We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

High Fat Diet: Oxidative and Cardiovascular Effects (AFN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00696228
First Posted: June 12, 2008
Last Update Posted: June 3, 2015
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.
Collaborator:
Robert C. Atkins Foundation
Information provided by (Responsible Party):
Heidi J. Silver, Vanderbilt University
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: High Fat Diet: Oxidative Effects and Cardiovascular Risk

Further study details as provided by Heidi J. Silver, Vanderbilt University:

Primary Outcome Measures:
  • endothelial function [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • energy balance and body composition [ Time Frame: 4 months ]

Enrollment: 144
Study Start Date: August 2008
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
Placebo
Experimental: AFN B
MUFA
Dietary Supplement: MUFA
MUFA
Experimental: AFN C
PUFA
Dietary Supplement: PUFA
PUFA
Experimental: AFN D
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoker
  • Comorbid Disease
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00696228


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

Additional Information:
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
First Submitted: June 9, 2008
First Posted: June 12, 2008
Last Update Posted: June 3, 2015
Last Verified: June 2015