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 |
---|---|---|
|
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
- endothelial function [4 months]
Secondary Outcome Measures
- 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