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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00895141
Enrollment
53
Registered
2009-05-08
Start date
2009-04-30
Completion date
2011-04-30
Last updated
2013-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

Saturated fat, LDL size, Large LDL, Large HDL

Brief 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.

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).

Interventions

DIETARY_SUPPLEMENTSaturated Fat Diet

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

Sponsors

Dairy Management Inc.
CollaboratorINDUSTRY
UCSF Benioff Children's Hospital Oakland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Large LDL (LDL I + 2a) (mg/dl)3 wk, 6 wk
Large HDL (HDL2b) (mg/dl)3 wk, 6 wk
LDL peak particle size3 wk, 6 wk

Secondary

MeasureTime frame
LDL cholesterol (mg/dl)3 wk, 6 wk
HDL cholesterol (mg/dl)3 wk, 6 wk
Apolipoprotein AI (mg/dl)3 wk, 6 wk
Apolipoprotein B (mg/dl)3 wk, 6 wk
Very Small LDL (LDL3b, 4a, 4b) (mg/dl)3 wk, 6 wk
Small LDL (LDL3a) (mg/dl)3 wk, 6 wk
Hepatic Lipase Activity3 wk, 6 wk
Lipoprotein Lipase Activity3 wk, 6 wk
Cholesteryl Ester Transfer Protein Activity3 wk, 6 wk
Medium LDL (LDL2b) (mg/dl)3 wk, 6 wk
Triglycerides (mg/dl)3 wk, 6 wk
Total Cholesterol (mg/dl)3 wk, 6 wk

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026