Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Floyd H. Chilton, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01145066
First received: June 14, 2010
Last updated: March 1, 2012
Last verified: March 2012

June 14, 2010
March 1, 2012
May 2009
March 2011   (final data collection date for primary outcome measure)
  • fasting insulin [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • fasting insulin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • fasting insulin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • hsCRP [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • hsCRP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • hsCRP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • leptin [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • leptin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • leptin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01145066 on ClinicalTrials.gov Archive Site
  • serum fatty acids [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • pro and anti-inflammatory cytokines [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • fasting glucose [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • hemoglobin 1Ac [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • adipose derived cytokines [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • circulating blood lipids and blood cell components [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • PBMC gene expression [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • SNPs in DNA of selected genes [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • PBMC leukotriene stimulation [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • serum fatty acids [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • serum fatty acids [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • pro and anti-inflammatory cytokines [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • pro and anti-inflammatory cytokines [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • fasting glucose [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • fasting glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • hemoglobin 1Ac [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • hemoglobin 1Ac [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • adipose derived cytokines [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • adipose derived cytokines [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • circulating blood lipids and blood cell components [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • circulating blood lipids and blood cell components [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • PBMC gene expression [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • PBMC gene expression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • SNPs in DNA of selected genes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • SNPs in DNA of selected genes [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • PBMC leukotriene stimulation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • PBMC leukotriene stimulation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects
Modulation of Biomarkers and Gene Expression by Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects.

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Diabetes
  • Metabolic Syndrome x
  • Dietary Supplement: borage/echium oil combination
    borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA
    Other Names:
    • Croda echium oil SR06379
    • Croda borage oil, Crossential GLA TG40
  • Dietary Supplement: fish oil
    1.6g/day EPA and 1.08g/day DHA
    Other Name: Croda 18:12 fish oil
  • Dietary Supplement: corn oil
    contains 4.5 g/day linoleic acid
    Other Name: Croda superrefined corn NF
  • Experimental: borage and echium oil combination
    borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA
    Intervention: Dietary Supplement: borage/echium oil combination
  • Active Comparator: fish oil
    Croda 18:12 fish oil
    Intervention: Dietary Supplement: fish oil
  • Placebo Comparator: corn oil
    Intervention: Dietary Supplement: corn oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01145066
not yet assigned, P50 AT 0027820
No
Floyd H. Chilton, Wake Forest University Baptist Medical Center
Wake Forest Baptist Health
Brigham and Women's Hospital
Principal Investigator: Floyd(Ski) H Chilton, Ph.D. Wake Forest School of Medicine
Wake Forest Baptist Health
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP