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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00349765
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : September 14, 2007
SmartFoods, Inc.
Information provided by:
University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Behavioral: higher fat, high polyunsaturated fat diet Behavioral: higher fat, high saturated and trans fat diet Behavioral: lower fat diet Phase 2

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  (Clinical Trial)
Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : March 2005
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. total cholesterol
  2. low-density lipoprotein cholesterol
  3. high-density lipoprotein cholesterol
  4. triglycerides

Secondary Outcome Measures :
  1. C-reactive protein
  2. lipoprotein a
  3. very low-density lipoprotein cholesterol
  4. LDL pattern A or B
  5. blood pressure
  6. body fat
  7. waist circumference
  8. intramyocellular lipid

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00349765

Sponsors and Collaborators
University of Alabama at Birmingham
SmartFoods, Inc.
Principal Investigator: Marie-Pierre St-Onge, PhD University of Alabama at Birmingham

Publications of Results: Identifier: NCT00349765     History of Changes
Other Study ID Numbers: X041217008
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: September 14, 2007
Last Verified: September 2007

Keywords provided by University of Alabama at Birmingham:
cardiovascular disease
saturated fat
trans fat
polyunsaturated fat
intramyocellular lipid

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases