NCT00349765

Brief Summary

The purpose of this study is to determine whether snacks differing in fat amount and type result in changes in cardiovascular disease risk factors in men and women who have mildly elevated cholesterol levels. Our hypothesis is that a diet containing snacks rich in polyunsaturated fats lead to a more favorable cardiovascular disease risk profile than a diet containing snacks rich in saturated and trans fats or one containing low-fat snacks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

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

March 1, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
Last Updated

September 14, 2007

Status Verified

September 1, 2007

First QC Date

June 30, 2006

Last Update Submit

September 12, 2007

Conditions

Hypercholesterolemia

Keywords

cardiovascular diseasesaturated fattrans fatpolyunsaturated fatdietintramyocellular lipid

Outcome Measures

Primary Outcomes (4)

  • total cholesterol

  • low-density lipoprotein cholesterol

  • high-density lipoprotein cholesterol

  • triglycerides

Secondary Outcomes (8)

  • C-reactive protein

  • lipoprotein a

  • very low-density lipoprotein cholesterol

  • LDL pattern A or B

  • blood pressure

  • +3 more secondary outcomes

Interventions

higher fat, high polyunsaturated fat dietBEHAVIORAL
higher fat, high saturated and trans fat dietBEHAVIORAL
lower fat dietBEHAVIORAL

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 19-65
  • body mass index 20-35
  • weight stable for at least 3 months
  • low-density lipoprotein cholesterol 130-180 mg/dL
  • triglycerides \< 150 mg/dL
  • glucose \< 126 mg/dL

You may not qualify if:

  • smokers
  • type 1 diabetes
  • type 2 diabetes
  • use of lipid-lowering medications
  • hypertension
  • pregnancy
  • lactation
  • planning to become pregnant during the period of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • St-Onge MP, Aban I, Bosarge A, Gower B, Hecker KD, Allison DB. Snack chips fried in corn oil alleviate cardiovascular disease risk factors when substituted for low-fat or high-fat snacks. Am J Clin Nutr. 2007 Jun;85(6):1503-10. doi: 10.1093/ajcn/85.6.1503.

    PMID: 17556685RESULT

MeSH Terms

Conditions

HypercholesterolemiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Marie-Pierre St-Onge, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 10, 2006

Study Start

March 1, 2005

Study Completion

February 1, 2006

Last Updated

September 14, 2007

Record last verified: 2007-09