This trial is active, not recruiting.

Condition metabolic syndrome
Treatment fat feeding
Sponsor University of Washington
Start date March 2010
End date August 2011
Trial size 10 participants
Trial identifier NCT01093560, 36899-D


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Saturated fat (control) n-3 Polyunsaturated fat (experimental) monounsaturated fat
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.

Primary Outcomes

Flow Mediated Dilation at 4 hours post feeding
time frame: four hours

Secondary Outcomes

Adhesion molecules (VCAM and sICAM)
time frame: 3 1/2 hours

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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)

Additional Information

Official title Fat Effects in Women With Metabolic Syndrome
Principal investigator Pathmaja Paramsothy, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by University of Washington.