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
  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:


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
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, see Learn About Clinical Studies.

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:
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

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

ClinicalTrials.gov processed this record on July 20, 2014