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Nutritional and metabolic alterations in patients with chronic kidney disease (CKD) such as inflammation, oxidative stress, dyslipidemia, and poor nutritional status which associate with poor clinical outcome can potentially be targeted and ameliorated by interventions using nutritional supplements. The investigators evaluated the effects of 8 weeks of oral supplementation with flaxseed oil and pomegranate dry extract on markers of inflammation, lipid profile and nutritional status of individuals undergoing hemodialysis (HD).
The goal of this randomized, placebo-controlled, double-blind clinical trial is to evaluate the effects of 8 weeks of oral supplementation with flaxseed oil and pomegranate dry extract on markers of inflammation, lipid profile and nutritional status of individuals undergoing hemodialysis (HD).
Participants will be randomly assigned, in a 1:1 ratio, to supplementation group to receive twice a day 1 capsule of 1.000 mg of flaxseed oil plus 1 capsule of 600mg of pomegranate dry extract; or to placebo group, to receive twice a day 1 capsule of 1.000 mg of sunflower oil plus 1 capsule of 600mg of microcrystalline celulose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flaxseed oil and pomegranate extract | Experimental | 2g daily of flaxseed oil plus 1.2g daily pomegranate dry extract |
|
| sunflower oil and microcrystalline cellulose | Placebo Comparator | 2g daily of sunflower oil plus 1.2g daily microcrystalline cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flaxseed oil and pomegranate dry extract | Dietary Supplement | The flaxseed oil were yellow capsules with 1.0 g each and the pomegranate dry extract capsules were green with 0.6 g each. |
| Measure | Description | Time Frame |
|---|---|---|
| interleukin 2 | Change from Baseline and at 8 weeks (end of study) | |
| interleukin 4 | Change from Baseline and at 8 weeks (end of study) | |
| interleukin 6 | Change from Baseline and at 8 weeks (end of study) | |
| interleukin 10 | Change from Baseline and at 8 weeks (end of study) | |
| tumor necrosis factor alpha | Change from Baseline and at 8 weeks (end of study) | |
| interferon-gamma | Change from Baseline and at 8 weeks (end of study) | |
| C-reactive protein | Change from Baseline and at 8 weeks (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| total cholesterol | Change from Baseline and at 8 weeks (end of study) | |
| high-density lipoprotein | Change from Baseline and at 8 weeks (end of study) | |
| low-density lipoprotein |
| Measure | Description | Time Frame |
|---|---|---|
| weight | Change from Baseline and at 8 weeks (end of study) | |
| height | Change from Baseline and at 8 weeks (end of study) | |
| handgrip strength |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aline M de Abreu, MSc | UFSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Santa Catarina | Florianópolis | Santa Catarina | 88040400 | Brazil |
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| sunflower oil and microcrystalline cellulose | Dietary Supplement | The sunflower oil were yellow capsules with 1.0 g each and the microcrystalline cellulose capsules were green with 0.6 g each. |
|
| Change from Baseline and at 8 weeks (end of study) |
| triglycerides | Change from Baseline and at 8 weeks (end of study) |
| Change from Baseline and at 8 weeks (end of study) |
| waist circumference | Change from Baseline and at 8 weeks (end of study) |
| calf circumference | Change from Baseline and at 8 weeks (end of study) |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007249 | Inflammation |
| D052439 | Lipid Metabolism Disorders |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008043 | Linseed Oil |
| D000074242 | Sunflower Oil |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D005224 | Fats, Unsaturated |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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