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Fat Effects in Women With Metabolic Syndrome (FEMMES II)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by University of Washington.
Recruitment status was:  Active, not recruiting
Information provided by:
University of Washington Identifier:
First received: March 18, 2010
Last updated: August 3, 2011
Last verified: August 2011

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.

Condition Intervention
Metabolic Syndrome Dietary Supplement: fat feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Fat Effects in Women With Metabolic Syndrome

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Flow Mediated Dilation at 4 hours post feeding [ Time Frame: four hours ]
    4 hours

Secondary Outcome Measures:
  • Adhesion molecules (VCAM and sICAM) [ Time Frame: 3 1/2 hours ]

Estimated Enrollment: 10
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)
Arms Assigned Interventions
Experimental: young women with MetS
  1. Saturated fat (control)
  2. n-3 Polyunsaturated fat (experimental)
  3. monounsaturated fat
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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female,
  • 18-50 years of age,
  • Pre-menopausal,
  • Weight stable for at least 3 months,
  • Not planning to lose or gain weight for 3 months,
  • Meets the following 3/5 criteria for metabolic syndrome:

    • increased blood sugar
    • increased blood fats (triglycerides),
    • increased blood pressure,
    • decreased good cholesterol (HDL-C).
    • increased waist circumference,

Exclusion Criteria:

  • History of diabetes mellitus
  • Fasting glucose ≥ 126 mg/dL
  • History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)
  • Pregnant or planning a pregnancy within the study period
  • Fasting triglycerides > 500 mg/dL
  • Currently taking lipid lowering medications**
  • Oral or patch hormone contraception**
  • Currently taking vaso-active (blood pressure) medications**
  • SBP ≥ 140 and/or DBP ≥90 mm Hg or taking blood pressure lowering Rx
  • Chronic use of aspirin (prn use is allowed)
  • Chronic use of non-steroidal anti-inflammatory medications (prn use is allowed)
  • Tobacco use within 6 months of starting study
  • Participation in another clinical trial within the last 30 days
  • History of active gall bladder disease
  • History of digestive or malabsorptive disease requiring treatment or surgery
  • Moderate to severe lactose intolerance
  • Milk Allergy
  • Walnut Allergy or Nut Allergy
  • Coconut allergy

(**) Drugs within the following classifications are exclusionary: Lipid lowering, beta blockers, ACE inhibitors, angiotensin receptor blockers, diuretics, calcium channel blockers, alpha blockers, nitrates, hormone contraception includes patch or oral hormone contraception (Hormone containing IUDs or vaginal rings are okay)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01093560

United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Principal Investigator: Pathmaja Paramsothy, MD, MS University of Washington
  More Information

Responsible Party: Pathmaja Paramsothy, MD, MS, University of Washington Identifier: NCT01093560     History of Changes
Other Study ID Numbers: 36899-D
Study First Received: March 18, 2010
Last Updated: August 3, 2011

Keywords provided by University of Washington:
metabolic syndrome
premenopausal women
fat feeding

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on September 21, 2017