Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects - Full Text View

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Metabolic Syndrome

Drug Information available for: Corn oil Fish oil

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

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

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 University Baptist Medical Center

Brigham and Women's Hospital

Investigators

Principal Investigator:

Floyd(Ski) H Chilton, Ph.D.

Wake Forest University

More Information

Additional Information:

Wake Forest University Center for Botanical Lipids This link exits the ClinicalTrials.gov site

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 University Baptist Medical Center:

diabetes
metabolic syndrome
inflammation
botanical oils

Additional relevant MeSH terms:

Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on May 16, 2013