High Fat Diet: Oxidative and Cardiovascular Effects (AFN)

This study is ongoing, but not recruiting participants.
Robert C. Atkins Foundation
Information provided by (Responsible Party):
Heidi J. Silver, Vanderbilt University
ClinicalTrials.gov Identifier:
First received: June 9, 2008
Last updated: June 11, 2013
Last verified: June 2013

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

Condition Intervention Phase
Dietary Supplement: Placebo
Dietary Supplement: MUFA
Dietary Supplement: PUFA
Dietary Supplement: SFA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: AFN A
High Fat Diet Placebo
Dietary Supplement: Placebo
Experimental: AFN B
Dietary Supplement: MUFA
Experimental: AFN C
Dietary Supplement: PUFA
Experimental: AFN D
Dietary Supplement: SFA

Detailed Description:

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


Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • BMI 30-39.9
  • Female
  • Age 21-40

Exclusion Criteria:

  • Smoker
  • Comorbid Disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00696228

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Robert C. Atkins Foundation
Principal Investigator: Heidi J Silver, PhD Vanderbilt University
  More Information

Additional Information:
No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heidi J. Silver, Research Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00696228     History of Changes
Other Study ID Numbers: 071325
Study First Received: June 9, 2008
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 30, 2015