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

Study Overview
=================
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.

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

Conditions
-----------------
Inflammation, Chronic Kidney Diseases, Dialysis; Complications, Lipid Metabolism Disorders

Intervention / Treatment
-----------------
* Dietary Supplement: flaxseed oil and pomegranate dry extract
* Dietary Supplement: sunflower oil and microcrystalline cellulose


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: flaxseed oil and pomegranate extract<br>2g daily of flaxseed oil plus 1.2g daily pomegranate dry extract | Dietary Supplement: flaxseed oil and pomegranate dry extract<br>* The flaxseed oil were yellow capsules with 1.0 g each and the pomegranate dry extract capsules were green with 0.6 g each.<br>|
| Placebo Comparator: sunflower oil and microcrystalline cellulose<br>2g daily of sunflower oil plus 1.2g daily microcrystalline cellulose | Dietary Supplement: sunflower oil and microcrystalline cellulose<br>* The sunflower oil were yellow capsules with 1.0 g each and the microcrystalline cellulose capsules were green with 0.6 g each.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease, hemodialysis, inflammation, dyslipidemia, flaxseed, pomagranate