Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects



Status:Completed
Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:12/27/2018
Start Date:May 2009
End Date:March 2011

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Modulation of Biomarkers and Gene Expression by Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects.

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.


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
We found this trial at
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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