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Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

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ClinicalTrials.gov Identifier: NCT01145066
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Diabetes Metabolic Syndrome x Drug: borage/echium oil combination Dietary Supplement: fish oil Dietary Supplement: corn oil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Modulation of Biomarkers and Gene Expression by Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects.
Study Start Date : May 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: borage and echium oil combination
borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA
Drug: 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

Active Comparator: fish oil
Croda 18:12 fish oil
Dietary Supplement: fish oil
1.6g/day EPA and 1.08g/day DHA
Other Name: Croda 18:12 fish oil

Placebo Comparator: corn oil Dietary Supplement: corn oil
contains 4.5 g/day linoleic acid
Other Name: Croda superrefined corn NF




Primary Outcome Measures :
  1. Fasting Insulin [ Time Frame: baseline ]
  2. Fasting Insulin [ Time Frame: 4 weeks and 8 weeks combined ]
    Fasting insulin data at 4 and 8 weeks was averaged.

  3. hsCRP [ Time Frame: baseline ]
    Changes in high sensitive C-reactive protein (hsCRP) were assessed.

  4. hsCRP [ Time Frame: 4 weeks and 8 weeks combined ]
    Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged..

  5. Leptin [ Time Frame: baseline ]
  6. Leptin [ Time Frame: 4 weeks and 8 weeks combined ]
    Data at 4 and 8 weeks was averaged.


Secondary Outcome Measures :
  1. Serum Fatty Acids [ Time Frame: baseline ]
  2. Serum Fatty Acids [ Time Frame: 4 weeks and 8 weeks combined ]
    Data at 4 and 8 weeks was averaged.

  3. Pro and Anti-inflammatory Cytokines [ Time Frame: baseline ]
  4. Pro and Anti-inflammatory Cytokines [ Time Frame: 4 weeks and 8 weeks combined ]
  5. Fasting Glucose [ Time Frame: baseline ]
  6. Fasting Glucose [ Time Frame: 4 weeks and 8 weeks combined ]
    Data at 4 and 8 weeks was averaged.

  7. Hemoglobin Levels [ Time Frame: baseline ]
  8. Hemoglobin Levels [ Time Frame: 4 weeks and 8 weeks combined ]
    Data at 4 and 8 weeks was averaged.

  9. Adipose Derived Cytokines [ Time Frame: 4 weeks ]
  10. PBMC Gene Expression [ Time Frame: baseline ]
  11. PBMC Gene Expression [ Time Frame: 4 weeks ]
  12. SNPs in DNA of Selected Genes [ Time Frame: baseline ]
  13. SNPs in DNA of Selected Genes [ Time Frame: 4 weeks ]
  14. PBMC Leukotriene Stimulation [ Time Frame: baseline ]
  15. PBMC Leukotriene Stimulation [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145066


Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Brigham and Women's Hospital
Investigators
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Principal Investigator: Floyd(Ski) H Chilton, Ph.D. Wake Forest University Health Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01145066     History of Changes
Other Study ID Numbers: IRB00007488
P50 AT 0027820 ( Other Grant/Funding Number: NCCAM )
First Posted: June 16, 2010    Key Record Dates
Results First Posted: December 25, 2018
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
diabetes
metabolic syndrome
inflammation
botanical oils

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases