Fat Effects in Women With Metabolic Syndrome (FEMMES II)
Recruitment status was: Active, not recruiting
Among 10 premenopausal women with Metabolic Syndrome:
Specific Aim 1: Compare the effects of acute fat feeding on flow mediated dilation (FMD) as measured by brachial artery reactivity among three fat challenges (saturated fat vs. monounsaturated fat (MUFA) vs. polyunsaturated fat (PUFA)at 4 hours post feeding. Hypothesis Saturated fat feeding will impair FMD but MUFA and PUFA feeding will not.
Specific Aim 2: Compare the effects of acute feeding on vascular inflammation as measured by VCAM and sICAM among three fat challenges at 3 1/2 hours post feeding.
Hypothesis: Saturated fat feeding will increase vascular inflammation but MUFA and PUFA will not.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
|Official Title:||Fat Effects in Women With Metabolic Syndrome|
- Flow Mediated Dilation at 4 hours post feeding [ Time Frame: four hours ] [ Designated as safety issue: No ]4 hours
- Adhesion molecules (VCAM and sICAM) [ Time Frame: 3 1/2 hours ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: young women with MetS
Dietary Supplement: fat feeding
Each feeding will consist of 473 mL of nonfat milk and 50 gms oil. The oil will be high in saturated fat, monounsaturated fat or polyunsaturated fat.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093560
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Pathmaja Paramsothy, MD, MS||University of Washington|