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| ID | Type | Description | Link |
|---|---|---|---|
| P50 AT 0027820 | Other Grant/Funding Number | NCCAM |
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| borage and echium oil combination | Experimental | borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA |
|
| fish oil | Active Comparator | Croda 18:12 fish oil |
|
| corn oil | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| borage/echium oil combination | Drug | borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Fatty Acids | baseline | |
| Serum Fatty Acids | Data at 4 and 8 weeks was averaged. | 4 weeks and 8 weeks combined |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Floyd(Ski) H Chilton, Ph.D. | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25515553 | Derived | 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. |
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80 participants signed consent, only 71 were randomized to an arm/group
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| ID | Title | Description |
|---|---|---|
| FG000 | Borage and Echium Oil Combination | borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA |
| FG001 | Fish Oil | Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA |
| FG002 | Corn Oil | corn oil: contains 4.5 g/day linoleic acid |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Borage and Echium Oil Combination | borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA |
| BG001 | Fish Oil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fasting Insulin | Posted | Mean | Standard Deviation | μIU/mL | baseline |
|
up to 8 weeks
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Borage and Echium Oil Combination | borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sick/virus | Immune system disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Seeds | Wake Forest University Health Sciences | 3367169811 | mseeds@wakehealth.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D024821 | Metabolic Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| C051440 | lanpol 5 |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
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| fish oil | Dietary Supplement | 1.6g/day EPA and 1.08g/day DHA |
|
|
| corn oil | Dietary Supplement | contains 4.5 g/day linoleic acid |
|
|
| Pro and Anti-inflammatory Cytokines |
| baseline |
| Pro and Anti-inflammatory Cytokines | 4 weeks and 8 weeks combined |
| Fasting Glucose | baseline |
| Fasting Glucose | Data at 4 and 8 weeks was averaged. | 4 weeks and 8 weeks combined |
| Hemoglobin Levels | baseline |
| Hemoglobin Levels | Data at 4 and 8 weeks was averaged. | 4 weeks and 8 weeks combined |
| Adipose Derived Cytokines | 4 weeks |
| PBMC Gene Expression | baseline |
| PBMC Gene Expression | 4 weeks |
| SNPs in DNA of Selected Genes | baseline |
| SNPs in DNA of Selected Genes | 4 weeks |
| PBMC Leukotriene Stimulation | baseline |
| PBMC Leukotriene Stimulation | 4 weeks |
| Withdrawal by Subject |
|
| To start new med |
|
| problems swallowing capsule |
|
| Abdominal discomfort |
|
| Low platelet count |
|
Croda 18:12 fish oil
fish oil: 1.6g/day EPA and 1.08g/day DHA
| BG002 | Corn Oil | corn oil: contains 4.5 g/day linoleic acid |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Fasting Insulin | Fasting insulin data at 4 and 8 weeks was averaged. | Posted | Mean | Standard Deviation | μIU/mL | 4 weeks and 8 weeks combined |
|
|
|
| Primary | hsCRP | Changes in high sensitive C-reactive protein (hsCRP) were assessed. | Posted | Mean | Standard Deviation | mg/L | baseline |
|
|
|
| Primary | hsCRP | Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged.. | Posted | Mean | Standard Deviation | mg/L | 4 weeks and 8 weeks combined |
|
|
|
| Primary | Leptin | Posted | Mean | Standard Deviation | ng/mL | baseline |
|
|
|
| Primary | Leptin | Data at 4 and 8 weeks was averaged. | Posted | Mean | Standard Deviation | ng/mL | 4 weeks and 8 weeks combined |
|
|
|
| Secondary | Serum Fatty Acids | Posted | Mean | Standard Deviation | percentage of total fatty acids | baseline |
|
|
|
| Secondary | Serum Fatty Acids | Data at 4 and 8 weeks was averaged. | Posted | Mean | Standard Deviation | percentage of total fatty acids | 4 weeks and 8 weeks combined |
|
|
|
| Secondary | Pro and Anti-inflammatory Cytokines | No data collected | Posted | baseline |
|
|
| Secondary | Pro and Anti-inflammatory Cytokines | No data collected | Posted | 4 weeks and 8 weeks combined |
|
|
| Secondary | Fasting Glucose | Posted | Mean | Standard Deviation | mg/dL | baseline |
|
|
|
| Secondary | Fasting Glucose | Data at 4 and 8 weeks was averaged. | Posted | Mean | Standard Deviation | mg/dL | 4 weeks and 8 weeks combined |
|
|
|
| Secondary | Hemoglobin Levels | Posted | Mean | Standard Deviation | mg/dL | baseline |
|
|
|
| Secondary | Hemoglobin Levels | Data at 4 and 8 weeks was averaged. | Posted | Mean | Standard Deviation | mg/dL | 4 weeks and 8 weeks combined |
|
|
|
| Secondary | Adipose Derived Cytokines | No data collected | Posted | 4 weeks |
|
|
| Secondary | PBMC Gene Expression | No data collected | Posted | baseline |
|
|
| Secondary | PBMC Gene Expression | No data collected | Posted | 4 weeks |
|
|
| Secondary | SNPs in DNA of Selected Genes | No data collected | Posted | baseline |
|
|
| Secondary | SNPs in DNA of Selected Genes | No data collected | Posted | 4 weeks |
|
|
| Secondary | PBMC Leukotriene Stimulation | No data collected | Posted | baseline |
|
|
| Secondary | PBMC Leukotriene Stimulation | No data collected | Posted | 4 weeks |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 4 |
| 26 |
| EG001 | Fish Oil | Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA | 0 | 20 | 0 | 20 | 5 | 20 |
| EG002 | Corn Oil | corn oil: contains 4.5 g/day linoleic acid | 0 | 25 | 0 | 25 | 6 | 25 |
| GI Upset | Gastrointestinal disorders | Non-systematic Assessment | Bloating/constipation |
|
| GI Upset | Gastrointestinal disorders | Non-systematic Assessment | burping/diarrhea/loose stools |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Weak | Metabolism and nutrition disorders | Non-systematic Assessment | blood sugar varied 1 day or more |
|
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| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005223 |
| Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
|
| C15:0 |
|
| C15:1 |
|
| C16:0 |
|
| C16:1 n-7 |
|
| C17:1 |
|
| C18:0 |
|
| C18:1 |
|
| C18:1 n-9 |
|
| C18:1 n-11 |
|
| C18:2 n-6 [LA] |
|
| C18:3 n-6 [GLA] |
|
| C18:3 n-3 [ALA] |
|
| C18:4 n-3 [SDA] |
|
| C20:0 |
|
| C20:1 n-9 |
|
| C20:2 n-6 |
|
| C20:3 n-6 [DGLA] |
|
| C20:4 n-6 [AA] |
|
| C20:5 n-3 [EPA] |
|
| C22:0 |
|
| C22:1 n-9 |
|
| C22:2 n-6 |
|
| C22:5 n-3 [DPA] |
|
| C24:0 |
|
| C22:6 n-3 [DHA] |
|
| C24:1 n-9 |
|
|
| C15:0 |
|
| C15:1 |
|
| C16:0 |
|
| C16:1 n-7 |
|
| C17:1 |
|
| C18:0 |
|
| C18:1 |
|
| C18:1 n-9 |
|
| C18:1 n-11 |
|
| C18:2 n-6 [LA] |
|
| C18:3 n-6 [GLA] |
|
| C18:3 n-3 [ALA] |
|
| C18:4 n-3 [SDA] |
|
| C20:0 |
|
| C20:1 n-9 |
|
| C20:2 n-6 |
|
| C20:3 n-6 [DGLA] |
|
| C20:4 n-6 [AA] |
|
| C20:5 n-3 [EPA] |
|
| C22:0 |
|
| C22:1 n-9 |
|
| C22:2 n-6 |
|
| C22:5 n-3 [DPA] |
|
| C24:0 |
|
| C22:6 n-3 [DHA] |
|
| C24:1 n-9 |
|