Chronic Kidney Diseases, Dialysis; Complications, Inflammation, Lipid Metabolism Disorders
Conditions
Keywords
Chronic kidney disease, hemodialysis, inflammation, dyslipidemia, flaxseed, pomagranate
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTflaxseed oil and pomegranate dry extract
The flaxseed oil were yellow capsules with 1.0 g each and the pomegranate dry extract capsules were green with 0.6 g each.
DIETARY_SUPPLEMENTsunflower oil and microcrystalline cellulose
The sunflower oil were yellow capsules with 1.0 g each and the microcrystalline cellulose capsules were green with 0.6 g each.
Sponsors
Santa Catarina Federal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 19 years; have a diagnosis of CKD; * perform HD three times a week for a period of ≥ three months; * acceptance of participation.
Exclusion criteria
* history of allergy to flaxseed or pomegranate; * infection or hospitalization in the beginning or during the course of the study; * HIV seropositivity and active malignancy; * pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor necrosis factor alpha | Change from Baseline and at 8 weeks (end of study) |
| interleukin 6 | Change from Baseline and at 8 weeks (end of study) |
| 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 10 | Change from Baseline and at 8 weeks (end of study) |
| C-reactive protein | Change from Baseline and at 8 weeks (end of study) |
| interferon-gamma | Change from Baseline and at 8 weeks (end of study) |
Secondary
| Measure | Time frame |
|---|---|
| high-density lipoprotein | Change from Baseline and at 8 weeks (end of study) |
| low-density lipoprotein | Change from Baseline and at 8 weeks (end of study) |
| triglycerides | Change from Baseline and at 8 weeks (end of study) |
| total cholesterol | Change from Baseline and at 8 weeks (end of study) |
Other
| Measure | Time frame |
|---|---|
| weight | Change from Baseline and at 8 weeks (end of study) |
| calf circumference | Change from Baseline and at 8 weeks (end of study) |
| waist circumference | Change from Baseline and at 8 weeks (end of study) |
| handgrip strength | Change from Baseline and at 8 weeks (end of study) |
| height | Change from Baseline and at 8 weeks (end of study) |
Countries
Brazil
Outcome results
None listed