search
Back to results

Effects of Various Higher Fat and Lower Fat Snacks on Cardiovascular Risk Factors in Men and Women.

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
higher fat, high polyunsaturated fat diet
higher fat, high saturated and trans fat diet
lower fat diet
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring cardiovascular disease, saturated fat, trans fat, polyunsaturated fat, diet, intramyocellular lipid

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    total cholesterol
    low-density lipoprotein cholesterol
    high-density lipoprotein cholesterol
    triglycerides

    Secondary Outcome Measures

    C-reactive protein
    lipoprotein a
    very low-density lipoprotein cholesterol
    LDL pattern A or B
    blood pressure
    body fat
    waist circumference
    intramyocellular lipid

    Full Information

    First Posted
    June 30, 2006
    Last Updated
    September 12, 2007
    Sponsor
    University of Alabama at Birmingham
    Collaborators
    SmartFoods, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00349765
    Brief Title
    Effects of Various Higher Fat and Lower Fat Snacks on Cardiovascular Risk Factors in Men and Women.
    Official Title
    Cardiovascular Health Effects of Isocaloric Substitution of Polyunsaturated Fat Rich Snacks for Saturated and Trans Fat or Refined Carbohydrate Snacks in Moderately Hypercholesterolemic Individuals.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Alabama at Birmingham
    Collaborators
    SmartFoods, Inc.

    4. Oversight

    5. Study Description

    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.
    Detailed Description
    The overall goals of this study are to determine whether snack foods rich in polyunsaturated fats (PUFA) produce beneficial effects on cardiovascular disease risk compared to snacks rich in saturated fats (SFA) and trans fats and snacks rich in refined carbohydrates. The primary objective of this study is to determine the effects of substituting n-6 PUFA (linoleic acid) from snack chips for SFA/trans fat and refined carbohydrate on serum lipids -principally LDL-C - and lipoproteins in moderately hypercholesterolemic men and women. A secondary objective is to assess effects on lipoprotein subclass particle size, intramyocellular lipids, and C-reactive protein (CRP). Forty-two men and women will be recruited to participate in a randomized, crossover, controlled feeding experiment for 3 periods of 4 weeks each. Each feeding phase will be separated by an 8-week washout period. The control diet will be a National Cholesterol Education Program Step 1 diet consisting of approximately 30% energy from total fat, <10% energy from SFA, 5% energy from PUFA, 15% energy from monounsaturated fatty acids (MUFA), 1% energy from trans fat, 55% energy from carbohydrates, and 15% energy from protein. To achieve an isocaloric substitution with PUFA, 300 kcal coming from low-fat, high-carbohydrate snacks will be removed from the Step 1 diet (NCEP diet) and replaced with 300 kcal of PUFA-rich snacks (LO diet). Similarly, 300 kcal from snacks rich in SFA/trans fat will replace the same 300 kcal from the high-carbohydrate from the Step 1 diet for the high SFA diet (SF diet). Subjects will consumed all foods provided by the GCRC and nothing else during each feeding phase. Breakfast and lunch meals will be consumed at the GCRC on weekdays and breakfast on Saturdays. All other meals will be packed and consumed at home. The primary study variable will be serum/plasma LDL-cholesterol. Secondary variables will include lipids and lipoproteins including total cholesterol (TC), HDL-cholesterol, VLDL-cholesterol, and triglycerides, and intramyocellular lipids. Exploratory variables will include assessment of lipid subclass particle size and CRP, a marker of systemic inflammation. Supportive variables will include fasting blood glucose and insulin, percent body fat mass, blood pressure and demographic information. All variables will be measured at baseline and endpoint of each feeding phase.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia
    Keywords
    cardiovascular disease, saturated fat, trans fat, polyunsaturated fat, diet, intramyocellular lipid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    42 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    higher fat, high polyunsaturated fat diet
    Intervention Type
    Behavioral
    Intervention Name(s)
    higher fat, high saturated and trans fat diet
    Intervention Type
    Behavioral
    Intervention Name(s)
    lower fat diet
    Primary Outcome Measure Information:
    Title
    total cholesterol
    Title
    low-density lipoprotein cholesterol
    Title
    high-density lipoprotein cholesterol
    Title
    triglycerides
    Secondary Outcome Measure Information:
    Title
    C-reactive protein
    Title
    lipoprotein a
    Title
    very low-density lipoprotein cholesterol
    Title
    LDL pattern A or B
    Title
    blood pressure
    Title
    body fat
    Title
    waist circumference
    Title
    intramyocellular lipid

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marie-Pierre St-Onge, PhD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17556685
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Effects of Various Higher Fat and Lower Fat Snacks on Cardiovascular Risk Factors in Men and Women.

    We'll reach out to this number within 24 hrs