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Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

Primary Purpose

Diabetes, Metabolic Syndrome x

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

borage/echium oil combination

fish oil

corn oil

About this trial

This is an interventional basic science trial for Diabetes focused on measuring diabetes, metabolic syndrome, inflammation, botanical oils

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wake Forest Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

borage and echium oil combination

fish oil

corn oil

Arm Description

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

Croda 18:12 fish oil

Outcomes

Primary Outcome Measures

Fasting Insulin

Fasting insulin data at 4 and 8 weeks was averaged.

hsCRP

Changes in high sensitive C-reactive protein (hsCRP) were assessed.

hsCRP

Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged..

Leptin

Data at 4 and 8 weeks was averaged.

Secondary Outcome Measures

Serum Fatty Acids

Data at 4 and 8 weeks was averaged.

Pro and Anti-inflammatory Cytokines

Fasting Glucose

Data at 4 and 8 weeks was averaged.

Hemoglobin Levels

Data at 4 and 8 weeks was averaged.

Adipose Derived Cytokines

PBMC Gene Expression

SNPs in DNA of Selected Genes

PBMC Leukotriene Stimulation

Full Information

NCT ID

NCT01145066

First Posted

June 14, 2010

Last Updated

July 17, 2019

Sponsor

Wake Forest University Health Sciences

Collaborators

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01145066

Brief Title

Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Metabolic Syndrome x

Keywords

diabetes, metabolic syndrome, inflammation, botanical oils

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

borage and echium oil combination

Arm Type

Experimental

Arm Description

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

Arm Title

fish oil

Arm Type

Active Comparator

Arm Description

Croda 18:12 fish oil

Arm Title

corn oil

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

borage/echium oil combination

Other Intervention Name(s)

Croda echium oil SR06379, Croda borage oil, Crossential GLA TG40

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

fish oil

Other Intervention Name(s)

Croda 18:12 fish oil

Intervention Description

1.6g/day EPA and 1.08g/day DHA

Intervention Type

Dietary Supplement

Intervention Name(s)

corn oil

Other Intervention Name(s)

Croda superrefined corn NF

Intervention Description

contains 4.5 g/day linoleic acid

Primary Outcome Measure Information:

Title

Fasting Insulin

Time Frame

baseline

Title

Fasting Insulin

Description

Fasting insulin data at 4 and 8 weeks was averaged.

Time Frame

4 weeks and 8 weeks combined

Title

hsCRP

Description

Changes in high sensitive C-reactive protein (hsCRP) were assessed.

Time Frame

baseline

Title

hsCRP

Description

Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged..

Time Frame

4 weeks and 8 weeks combined

Title

Leptin

Time Frame

baseline

Title

Leptin

Description

Data at 4 and 8 weeks was averaged.

Time Frame

4 weeks and 8 weeks combined

Secondary Outcome Measure Information:

Title

Serum Fatty Acids

Time Frame

baseline

Title

Serum Fatty Acids

Description

Data at 4 and 8 weeks was averaged.

Time Frame

4 weeks and 8 weeks combined

Title

Pro and Anti-inflammatory Cytokines

Time Frame

baseline

Title

Pro and Anti-inflammatory Cytokines

Time Frame

4 weeks and 8 weeks combined

Title

Fasting Glucose

Time Frame

baseline

Title

Fasting Glucose

Description

Data at 4 and 8 weeks was averaged.

Time Frame

4 weeks and 8 weeks combined

Title

Hemoglobin Levels

Time Frame

baseline

Title

Hemoglobin Levels

Description

Data at 4 and 8 weeks was averaged.

Time Frame

4 weeks and 8 weeks combined

Title

Adipose Derived Cytokines

Time Frame

4 weeks

Title

PBMC Gene Expression

Time Frame

baseline

Title

PBMC Gene Expression

Time Frame

4 weeks

Title

SNPs in DNA of Selected Genes

Time Frame

baseline

Title

SNPs in DNA of Selected Genes

Time Frame

4 weeks

Title

PBMC Leukotriene Stimulation

Time Frame

baseline

Title

PBMC Leukotriene Stimulation

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Floyd(Ski) H Chilton, Ph.D.

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25515553

Citation

Lee TC, Ivester P, Hester AG, Sergeant S, Case LD, Morgan T, Kouba EO, Chilton FH. The impact of polyunsaturated fatty acid-based dietary supplements on disease biomarkers in a metabolic syndrome/diabetes population. Lipids Health Dis. 2014 Dec 16;13:196. doi: 10.1186/1476-511X-13-196.

Results Reference

derived

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Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

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