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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05564676
• Other study ID #: UFSC
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2022
• Source: Santa Catarina Federal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Dialysis; Complications
• Inflammation
• Kidney Diseases
• Lipid Metabolism Disorders
• Metabolic Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Santa Catarina	Florianópolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Santa Catarina Federal University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	weight		Change from Baseline and at 8 weeks (end of study)
Other	height		Change from Baseline and at 8 weeks (end of study)
Other	handgrip strength		Change from Baseline and at 8 weeks (end of study)
Other	waist circumference		Change from Baseline and at 8 weeks (end of study)
Other	calf circumference		Change from Baseline and at 8 weeks (end of study)
Primary	interleukin 2		Change from Baseline and at 8 weeks (end of study)
Primary	interleukin 4		Change from Baseline and at 8 weeks (end of study)
Primary	interleukin 6		Change from Baseline and at 8 weeks (end of study)
Primary	interleukin 10		Change from Baseline and at 8 weeks (end of study)
Primary	tumor necrosis factor alpha		Change from Baseline and at 8 weeks (end of study)
Primary	interferon-gamma		Change from Baseline and at 8 weeks (end of study)
Primary	C-reactive protein		Change from Baseline and at 8 weeks (end of study)
Secondary	total cholesterol		Change from Baseline and at 8 weeks (end of study)
Secondary	high-density lipoprotein		Change from Baseline and at 8 weeks (end of study)
Secondary	low-density lipoprotein		Change from Baseline and at 8 weeks (end of study)
Secondary	triglycerides		Change from Baseline and at 8 weeks (end of study)