Flaxseed Oil and Pomegranate Extract on Inflammation, Lipid Profile and Nutritional Status of Hemodialysis Patients
NCT ID: NCT05564676
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2021-05-01
2021-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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flaxseed oil and pomegranate extract
2g daily of flaxseed oil plus 1.2g daily pomegranate dry extract
flaxseed 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.
sunflower oil and microcrystalline cellulose
2g daily of sunflower oil plus 1.2g daily microcrystalline cellulose
sunflower 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.
Interventions
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flaxseed 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.
sunflower 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.
Eligibility Criteria
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Inclusion Criteria
* perform HD three times a week for a period of ≥ three months;
* acceptance of participation.
Exclusion Criteria
* infection or hospitalization in the beginning or during the course of the study;
* HIV seropositivity and active malignancy;
* pregnancy or breastfeeding.
19 Years
ALL
No
Sponsors
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Santa Catarina Federal University
OTHER
Responsible Party
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Aline Miroski de Abreu
Principal investigator
Principal Investigators
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Aline M de Abreu, MSc
Role: PRINCIPAL_INVESTIGATOR
UFSC
Locations
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Federal University of Santa Catarina
Florianópolis, Santa Catarina, Brazil
Countries
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Other Identifiers
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UFSC
Identifier Type: -
Identifier Source: org_study_id
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