- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00349765
Effects of Various Higher Fat and Lower Fat Snacks on Cardiovascular Risk Factors in Men and Women.
September 12, 2007 updated by: University of Alabama at Birmingham
Cardiovascular Health Effects of Isocaloric Substitution of Polyunsaturated Fat Rich Snacks for Saturated and Trans Fat or Refined Carbohydrate Snacks in Moderately Hypercholesterolemic Individuals.
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment
42
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
total cholesterol
|
triglycerides
|
low-density lipoprotein cholesterol
|
high-density lipoprotein cholesterol
|
Secondary Outcome Measures
Outcome Measure |
---|
blood pressure
|
waist circumference
|
C-reactive protein
|
body fat
|
lipoprotein a
|
very low-density lipoprotein cholesterol
|
LDL pattern A or B
|
intramyocellular lipid
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marie-Pierre St-Onge, PhD, University of Alabama at Birmingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion
February 1, 2006
Study Registration Dates
First Submitted
June 30, 2006
First Submitted That Met QC Criteria
July 6, 2006
First Posted (Estimate)
July 10, 2006
Study Record Updates
Last Update Posted (Estimate)
September 14, 2007
Last Update Submitted That Met QC Criteria
September 12, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- X041217008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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