Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

July 17, 2019 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Croda 18:12 fish oil
Placebo Comparator: corn oil
Dietary supplement: corn oil
contains 4.5 g/day linoleic acid
Other Names:
  • Croda superrefined corn NF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Insulin
Time Frame: baseline
baseline
Fasting Insulin
Time Frame: 4 weeks and 8 weeks combined
Fasting insulin data at 4 and 8 weeks was averaged.
4 weeks and 8 weeks combined
hsCRP
Time Frame: baseline
Changes in high sensitive C-reactive protein (hsCRP) were assessed.
baseline
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..
4 weeks and 8 weeks combined
Leptin
Time Frame: baseline
baseline
Leptin
Time Frame: 4 weeks and 8 weeks combined
Data at 4 and 8 weeks was averaged.
4 weeks and 8 weeks combined

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Fatty Acids
Time Frame: baseline
baseline
Serum Fatty Acids
Time Frame: 4 weeks and 8 weeks combined
Data at 4 and 8 weeks was averaged.
4 weeks and 8 weeks combined
Pro and Anti-inflammatory Cytokines
Time Frame: baseline
baseline
Pro and Anti-inflammatory Cytokines
Time Frame: 4 weeks and 8 weeks combined
4 weeks and 8 weeks combined
Fasting Glucose
Time Frame: baseline
baseline
Fasting Glucose
Time Frame: 4 weeks and 8 weeks combined
Data at 4 and 8 weeks was averaged.
4 weeks and 8 weeks combined
Hemoglobin Levels
Time Frame: baseline
baseline
Hemoglobin Levels
Time Frame: 4 weeks and 8 weeks combined
Data at 4 and 8 weeks was averaged.
4 weeks and 8 weeks combined
Adipose Derived Cytokines
Time Frame: 4 weeks
4 weeks
PBMC Gene Expression
Time Frame: baseline
baseline
PBMC Gene Expression
Time Frame: 4 weeks
4 weeks
SNPs in DNA of Selected Genes
Time Frame: baseline
baseline
SNPs in DNA of Selected Genes
Time Frame: 4 weeks
4 weeks
PBMC Leukotriene Stimulation
Time Frame: baseline
baseline
PBMC Leukotriene Stimulation
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Floyd(Ski) H Chilton, Ph.D., Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (Estimate)

June 16, 2010

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00007488
  • P50 AT 0027820 (Other Grant/Funding Number: NCCAM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on borage/echium oil combination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe