Skip to main content
OpenTrials
Completed

NCT Number: NCT05564676

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Santa Catarina

Florianópolis, Santa Catarina, 88040400, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. interleukin 2

    Time frame: Change from Baseline and at 8 weeks (end of study)

  2. interleukin 4

    Time frame: Change from Baseline and at 8 weeks (end of study)

  3. interleukin 6

    Time frame: Change from Baseline and at 8 weeks (end of study)

  4. interleukin 10

    Time frame: Change from Baseline and at 8 weeks (end of study)

  5. tumor necrosis factor alpha

    Time frame: Change from Baseline and at 8 weeks (end of study)

  6. interferon-gamma

    Time frame: Change from Baseline and at 8 weeks (end of study)

  7. C-reactive protein

    Time frame: Change from Baseline and at 8 weeks (end of study)

Secondary outcomes

  1. total cholesterol

    Time frame: Change from Baseline and at 8 weeks (end of study)

  2. high-density lipoprotein

    Time frame: Change from Baseline and at 8 weeks (end of study)

  3. low-density lipoprotein

    Time frame: Change from Baseline and at 8 weeks (end of study)

  4. triglycerides

    Time frame: Change from Baseline and at 8 weeks (end of study)

Other outcomes

  1. weight

    Time frame: Change from Baseline and at 8 weeks (end of study)

  2. height

    Time frame: Change from Baseline and at 8 weeks (end of study)

  3. handgrip strength

    Time frame: Change from Baseline and at 8 weeks (end of study)

  4. waist circumference

    Time frame: Change from Baseline and at 8 weeks (end of study)

  5. calf circumference

    Time frame: Change from Baseline and at 8 weeks (end of study)

Sponsors and collaborators

Lead sponsor

Santa Catarina Federal University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2022
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.