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

Sponsor

Santa Catarina Federal University (Other)

Overall Status

Completed

CT.gov ID

NCT05564676

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

16.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Dialysis; Complications Inflammation Lipid Metabolism Disorders	Dietary Supplement: flaxseed oil and pomegranate dry extract Dietary Supplement: sunflower oil and microcrystalline cellulose	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Jul 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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.