Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

Recruitment & Eligibility

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
fish oil	fish oil	Croda 18:12 fish oil
borage and echium oil combination	borage/echium oil combination	borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA
corn oil	corn oil	-

Primary Outcome Measures

Name	Time	Method
hsCRP	4 weeks and 8 weeks combined	Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged..
Fasting Insulin	4 weeks and 8 weeks combined	Fasting insulin data at 4 and 8 weeks was averaged.
Leptin	4 weeks and 8 weeks combined	Data at 4 and 8 weeks was averaged.

Secondary Outcome Measures

Name	Time	Method
Fasting Glucose	4 weeks and 8 weeks combined	Data at 4 and 8 weeks was averaged.
SNPs in DNA of Selected Genes	4 weeks
Serum Fatty Acids	4 weeks and 8 weeks combined	Data at 4 and 8 weeks was averaged.
Hemoglobin Levels	4 weeks and 8 weeks combined	Data at 4 and 8 weeks was averaged.
Pro and Anti-inflammatory Cytokines	4 weeks and 8 weeks combined
Adipose Derived Cytokines	4 weeks
PBMC Gene Expression	4 weeks
PBMC Leukotriene Stimulation	4 weeks