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
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
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
NCT ID
NCT00349765
First Posted
June 30, 2006
Last Updated
September 12, 2007
Sponsor
University of Alabama at Birmingham
Collaborators
SmartFoods, Inc.
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
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Effects of Various Higher Fat and Lower Fat Snacks on Cardiovascular Risk Factors in Men and Women.
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