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High Fat Diet: Oxidative and Cardiovascular Effects (AFN)

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ClinicalTrials.gov Identifier: NCT00696228
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Robert C. Atkins Foundation
Information provided by (Responsible Party):
Heidi J. Silver, Vanderbilt University

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
Obesity 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 Type : Interventional  (Clinical Trial)
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 : August 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

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




Primary Outcome Measures :
  1. endothelial function [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. energy balance and body composition [ Time Frame: 4 months ]


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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 30-39.9
  • Female
  • Age 21-40

Exclusion Criteria:

  • Smoker
  • Comorbid Disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015