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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895141
• Other study ID #: MM3355
• Status: Completed
• Phase: N/A
• First received: May 7, 2009
• Last updated: January 10, 2013
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: January 2013
• Source: Children's Hospital & Research Center Oakland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Dietary Supplement:
• Saturated Fat Diet
Moderate carbohydrate (35%E), moderate protein (25%E), high fat diet (40%E) with 8%E saturated fat
• Saturated Fat Diet
Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat

Locations

Country	Name	City	State
United States	Cholesterol Research Center	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital & Research Center Oakland	Dairy Management Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Large LDL (LDL I + 2a) (mg/dl)		3 wk, 6 wk	No
Primary	Large HDL (HDL2b) (mg/dl)		3 wk, 6 wk	No
Primary	LDL peak particle size		3 wk, 6 wk	No
Secondary	Triglycerides (mg/dl)		3 wk, 6 wk	No
Secondary	Total Cholesterol (mg/dl)		3 wk, 6 wk	No
Secondary	LDL cholesterol (mg/dl)		3 wk, 6 wk	No
Secondary	HDL cholesterol (mg/dl)		3 wk, 6 wk	No
Secondary	Apolipoprotein AI (mg/dl)		3 wk, 6 wk	No
Secondary	Apolipoprotein B (mg/dl)		3 wk, 6 wk	No
Secondary	Medium LDL (LDL2b) (mg/dl)		3 wk, 6 wk	No
Secondary	Small LDL (LDL3a) (mg/dl)		3 wk, 6 wk	No
Secondary	Hepatic Lipase Activity		3 wk, 6 wk	No
Secondary	Lipoprotein Lipase Activity		3 wk, 6 wk	No
Secondary	Cholesteryl Ester Transfer Protein Activity		3 wk, 6 wk	No
Secondary	Very Small LDL (LDL3b, 4a, 4b) (mg/dl)		3 wk, 6 wk	No