NCT00696228

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

4.3 years

First QC Date

June 9, 2008

Last Update Submit

November 9, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • endothelial function

    4 months

Secondary Outcomes (1)

  • energy balance and body composition

    4 months

Study Arms (4)

AFN A

PLACEBO COMPARATOR

High Fat Diet Placebo

Dietary Supplement: Placebo

AFN B

EXPERIMENTAL

MUFA

Dietary Supplement: MUFA

AFN C

EXPERIMENTAL

PUFA

Dietary Supplement: PUFA

AFN D

EXPERIMENTAL

SFA

Dietary Supplement: SFA

Interventions

PlaceboDIETARY_SUPPLEMENT

Placebo

AFN A
MUFADIETARY_SUPPLEMENT

MUFA

AFN B
PUFADIETARY_SUPPLEMENT

PUFA

AFN C
SFADIETARY_SUPPLEMENT

SFA

AFN D

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Smoker
  • Comorbid Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

  • 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.

    PMID: 29382504DERIVED

  • 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.

    PMID: 24559846DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Heidi J Silver, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 12, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

US(1)