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
  Purpose

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 Intervention Phase
Diabetes
Metabolic Syndrome x
Dietary Supplement: borage/echium oil combination
Dietary Supplement: fish oil
Dietary Supplement: corn oil
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Modulation of Biomarkers and Gene Expression by Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects.

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: May 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: borage and echium oil combination
borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA
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
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145066

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

Additional Information:
No publications provided

Responsible Party: Floyd H. Chilton, Professor, Director of The Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01145066     History of Changes
Other Study ID Numbers: not yet assigned, P50 AT 0027820
Study First Received: June 14, 2010
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 16, 2014