b) (mg/dl) [ Time Frame: 3 wk, 6 wk ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: April 2009
Study Completion Date: April 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low saturated fat diet
Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 8%E saturated fat
 Dietary Supplement: Saturated Fat Diet
Moderate carbohydrate (35%E), moderate protein (25%E), high fat diet (40%E) with 8%E saturated fat
Experimental: High saturated fat diet
Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat
 Dietary Supplement: Saturated Fat Diet
Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895141

Locations
United States, California
Cholesterol Research Center
Berkeley, California, United States, 94705
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Dairy Management Inc.
Investigators
Principal Investigator: Ronald M Krauss, MD Children's Hospital & Research Center Oakland
  More Information

No publications provided

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT00895141     History of Changes
Other Study ID Numbers: MM3355
Study First Received: May 7, 2009
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
Saturated fat
LDL size
Large LDL
Large HDL

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013