Fat Effects in Women With Metabolic Syndrome

NCT01093560 | Unknown

• 1 other identifier: 36899-D
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; premenopausal women; fat feeding

Outcome Measures

Primary Outcomes (1)

• Flow Mediated Dilation at 4 hours post feeding

  4 hours

  four hours

Secondary Outcomes (1)

• Adhesion molecules (VCAM and sICAM)

  3 1/2 hours

Study Arms (1)

young women with MetS

EXPERIMENTAL

1. Saturated fat (control) 2. n-3 Polyunsaturated fat (experimental) 3. monounsaturated fat

Dietary Supplement: fat feeding

Interventions

fat feeding DIETARY_SUPPLEMENT

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.

young women with MetS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female,
• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pathmaja Paramsothy, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 26, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 5, 2011

Record last verified: 2011-08

Locations

US (1)