Fat Effects in Women With Metabolic Syndrome (FEMMES II)

August 3, 2011 updated by: University of Washington

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow Mediated Dilation at 4 hours post feeding
Time Frame: four hours
4 hours
four hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Adhesion molecules (VCAM and sICAM)
Time Frame: 3 1/2 hours
3 1/2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Pathmaja Paramsothy, MD, MS, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Estimate)

August 5, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36899-D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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