Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Diabetes; Metabolic Syndrome x

Treatments: Dietary Supplement: corn oil; Dietary Supplement: fish oil; Drug: borage/echium oil combination

Study type: Interventional

Funder types: Other

Identifiers

NCT01145066

IRB00007488

P50 AT 0027820 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups, including a placebo group

borage and echium oil combination

Experimental group

Description:

borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA

Treatment:

Drug: borage/echium oil combination

fish oil

Active Comparator group

Description:

Croda 18:12 fish oil

Treatment:

Dietary Supplement: fish oil

corn oil

Placebo Comparator group

Treatment:

Dietary Supplement: corn oil