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Completed

NCT Number: NCT01145066

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

borage/echium oil combination

Drug

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

Fish Oil

Dietary Supplement

1.6g/day EPA and 1.08g/day DHA

Other names: Croda 18:12 fish oil

corn oil

Dietary Supplement

contains 4.5 g/day linoleic acid

Other names: Croda superrefined corn NF

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 16, 2010
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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