Clinical trial NCT01093560: Fat Effects in Women With Metabolic Syndrome
Official title: Fat Effects in Women With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
premenopausal women
fat feeding
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility 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)

Primary outcomes:
measure: Flow Mediated Dilation at 4 hours post feeding
timeFrame: four hours
Secondary outcomes:
measure: Adhesion molecules (VCAM and sICAM)
timeFrame: 3 1/2 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Pathmaja Paramsothy, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: