Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349765
Status:
COMPLETED
Last Update Posted:
2007-09-14
First Post:
2006-06-30
Brief Title:
Effects of Various Higher Fat and Lower Fat Snacks on Cardiovascular Risk Factors in Men and Women
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 SFAtrans 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 SFAtrans 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 serumplasma 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None