Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Metabolic Syndrome x

Intervention / Treatment
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* Drug: borage/echium oil combination
* Dietary Supplement: fish oil
* Dietary Supplement: corn oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: borage and echium oil combination<br>borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA | Drug: borage/echium oil combination<br>* borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA<br>* Other names: Croda borage oil, Crossential GLA TG40;|
| Active Comparator: fish oil<br>Croda 18:12 fish oil | Dietary Supplement: fish oil<br>* 1.6g/day EPA and 1.08g/day DHA<br>* Other names: Croda 18:12 fish oil;|
| Placebo Comparator: corn oil<br> | Dietary Supplement: corn oil<br>* contains 4.5 g/day linoleic acid<br>* Other names: Croda superrefined corn NF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Insulin |  | baseline | 
| Fasting Insulin | Fasting insulin data at 4 and 8 weeks was averaged. | 4 weeks and 8 weeks combined | 
| hsCRP | Changes in high sensitive C-reactive protein (hsCRP) were assessed. | baseline | 
| hsCRP | Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged.. | 4 weeks and 8 weeks combined | 
| Leptin |  | baseline | 
| Leptin | Data at 4 and 8 weeks was averaged. | 4 weeks and 8 weeks combined | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, metabolic syndrome, inflammation, botanical oils