Effects of Low and Moderate Fat Diets on Lipids, Inflammation and Vascular Reactivity in the Metabolic Syndrome

Completed · Not applicable

Conditions studied: Metabolic Syndrome X, Dyslipidemias

In brief

The metabolic syndrome consists of five concurrent conditions which increase risk of heart disease, stroke, and diabetes. Persons with the metabolic syndrome usually have high triglyceride and low HDL levels and are overweight. Low fat, high carbohydrate diets may not provide the same cholesterol-lowering benefits to obese individuals as they do to non-obese individuals. The purpose of this study is to compare the effects of a low fat, high carbohydrate diet versus a moderate fat, moderate carbohydrate diet on the heart, blood vessels, and cholesterol levels in individuals with metabolic syndrome.

Key facts

Study ID

NCT00362908

Run by

University of Washington

People needed

71

Starts

2006-09-01

Expected to finish

2010-06-01

Last updated by the study team

2010-10-28

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Metabolic Syndrome: individuals must have at least three of the following five criteria:
• Abdominal obesity greater than 90 cm in Asian men, greater than 102 cm in all other men, greater than 80 cm in Asian women, and greater than 88 cm in all other women
• Triglycerides greater than or equal to 150 mg/dL at two screening visits (Required for the purposes of this study, which focuses on the dyslipidemic phenotype)
• HDL cholesterol levels less than 40 mg/dL in men and less than 50 mg/dL in women
• Blood pressure levels greater than 130/85 mmHg or taking an allowed blood pressure medication at Visit 1 (see definition in exclusions below)
• Fasting glucose greater than or equal to 100mg/dL at Visit 1

You may not qualify if…

• LDL greater than or equal to 190 mg/dL
• Triglycerides greater than 500mg/dL at Visit 1
• Blood pressure over a mean of 150/95 at the two first visits
• Body mass index greater than 40 kg/m²
• Currently taking any lipid lowering medication other than statins
• Currently taking high doses of thiazide diuretics (greater than 50mg/day), or any other blood pressure medication in the past 4 weeks
• Use of plant sterols from sources such as Benecol or Take Control margarines in the past 4 weeks
• Use of any fish oil supplements in the week prior to screening
• Blood glucose greater than 140 mg/dL or use of diabetes medications
• Hospitalization for coronary disease in the last 6 months
• Use of nitroglycerin or other nitrates
• Unstable liver, renal, gastrointestinal or pulmonary disease or mental disease, or medically unstable for other reasons
• Alcohol intake greater than 2 drinks/day, any illegal drug use, smoking, chronic NSAID use or NSAID use within 5 days before the BAR study
• Pregnancy intended within one year or one year prior or currently lactating
• In reproductive age women, an irregular menstrual cycle (must have consistent menstrual cycle between 24 to 32 days)
• Use or expectation of use of oral or patch contraceptive
• Unable or unlikely to be able to comply with study requirements

Where it is running

• Northwest Lipid Research Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.