Fat Effects in Women With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— FEMMES II  

Official title:

Fat Effects in Women With Metabolic Syndrome

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01093560
• Other study ID #: 36899-D
• Status: Unknown status
• Phase: N/A
• First received: March 18, 2010
• Last updated: August 3, 2011
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: August 2011
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow Mediated Dilation at 4 hours post feeding	4 hours	four hours
Secondary	Adhesion molecules (VCAM and sICAM)		3 1/2 hours