AFN: High Fat Diet: Oxidative and Cardiovascular Effects

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT00696228
Collaborator
Robert C. Atkins Foundation (Other)
144
1
4
64
2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo
  • Dietary Supplement: MUFA
  • Dietary Supplement: PUFA
  • Dietary Supplement: SFA
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
High Fat Diet: Oxidative Effects and Cardiovascular Risk
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. endothelial function [4 months]

Secondary Outcome Measures

  1. energy balance and body composition [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 40 Years
Sexes 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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heidi J. Silver, Research Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00696228
Other Study ID Numbers:
  • 071325
First Posted:
Jun 12, 2008
Last Update Posted:
Nov 10, 2020
Last Verified:
Nov 1, 2020

Study Results

No Results Posted as of Nov 10, 2020