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High Fat Diet: Oxidative and Cardiovascular Effects (AFN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Robert C. Atkins Foundation
Information provided by (Responsible Party):
Heidi J. Silver, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00696228
First received: June 9, 2008
Last updated: June 11, 2013
Last verified: June 2013
History of Changes
  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
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

Resource links provided by NLM:

U.S. FDA Resources

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
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

Ages Eligible for Study:   21 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Click here for more information about the study  This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013