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

Primary Purpose

Chronic Kidney Diseases, Dialysis; Complications, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
flaxseed oil and pomegranate dry extract
sunflower oil and microcrystalline cellulose
Sponsored by
Santa Catarina Federal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Diseases focused on measuring Chronic kidney disease, hemodialysis, inflammation, dyslipidemia, flaxseed, pomagranate

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Federal University of Santa Catarina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

flaxseed oil and pomegranate extract

sunflower oil and microcrystalline cellulose

Arm Description

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

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

Outcomes

Primary Outcome Measures

interleukin 2
interleukin 4
interleukin 6
interleukin 10
tumor necrosis factor alpha
interferon-gamma
C-reactive protein

Secondary Outcome Measures

total cholesterol
high-density lipoprotein
low-density lipoprotein
triglycerides

Full Information

First Posted
September 4, 2022
Last Updated
September 30, 2022
Sponsor
Santa Catarina Federal University
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1. Study Identification

Unique Protocol Identification Number
NCT05564676
Brief Title
Flaxseed Oil and Pomegranate Extract on Inflammation, Lipid Profile and Nutritional Status of Hemodialysis Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Santa Catarina Federal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Dialysis; Complications, Inflammation, Lipid Metabolism Disorders
Keywords
Chronic kidney disease, hemodialysis, inflammation, dyslipidemia, flaxseed, pomagranate

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flaxseed oil and pomegranate extract
Arm Type
Experimental
Arm Description
2g daily of flaxseed oil plus 1.2g daily pomegranate dry extract
Arm Title
sunflower oil and microcrystalline cellulose
Arm Type
Placebo Comparator
Arm Description
2g daily of sunflower oil plus 1.2g daily microcrystalline cellulose
Intervention Type
Dietary Supplement
Intervention Name(s)
flaxseed oil and pomegranate dry extract
Intervention Description
The flaxseed oil were yellow capsules with 1.0 g each and the pomegranate dry extract capsules were green with 0.6 g each.
Intervention Type
Dietary Supplement
Intervention Name(s)
sunflower oil and microcrystalline cellulose
Intervention Description
The sunflower oil were yellow capsules with 1.0 g each and the microcrystalline cellulose capsules were green with 0.6 g each.
Primary Outcome Measure Information:
Title
interleukin 2
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
interleukin 4
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
interleukin 6
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
interleukin 10
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
tumor necrosis factor alpha
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
interferon-gamma
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
C-reactive protein
Time Frame
Change from Baseline and at 8 weeks (end of study)
Secondary Outcome Measure Information:
Title
total cholesterol
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
high-density lipoprotein
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
low-density lipoprotein
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
triglycerides
Time Frame
Change from Baseline and at 8 weeks (end of study)
Other Pre-specified Outcome Measures:
Title
weight
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
height
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
handgrip strength
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
waist circumference
Time Frame
Change from Baseline and at 8 weeks (end of study)
Title
calf circumference
Time Frame
Change from Baseline and at 8 weeks (end of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline M de Abreu, MSc
Organizational Affiliation
UFSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Santa Catarina
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88040400
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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