Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

NCT01145066 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB00007488P50 AT 0027820
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Metabolic Syndrome x

Keywords

diabetes; metabolic syndrome; inflammation; botanical oils

Outcome Measures

Primary Outcomes (6)

• Fasting Insulin

  baseline

• Fasting Insulin

  Fasting insulin data at 4 and 8 weeks was averaged.

  4 weeks and 8 weeks combined

• hsCRP

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

  baseline

• hsCRP

  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

  baseline

• Leptin

  Data at 4 and 8 weeks was averaged.

  4 weeks and 8 weeks combined

Secondary Outcomes (15)

• Serum Fatty Acids

  baseline

• Serum Fatty Acids

  4 weeks and 8 weeks combined

• Pro and Anti-inflammatory Cytokines

  baseline

• Pro and Anti-inflammatory Cytokines

  4 weeks and 8 weeks combined

• Fasting Glucose

  baseline

Study Arms (3)

borage and echium oil combination

EXPERIMENTAL

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

Drug: borage/echium oil combination

fish oil

ACTIVE COMPARATOR

Croda 18:12 fish oil

Dietary Supplement: fish oil

corn oil

PLACEBO COMPARATOR

Dietary Supplement: corn oil

Interventions

borage/echium oil combination DRUG

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

Also known as: Croda echium oil SR06379, Croda borage oil, Crossential GLA TG40

borage and echium oil combination

fish oil DIETARY_SUPPLEMENT

1.6g/day EPA and 1.08g/day DHA

Also known as: Croda 18:12 fish oil

fish oil

corn oil DIETARY_SUPPLEMENT

contains 4.5 g/day linoleic acid

Also known as: Croda superrefined corn NF

corn oil

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 25515553 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Metabolic Syndrome; Inflammation

Interventions

Fish Oils; lanpol 5; Corn Oil

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

The diet study was short at only 8 weeks of oil supplementation, it did not control background PUFA consumption by the subjects throught their normal diets, and the population contained subjects at various stages of T2D.

Results Point of Contact

• Title: Dr. Michael Seeds
• Organization: Wake Forest University Health Sciences

mseeds@wakehealth.edu

3367169811

Study Officials

• Floyd(Ski) H Chilton, Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: May 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 18, 2019
• Results First Posted: December 26, 2018

Record last verified: 2018-12

Locations

US (1)