DiabetesPhase 2NCT01145066

Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

A Phase 2 study testing borage/echium oil combination, fish oil and corn oil in people with Diabetes and Metabolic Syndrome x, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Diabetes, Metabolic Syndrome x
What is being tested?: borage/echium oil combination, fish oil and corn oil
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteUnited States
Study dates: May 2009to Mar 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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%

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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.

Conditions: Diabetes, Metabolic Syndrome x
Being tested: borage/echium oil combination, fish oil, corn oil
Keywords: diabetes, metabolic syndrome, inflammation, botanical oils
Medical subject headings: Diabetes Mellitus, Metabolic Syndrome, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

borage/echium oil combinationDrug
Also called Croda echium oil SR06379, Croda borage oil, Crossential GLA TG40
borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA
fish oilDietary supplement
Also called Croda 18:12 fish oil
1.6g/day EPA and 1.08g/day DHA
corn oilDietary supplement
Also called Croda superrefined corn NF
contains 4.5 g/day linoleic acid

Study groups in NCT01145066
Study group	Role	What they receive
borage and echium oil combination	Experimental	borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA Receives: Drug: borage/echium oil combination
fish oil	Active comparator	Croda 18:12 fish oil Receives: Dietary Supplement: fish oil
corn oil	Placebo comparator	Not described Receives: Dietary Supplement: corn oil

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (15)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Mar 2011

First posted16 Jun 2010 (estimated)
Study startMay 2009
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01145066
Sponsor's protocol ID: IRB00007488
Other IDs: P50 AT 0027820
Status last verified: Dec 2018
First submitted: 14 Jun 2010
Last updated: 18 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 25515553

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modulation of Biomarkers and Gene Expression by Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects.
ClinicalTrials.gov ID: NCT01145066
Acronym / sponsor ID: IRB00007488
Conditions: Diabetes, Metabolic Syndrome x
Keywords: diabetes, metabolic syndrome, inflammation, botanical oils
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: Brigham and Women's Hospital
Study start: May 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 16 Jun 2010 (estimated)
Results: Posted 26 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
borage and echium oil combination	Experimental	Drug: borage/echium oil combinationborage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA
fish oil	Active comparator	Dietary Supplement: fish oilCroda 18:12 fish oil
corn oil	Placebo comparator	Dietary Supplement: corn oil

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
borage/echium oil combinationAlso: Croda echium oil SR06379, Croda borage oil, Crossential GLA TG40borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Drug	borage and echium oil combination
fish oilAlso: Croda 18:12 fish oil1.6g/day EPA and 1.08g/day DHA	Dietary supplement	fish oil
corn oilAlso: Croda superrefined corn NFcontains 4.5 g/day linoleic acid	Dietary supplement	corn oil

Primary outcome

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

15 secondary outcomes

Serum Fatty Acids
Time frame: baseline
Serum Fatty Acids
Time frame: 4 weeks and 8 weeks combined
Pro and Anti-inflammatory Cytokines
Time frame: baseline
Pro and Anti-inflammatory Cytokines
Time frame: 4 weeks and 8 weeks combined
Fasting Glucose
Time frame: baseline
Fasting Glucose
Time frame: 4 weeks and 8 weeks combined
Hemoglobin Levels
Time frame: baseline
Hemoglobin Levels
Time frame: 4 weeks and 8 weeks combined
Adipose Derived Cytokines
Time frame: 4 weeks
PBMC Gene Expression
Time frame: baseline
PBMC Gene Expression
Time frame: 4 weeks
SNPs in DNA of Selected Genes
Time frame: baseline
SNPs in DNA of Selected Genes
Time frame: 4 weeks
PBMC Leukotriene Stimulation
Time frame: baseline
PBMC Leukotriene Stimulation
Time frame: 4 weeks

Results and safety

Results posted to the registry on 26 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Borage and Echium Oil Combination	26	22
Fish Oil	20	16
Corn Oil	25	21

Primary outcome: Fasting Insulin

Time frame: baseline. Mean (Standard Deviation). Unit: μIU/mL

Measure	Borage and Echium Oil Combination n = 22	Fish Oil n = 16	Corn Oil n = 21
Value	15.4 (2.0)	19.1 (4.5)	20.2 (3.2)

Primary outcome: Fasting Insulin

Time frame: 4 weeks and 8 weeks combined. Mean (Standard Deviation). Unit: μIU/mL

Measure	Borage and Echium Oil Combination n = 22	Fish Oil n = 16	Corn Oil n = 21
Value	17.7 (2.6)	24.6 (6.8)	20.6 (3.3)

Primary outcome: hsCRP

Time frame: baseline. Mean (Standard Deviation). Unit: mg/L

Measure	Borage and Echium Oil Combination n = 22	Fish Oil n = 16	Corn Oil n = 21
Value	3.03 (.85)	6.08 (3.19)	2.36 (.57)

Primary outcome: hsCRP

Time frame: 4 weeks and 8 weeks combined. Mean (Standard Deviation). Unit: mg/L

Measure	Borage and Echium Oil Combination n = 22	Fish Oil n = 16	Corn Oil n = 21
Value	3.06 (.86)	3.59 (1.03)	3.72 (1.00)

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 8 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Borage and Echium Oil Combination	0 of 26 (0%)	4 of 26 (15.4%)	0 of 26
Fish Oil	0 of 20 (0%)	5 of 20 (25%)	0 of 20
Corn Oil	0 of 25 (0%)	6 of 25 (24%)	0 of 25

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25515553Lee 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.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Floyd(Ski) H Chilton, Ph.D. principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Insulin (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01145066, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.