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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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This is a single site, double-blind, randomized, crossover study designed to compare the effects of dietary supplementation with flax oil rich in alpha-linolenic acid (ALA) and fish oil rich in docosahexaenoic acid (DHA) on oxylipin profiles over time (0 to 4 weeks) and among obese females varying in their inflammatory state. Additional assessments will include plasma fatty acid composition, adipokines, markers of adipocyte dysfunction and inflammation; immune cell/monocyte fatty acid composition, and functional properties including their metabolism and oxylipin production; and vascular function.
A single site, double-blind, randomized, cross-over study designed to compare the effects of flax oil and fish oil supplementation on the oxylipin profile in females with obesity (n=24). Eligible participants will complete two supplementation phases (flax oil and fish oil rich in DHA) and will be asked to attend 3 in-person clinic visits (0, 3, and 28 days) for blood and urine collection during each phase. In addition to oxylipin profiles, assessments will include plasma fatty acid composition, adipokines, markers of adipocyte dysfunction and inflammation; immune cell/monocyte fatty acid composition, and functional properties including their metabolism and oxylipin production; and vascular function. If participants sign an optional consent form, vaginal fluid samples will be obtained at 0 and 28 days of each Supplementation Phase and analyzed for oxylipin and immune cell profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flax oil | Active Comparator | Participants will consume capsules containing flax oil (4 grams alpha-linolenic acid [ALA] per day) for 4 weeks |
|
| Fish oil | Active Comparator | Participants will consume capsules containing DHA-enriched fish oil (4 grams DHA per day + 0.8 grams EPA per day) for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsules containing flax oil | Dietary Supplement | Capsules containing flax oil to provide 4 grams ALA per day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma oxylipin concentrations over time | A fasting venous blood sample will be obtained from participants on Days 0, 3 and 28 of each Supplementation Phase for the assessment of plasma oxylipin profile. | Baseline, 3 days, 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma fatty acid composition over time | A fasting venous blood sample will be obtained from participants on Days 0, 3 and 28 of each Supplementation Phase for the assessment of plasma fatty acid composition. | Baseline, 3 days, 28 days |
| Monocyte metabolism over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla G Taylor, PhD | St Boniface Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.H. Asper Clinical Research Institute | Winnipeg | Manitoba | R2H 2A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34293124 | Derived | Pauls SD, Rodway LR, Sidhu KK, Winter T, Sidhu N, Aukema HM, Zahradka P, Taylor CG. Oils Rich in alpha-Linolenic Acid or Docosahexaenoic Acid Have Distinct Effects on Plasma Oxylipin and Adiponectin Concentrations and on Monocyte Bioenergetics in Women with Obesity. J Nutr. 2021 Oct 1;151(10):3053-3066. doi: 10.1093/jn/nxab235. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Obese females
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Double-blinded
| Capsules containing DHA-enriched fish oil | Dietary Supplement | Capsules containing fish oil to provide 4 grams DHA per day and 0.8 grams EPA per day for 4 weeks |
|
A fasting venous blood sample will be obtained from participants on Days 0 and 28 of each Supplementation Phase Changes for isolation of monocytes and assessment of their metabolic characteristics evaluated by Seahorse. |
| Baseline, 28 days |
| Monocyte fatty acid composition over time | A fasting venous blood sample will be obtained from participants on Days 0 and 28 of each Supplementation Phase for isolation of monocytes and assessment of their fatty acid composition. | Baseline, 28 days |
| Peripheral blood mononuclear cell (PBMC) oxylipin and cytokine production over time | A fasting venous blood sample will be obtained from participants on Days 0, 3, and 28 of each Supplementation Phase Changes for isolation of PBMCs and assessment of oxylipin and cytokine production ex vivo | Baseline, 3 days, 28 days |
| Plasma adiponectin concentrations over time | A fasting venous blood sample will be obtained from participants on Days 0, 3 and 28 of each Supplementation Phase for the assessment of plasma adiponectin, an anti-inflammatory adipokine and marker of adipocyte dysfunction. | Baseline, 3 days, 28 days |
| Vascular function changes over time | Assessment of of vascular function using pulse wave velocity determined at Day 0 and 28 of each Supplementation Phase. | Baseline, 28 days |
| Plasma lipid profile, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine over time | A fasting venous blood sample will be obtained from participants on Days 0, 3, and 28 of each Supplementation Phase for the assessment of plasma lipid profile, ALT, AST and creatinine | Baseline, 3 days, 28 days |
| Vaginal fluid oxylipin profile over time | If participants sign an optional consent form, vaginal fluid samples will be obtained at 0 and 28 days of each Supplementation Phase for assessment of the concentrations of oxylipins. | Baseline, 28 days |
| Vaginal fluid immune cell composition and function over time | If participants sign an optional consent form, vaginal fluid samples will be obtained at 0 and 28 days of each Supplementation Phase for characterization of immune cells by cell type and by functional assays for susceptibility to infection ex vivo. | Baseline, 28 days |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |