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

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

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 Overview

• Status: Completed
• Conditions: Inflammation; Chronic Kidney Diseases; Lipid Metabolism Disorders; Dialysis; Complications
• Intervention / Treatment: Dietary supplement: flaxseed oil and pomegranate dry extract; Dietary supplement: sunflower oil and microcrystalline cellulose

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil, 88040400
      • Federal University of Santa Catarina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: flaxseed oil and pomegranate extract; 2g daily of flaxseed oil plus 1.2g daily pomegranate dry extract	Dietary supplement: 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.
Placebo Comparator: sunflower oil and microcrystalline cellulose; 2g daily of sunflower oil plus 1.2g daily microcrystalline cellulose	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 6	Change from Baseline and at 8 weeks (end of study)
interleukin 10	Change from Baseline and at 8 weeks (end of study)
tumor necrosis factor alpha	Change from Baseline and at 8 weeks (end of study)
interferon-gamma	Change from Baseline and at 8 weeks (end of study)
C-reactive protein	Change from Baseline and at 8 weeks (end of study)

Secondary Outcome Measures

Outcome Measure	Time Frame
total cholesterol	Change from Baseline and at 8 weeks (end of study)
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)

Other Outcome Measures

Outcome Measure	Time Frame
weight	Change from Baseline and at 8 weeks (end of study)
height	Change from Baseline and at 8 weeks (end of study)
handgrip strength	Change from Baseline and at 8 weeks (end of study)
waist circumference	Change from Baseline and at 8 weeks (end of study)
calf circumference	Change from Baseline and at 8 weeks (end of study)

Collaborators and Investigators

• Sponsor: Santa Catarina Federal University
• Investigators: Principal Investigator: Aline M de Abreu, MSc, UFSC

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: inflammation; Chronic kidney disease; hemodialysis; flaxseed; dyslipidemia; pomagranate
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Inflammation; Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: UFSC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No