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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
50
The flaxseed oil were yellow capsules with 1.0 g each and the pomegranate dry extract capsules were green with 0.6 g each.
The sunflower oil were yellow capsules with 1.0 g each and the microcrystalline cellulose capsules were green with 0.6 g each.
Federal University of Santa Catarina
Florianópolis, Santa Catarina, Brazil
interleukin 2
Time frame: Change from Baseline and at 8 weeks (end of study)
interleukin 4
Time frame: Change from Baseline and at 8 weeks (end of study)
interleukin 6
Time frame: Change from Baseline and at 8 weeks (end of study)
interleukin 10
Time frame: Change from Baseline and at 8 weeks (end of study)
tumor necrosis factor alpha
Time frame: Change from Baseline and at 8 weeks (end of study)
interferon-gamma
Time frame: Change from Baseline and at 8 weeks (end of study)
C-reactive protein
Time frame: Change from Baseline and at 8 weeks (end of study)
total cholesterol
Time frame: Change from Baseline and at 8 weeks (end of study)
high-density lipoprotein
Time frame: Change from Baseline and at 8 weeks (end of study)
low-density lipoprotein
Time frame: Change from Baseline and at 8 weeks (end of study)
triglycerides
Time frame: Change from Baseline and at 8 weeks (end of study)
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