High Fat Diet: Oxidative and Cardiovascular Effects - Full Text View

High Fat Diet: Oxidative and Cardiovascular Effects (AFN)

This study is currently recruiting participants.

Verified by Vanderbilt University, December 2008

Sponsors and Collaborators:	Vanderbilt University Robert C. Atkins Foundation
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00696228

Purpose

To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance.

Condition	Intervention	Phase
Obesity	Dietary Supplement: Placebo Dietary Supplement: MUFA Dietary Supplement: PUFA Dietary Supplement: SFA	Phase III

MedlinePlus related topics: Dietary Supplements Obesity

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	High Fat Diet: Oxidative Effects and Cardiovascular Risk

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

endothelial function [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

energy balance and body composition [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	164
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AFN A: Placebo Comparator High Fat Diet Placebo	Dietary Supplement: Placebo Placebo
AFN B: Experimental MUFA	Dietary Supplement: MUFA MUFA
AFN C: Experimental PUFA	Dietary Supplement: PUFA PUFA
AFN D: Experimental SFA	Dietary Supplement: SFA SFA

Detailed Description:

To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696228

Contacts

Contact: Heidi J Silver, PhD

615-936-1299

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Heidi J Silver, PhD 615-936-1299 heidi.j.silver@vanderbilt.edu
Principal Investigator: Heidi J Silver, PhD

Sponsors and Collaborators

Vanderbilt University

Robert C. Atkins Foundation

Investigators

Principal Investigator:

Heidi J Silver, PhD

Vanderbilt University

More Information

Click here for more information about the study This link exits the ClinicalTrials.gov site

Responsible Party:	Vanderbilt University ( Heidi J. Silver )
Study ID Numbers:	071325
Study First Received:	June 9, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00696228
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 15, 2009