Fat Effects in Women With Metabolic Syndrome (FEMMES II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01093560
Recruitment Status : Unknown
Verified August 2011 by University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : March 26, 2010
Last Update Posted : August 5, 2011
Information provided by:
University of Washington

Brief Summary:

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 or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: fat feeding Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Fat Effects in Women With Metabolic Syndrome
Study Start Date : March 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

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

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

Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Pathmaja Paramsothy, MD, MS, University of Washington Identifier: NCT01093560     History of Changes
Other Study ID Numbers: 36899-D
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: August 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