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

NCT05564676 | Completed

• 1 other identifier: UFSC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chronic kidney disease; hemodialysis; inflammation; dyslipidemia; flaxseed; pomagranate

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• 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 Outcomes (5)

• 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)

Study Arms (2)

flaxseed oil and pomegranate extract

EXPERIMENTAL

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

Dietary Supplement: flaxseed oil and pomegranate dry extract

sunflower oil and microcrystalline cellulose

PLACEBO COMPARATOR

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

Dietary Supplement: sunflower oil and microcrystalline cellulose

Interventions

flaxseed oil and pomegranate dry extract DIETARY_SUPPLEMENT

The flaxseed oil were yellow capsules with 1.0 g each and the pomegranate dry extract capsules were green with 0.6 g each.

flaxseed oil and pomegranate extract

sunflower oil and microcrystalline cellulose DIETARY_SUPPLEMENT

The sunflower oil were yellow capsules with 1.0 g each and the microcrystalline cellulose capsules were green with 0.6 g each.

sunflower oil and microcrystalline cellulose

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 19 years; have a diagnosis of CKD;
• perform HD three times a week for a period of ≥ three months;
• acceptance of participation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santa Catarina Federal University: lead

Study Sites (1)

Federal University of Santa Catarina

Florianópolis, Santa Catarina, 88040400, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation; Lipid Metabolism Disorders; Dyslipidemias

Interventions

Linseed Oil; Sunflower Oil; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Aline M de Abreu, MSc

  UFSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: October 3, 2022
• Study Start: May 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: October 4, 2022

Record last verified: 2022-09

Locations

BR (1)