Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Botanical Oils Study to Determine Genetic Differences in the Way Your Body Processes Fats in Edible Oils

NCT02337231

Genetic Differences of Lipid Metabolism/Healthy Subjects

COMPLETED NA

Nuts and Oil Pilot Study

NCT04361617

Metabolic Syndrome

COMPLETED NA

Effects of Walnuts on Endothelial Function in Overweight Adults With at Least One Factor of Metabolic Syndrome

NCT01413646

Metabolic Syndrome

COMPLETED NA

Butyrate/Hexanoate in Metabolic Health

NCT04662411

Metabolic Disease

COMPLETED NA

Blended Oil Beneficial for Blood Lipids Management

NCT03964857

Hyperlipidemias

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Metabolic Syndrome x

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

borage and echium oil combination

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

Group Type EXPERIMENTAL

borage/echium oil combination

Intervention Type DRUG

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

fish oil

Croda 18:12 fish oil

Group Type ACTIVE_COMPARATOR

fish oil

Intervention Type DIETARY_SUPPLEMENT

1.6g/day EPA and 1.08g/day DHA

corn oil

Group Type PLACEBO_COMPARATOR

corn oil

Intervention Type DIETARY_SUPPLEMENT

contains 4.5 g/day linoleic acid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

borage/echium oil combination

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

Intervention Type DRUG

fish oil

1.6g/day EPA and 1.08g/day DHA

Intervention Type DIETARY_SUPPLEMENT

corn oil

contains 4.5 g/day linoleic acid

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Croda echium oil SR06379 Croda borage oil, Crossential GLA TG40 Croda 18:12 fish oil Croda superrefined corn NF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No