Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare how well a combination of borage and echium oils will reduce inflammation compared to fish oils and placebo oil in subjects that are diabetic or have metabolic syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: Brigham and Women's Hospital
• Treatments: Borage oil

Criteria

Inclusion Criteria:

• adults, aged 21 years or more with either diabetes or metabolic syndrome. metabolic syndrome defined by NCEP/ATPIII criteria; must have 3 out of 5 of the following risk factors: 1.central obesity, men-greater than or equal to 40 inches, women-greater than or equal to 35 inches; 2.fasting blood TG greater than or equal to 150mg/dl or be taking TG lowering medications; 3. blood HDL cholesterol, men less than 40 mg/dl, women less than 50 mg/dl; 4. blood pressure greater than or equal to 130/85 or on HTN medication 5. fasting glucose greater than or equal to 100 mg/dl.

• participants on statins or glucose lowering drugs if dosages are stable for 3 months

Exclusion criteria

• children/young adults less than 21 years of age

• currently using anti-inflammatory drugs including NSAIDS, oral/IV steroids or injection antiinflammatory drugs(for RA), aspirin greater than 100mg/day

• taking leukotriene receptor antagonists ( montelukast), tylenol or nasal/inhaled steroids OK.

• currently using niacin, fibrates or fish oil

• blood pressure greater than 170/100

• HB1Ac greater than 10%

• TG greater than 500 mg/dl

• myocardial infarction/vascular surgery/stroke within the past year

• any stage II,III,IV heart failure

• prior cholecystectomy

• end stage renal disease

• BMI less than 23 or greater than 45

• pregnancy

• alcohol use greater than 14 drinks per week

• current self reported tobacco or illicit drug use

• intolerance or allergy to fish oil

• participants taking insulin on QD or BID doses, stable for 3 months