Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145066
• Other study ID #: IRB00007488
• Secondary ID: P50 AT 0027820
• Status: Completed
• Phase: Phase 2
• Start date: May 2009
• Est. completion date: March 2011

Study information

• Verified date: December 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

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

Related Conditions & MeSH terms

• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome x
• Syndrome

Intervention

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

Dietary Supplement:
• fish oil
1.6g/day EPA and 1.08g/day DHA
• corn oil
contains 4.5 g/day linoleic acid

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Insulin		baseline
Primary	Fasting Insulin	Fasting insulin data at 4 and 8 weeks was averaged.	4 weeks and 8 weeks combined
Primary	hsCRP	Changes in high sensitive C-reactive protein (hsCRP) were assessed.	baseline
Primary	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
Primary	Leptin		baseline
Primary	Leptin	Data at 4 and 8 weeks was averaged.	4 weeks and 8 weeks combined
Secondary	Serum Fatty Acids		baseline
Secondary	Serum Fatty Acids	Data at 4 and 8 weeks was averaged.	4 weeks and 8 weeks combined
Secondary	Pro and Anti-inflammatory Cytokines		baseline
Secondary	Pro and Anti-inflammatory Cytokines		4 weeks and 8 weeks combined
Secondary	Fasting Glucose		baseline
Secondary	Fasting Glucose	Data at 4 and 8 weeks was averaged.	4 weeks and 8 weeks combined
Secondary	Hemoglobin Levels		baseline
Secondary	Hemoglobin Levels	Data at 4 and 8 weeks was averaged.	4 weeks and 8 weeks combined
Secondary	Adipose Derived Cytokines		4 weeks
Secondary	PBMC Gene Expression		baseline
Secondary	PBMC Gene Expression		4 weeks
Secondary	SNPs in DNA of Selected Genes		baseline
Secondary	SNPs in DNA of Selected Genes		4 weeks
Secondary	PBMC Leukotriene Stimulation		baseline
Secondary	PBMC Leukotriene Stimulation		4 weeks