Clinical trial NCT05564676: Flaxseed Oil and Pomegranate Extract on Inflammation, Lipid Profile and Nutritional Status of Hemodialysis Patients
Official title: Effects of Supplementation With Flaxseed Oil and Pomegranate Extract on Inflammation Markers, Lipid Profile and Nutritional Status of Individuals on Hemodialysis: a Randomized, Placebo-controlled, Triple-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Dialysis; Complications
Inflammation
Lipid Metabolism Disorders
Keywords: Chronic kidney disease
hemodialysis
inflammation
dyslipidemia
flaxseed
pomagranate
Lead sponsor: Santa Catarina Federal University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: interleukin 2
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: interleukin 4
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: interleukin 6
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: interleukin 10
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: tumor necrosis factor alpha
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: interferon-gamma
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: C-reactive protein
timeFrame: Change from Baseline and at 8 weeks (end of study)
Secondary outcomes:
measure: total cholesterol
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: high-density lipoprotein
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: low-density lipoprotein
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: triglycerides
timeFrame: Change from Baseline and at 8 weeks (end of study)
Other outcomes:
measure: weight
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: height
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: handgrip strength
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: waist circumference
timeFrame: Change from Baseline and at 8 weeks (end of study)
measure: calf circumference
timeFrame: Change from Baseline and at 8 weeks (end of study)
Locations:
city: Florianópolis
country: Brazil
facility: Federal University of Santa Catarina
state: Santa Catarina
Study officials:
affiliation: UFSC
name: Aline M de Abreu, MSc
role: PRINCIPAL_INVESTIGATOR
References: