Fat Effects in Women With Metabolic Syndrome

Not Applicable

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: fat feeding

• Registration Number: NCT01093560
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-26
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-05
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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,

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
young women with MetS	fat feeding	1. Saturated fat (control) 2. n-3 Polyunsaturated fat (experimental) 3. monounsaturated fat

Primary Outcome Measures

Name	Time	Method
Flow Mediated Dilation at 4 hours post feeding	four hours	4 hours

Secondary Outcome Measures

Name	Time	Method
Adhesion molecules (VCAM and sICAM)	3 1/2 hours

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States