Effect of Saturated Fat on Large Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL)
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saturated Fat Diet
Saturated Fat Diet
Sponsored by
About this trial
This is an interventional basic science trial for Dyslipidemia focused on measuring Saturated fat, LDL size, Large LDL, Large HDL
Eligibility 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)
Sites / Locations
- Cholesterol Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low saturated fat diet
High saturated fat diet
Arm Description
Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 8%E saturated fat
Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat
Outcomes
Primary Outcome Measures
Large LDL (LDL I + 2a) (mg/dl)
Large HDL (HDL2b) (mg/dl)
LDL peak particle size
Secondary Outcome Measures
Triglycerides (mg/dl)
Total Cholesterol (mg/dl)
LDL cholesterol (mg/dl)
HDL cholesterol (mg/dl)
Apolipoprotein AI (mg/dl)
Apolipoprotein B (mg/dl)
Medium LDL (LDL2b) (mg/dl)
Small LDL (LDL3a) (mg/dl)
Hepatic Lipase Activity
Lipoprotein Lipase Activity
Cholesteryl Ester Transfer Protein Activity
Very Small LDL (LDL3b, 4a, 4b) (mg/dl)
Full Information
NCT ID
NCT00895141
First Posted
May 7, 2009
Last Updated
January 10, 2013
Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Dairy Management Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00895141
Brief Title
Effect of Saturated Fat on Large Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL)
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Dairy Management Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
Saturated fat, LDL size, Large LDL, Large HDL
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low saturated fat diet
Arm Type
Experimental
Arm Description
Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 8%E saturated fat
Arm Title
High saturated fat diet
Arm Type
Experimental
Arm Description
Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat
Intervention Type
Dietary Supplement
Intervention Name(s)
Saturated Fat Diet
Intervention Description
Moderate carbohydrate (35%E), moderate protein (25%E), high fat diet (40%E) with 8%E saturated fat
Intervention Type
Dietary Supplement
Intervention Name(s)
Saturated Fat Diet
Intervention Description
Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat
Primary Outcome Measure Information:
Title
Large LDL (LDL I + 2a) (mg/dl)
Time Frame
3 wk, 6 wk
Title
Large HDL (HDL2b) (mg/dl)
Time Frame
3 wk, 6 wk
Title
LDL peak particle size
Time Frame
3 wk, 6 wk
Secondary Outcome Measure Information:
Title
Triglycerides (mg/dl)
Time Frame
3 wk, 6 wk
Title
Total Cholesterol (mg/dl)
Time Frame
3 wk, 6 wk
Title
LDL cholesterol (mg/dl)
Time Frame
3 wk, 6 wk
Title
HDL cholesterol (mg/dl)
Time Frame
3 wk, 6 wk
Title
Apolipoprotein AI (mg/dl)
Time Frame
3 wk, 6 wk
Title
Apolipoprotein B (mg/dl)
Time Frame
3 wk, 6 wk
Title
Medium LDL (LDL2b) (mg/dl)
Time Frame
3 wk, 6 wk
Title
Small LDL (LDL3a) (mg/dl)
Time Frame
3 wk, 6 wk
Title
Hepatic Lipase Activity
Time Frame
3 wk, 6 wk
Title
Lipoprotein Lipase Activity
Time Frame
3 wk, 6 wk
Title
Cholesteryl Ester Transfer Protein Activity
Time Frame
3 wk, 6 wk
Title
Very Small LDL (LDL3b, 4a, 4b) (mg/dl)
Time Frame
3 wk, 6 wk
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Krauss, MD
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cholesterol Research Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28166253
Citation
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.
Results Reference
derived
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Effect of Saturated Fat on Large Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL)
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