- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696228
High Fat Diet: Oxidative and Cardiovascular Effects (AFN)
November 9, 2020 updated by: Heidi J. Silver, Vanderbilt University
High Fat Diet: Oxidative Effects and Cardiovascular Risk
To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance.
Study Type
Interventional
Enrollment (Actual)
144
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- BMI 30-39.9
- Female
- Age 21-40
Exclusion Criteria:
- Smoker
- Comorbid Disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: AFN A
High Fat Diet Placebo
|
Placebo
|
Experimental: AFN B
MUFA
|
MUFA
|
Experimental: AFN C
PUFA
|
PUFA
|
Experimental: AFN D
SFA
|
SFA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
endothelial function
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
energy balance and body composition
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Heidi J Silver, PhD, Vanderbilt University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Niswender KD, Fazio S, Gower BA, Silver HJ. Balanced high fat diet reduces cardiovascular risk in obese women although changes in adipose tissue, lipoproteins, and insulin resistance differ by race. Metabolism. 2018 May;82:125-134. doi: 10.1016/j.metabol.2018.01.020. Epub 2018 Jan 31.
- Silver HJ, Kang H, Keil CD, Muldowney JA 3rd, Kocalis H, Fazio S, Vaughan DE, Niswender KD. Consuming a balanced high fat diet for 16 weeks improves body composition, inflammation and vascular function parameters in obese premenopausal women. Metabolism. 2014 Apr;63(4):562-73. doi: 10.1016/j.metabol.2014.01.004. Epub 2014 Jan 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
June 9, 2008
First Submitted That Met QC Criteria
June 9, 2008
First Posted (Estimate)
June 12, 2008
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 071325
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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