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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05564676
Other study ID # UFSC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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)
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