NCT00895141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

May 7, 2009

Last Update Submit

January 10, 2013

Conditions

Dyslipidemia

Keywords

Saturated fatLDL sizeLarge LDLLarge HDL

Outcome Measures

Primary Outcomes (3)

  • Large LDL (LDL I + 2a) (mg/dl)

    3 wk, 6 wk

  • Large HDL (HDL2b) (mg/dl)

    3 wk, 6 wk

  • LDL peak particle size

    3 wk, 6 wk

Secondary Outcomes (12)

  • Triglycerides (mg/dl)

    3 wk, 6 wk

  • Total Cholesterol (mg/dl)

    3 wk, 6 wk

  • LDL cholesterol (mg/dl)

    3 wk, 6 wk

  • HDL cholesterol (mg/dl)

    3 wk, 6 wk

  • Apolipoprotein AI (mg/dl)

    3 wk, 6 wk

  • +7 more secondary outcomes

Study Arms (2)

Low saturated fat diet

EXPERIMENTAL

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

Dietary Supplement: Saturated Fat Diet

High saturated fat diet

EXPERIMENTAL

Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat

Dietary Supplement: Saturated Fat Diet

Interventions

Saturated Fat DietDIETARY_SUPPLEMENT

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

Low saturated fat diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cholesterol Research Center

Berkeley, California, 94705, United States

Location

Related Publications (1)

  • 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.

    PMID: 28166253DERIVED

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ronald M Krauss, MD

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2010

Study Completion

April 1, 2011

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

US(1)