High Fat Diet: Oxidative and Cardiovascular Effects

NCT ID: NCT00696228

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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AFN A

High Fat Diet Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

AFN B

MUFA

Group Type EXPERIMENTAL

MUFA

Intervention Type DIETARY_SUPPLEMENT

MUFA

AFN C

PUFA

Group Type EXPERIMENTAL

PUFA

Intervention Type DIETARY_SUPPLEMENT

PUFA

AFN D

SFA

Group Type EXPERIMENTAL

SFA

Intervention Type DIETARY_SUPPLEMENT

SFA

Interventions

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Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

MUFA

MUFA

Intervention Type DIETARY_SUPPLEMENT

PUFA

PUFA

Intervention Type DIETARY_SUPPLEMENT

SFA

SFA

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Smoker
* Comorbid Disease
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Robert C. Atkins Foundation

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Heidi J. Silver

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heidi J Silver, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29382504 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24559846 (View on PubMed)

Other Identifiers

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071325

Identifier Type: -

Identifier Source: org_study_id