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Fat Effects in Women With Metabolic Syndrome (FEMMES II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01093560
First received: March 18, 2010
Last updated: August 3, 2011
Last verified: August 2011
History of Changes
  Purpose

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
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Flow Mediated Dilation at 4 hours post feeding [ Time Frame: four hours ] [ Designated as safety issue: No ]
    4 hours


Secondary Outcome Measures:
  • Adhesion molecules (VCAM and sICAM) [ Time Frame: 3 1/2 hours ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093560

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

No publications provided

Responsible Party: Pathmaja Paramsothy, MD, MS, University of Washington
ClinicalTrials.gov Identifier: NCT01093560     History of Changes
Other Study ID Numbers: 36899-D
Study First Received: March 18, 2010
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013