Clinical trial NCT01145066: Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects
Official title: Modulation of Biomarkers and Gene Expression by Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Metabolic Syndrome x
Keywords: diabetes
metabolic syndrome
inflammation
botanical oils
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2010-06-16
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Fasting Insulin
timeFrame: baseline
measure: Fasting Insulin
timeFrame: 4 weeks and 8 weeks combined
measure: hsCRP
timeFrame: baseline
measure: hsCRP
timeFrame: 4 weeks and 8 weeks combined
measure: Leptin
timeFrame: baseline
measure: Leptin
timeFrame: 4 weeks and 8 weeks combined
Secondary outcomes:
measure: Serum Fatty Acids
timeFrame: baseline
measure: Serum Fatty Acids
timeFrame: 4 weeks and 8 weeks combined
measure: Pro and Anti-inflammatory Cytokines
timeFrame: baseline
measure: Pro and Anti-inflammatory Cytokines
timeFrame: 4 weeks and 8 weeks combined
measure: Fasting Glucose
timeFrame: baseline
measure: Fasting Glucose
timeFrame: 4 weeks and 8 weeks combined
measure: Hemoglobin Levels
timeFrame: baseline
measure: Hemoglobin Levels
timeFrame: 4 weeks and 8 weeks combined
measure: Adipose Derived Cytokines
timeFrame: 4 weeks
measure: PBMC Gene Expression
timeFrame: baseline
measure: PBMC Gene Expression
timeFrame: 4 weeks
measure: SNPs in DNA of Selected Genes
timeFrame: baseline
measure: SNPs in DNA of Selected Genes
timeFrame: 4 weeks
measure: PBMC Leukotriene Stimulation
timeFrame: baseline
measure: PBMC Leukotriene Stimulation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Floyd(Ski) H Chilton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee TC, Ivester P, Hester AG, Sergeant S, Case LD, Morgan T, Kouba EO, Chilton FH. The impact of polyunsaturated fatty acid-based dietary supplements on disease biomarkers in a metabolic syndrome/diabetes population. Lipids Health Dis. 2014 Dec 16;13:196. doi: 10.1186/1476-511X-13-196.