Flaxseed Oil and Pomegranate Extract on Inflammation, Lipid Profile and Nutritional Status of Hemodialysis Patients

Santa Catarina Federal University

Status: Completed

Conditions: Chronic Kidney Diseases; Inflammation; Lipid Metabolism Disorders; Dialysis; Complications

Treatments: Dietary Supplement: flaxseed oil and pomegranate dry extract; Dietary Supplement: sunflower oil and microcrystalline cellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT05564676

UFSC

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

flaxseed oil and pomegranate extract

Experimental group

Description:

2g daily of flaxseed oil plus 1.2g daily pomegranate dry extract

Treatment:

Dietary Supplement: flaxseed oil and pomegranate dry extract

sunflower oil and microcrystalline cellulose

Placebo Comparator group

Description:

2g daily of sunflower oil plus 1.2g daily microcrystalline cellulose

Treatment:

Dietary Supplement: sunflower oil and microcrystalline cellulose