High Fat Diet: Oxidative and Cardiovascular Effects

Phase 3

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: PUFA; Dietary Supplement: SFA; Dietary Supplement: MUFA

• Registration Number: NCT00696228
• Lead Sponsor: Vanderbilt University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-12
• Study Start: 2008-08
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

• BMI 30-39.9
• Female
• Age 21-40

Exclusion Criteria

• Smoker
• Comorbid Disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AFN A	Placebo	High Fat Diet Placebo
AFN C	PUFA	PUFA
AFN D	SFA	SFA
AFN B	MUFA	MUFA

Primary Outcome Measures

Name	Time	Method
endothelial function	4 months

Secondary Outcome Measures

Name	Time	Method
energy balance and body composition	4 months

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States