Fat Effects in Women With Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Fat Effects in Women With Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: fat feeding


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: young women with MetS<br>Saturated fat (control) n-3 Polyunsaturated fat (experimental) monounsaturated fat | Dietary Supplement: fat feeding<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, premenopausal women, fat feeding