Chronic Kidney DiseasesNCT05564676
Flaxseed Oil and Pomegranate Extract on Inflammation, Lipid Profile and Nutritional Status of Hemodialysis Patients
A study testing flaxseed oil and pomegranate dry extract and sunflower oil and microcrystalline cellulose in people with Chronic Kidney Diseases and Dialysis; Complications, run by Santa Catarina Federal University at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Dialysis; Complications, Inflammation
- What is being tested?
- flaxseed oil and pomegranate dry extract and sunflower oil and microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 19 years; have a diagnosis of CKD;
- perform HD three times a week for a period of ≥ three months;
- acceptance of participation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Santa Catarina
Florianópolis, Santa Catarina, 88040400
About this study
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
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.
- Conditions
- Chronic Kidney Diseases, Dialysis; Complications, Inflammation, Lipid Metabolism Disorders
- Being tested
- flaxseed oil and pomegranate dry extract, sunflower oil and microcrystalline cellulose
- Keywords
- Chronic kidney disease, hemodialysis, inflammation, dyslipidemia, flaxseed, pomagranate
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation, Lipid Metabolism Disorders, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flaxseed oil and pomegranate dry extractDietary supplement
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 celluloseDietary supplement
The sunflower oil were yellow capsules with 1.0 g each and the microcrystalline cellulose capsules were green with 0.6 g each.
| Study group | Role | What they receive |
|---|---|---|
| flaxseed oil and pomegranate extract | Experimental | 2g daily of flaxseed oil plus 1.2g daily pomegranate dry extract Receives: Dietary Supplement: flaxseed oil and pomegranate dry extract |
| sunflower oil and microcrystalline cellulose | Placebo comparator | 2g daily of sunflower oil plus 1.2g daily microcrystalline cellulose Receives: Dietary Supplement: sunflower oil and microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin 2
Measured: Change from Baseline and at 8 weeks (end of study)
interleukin 4
Measured: Change from Baseline and at 8 weeks (end of study)
interleukin 6
Measured: Change from Baseline and at 8 weeks (end of study)
interleukin 10
Measured: Change from Baseline and at 8 weeks (end of study)
tumor necrosis factor alpha
Measured: Change from Baseline and at 8 weeks (end of study)
interferon-gamma
Measured: Change from Baseline and at 8 weeks (end of study)
C-reactive protein
Measured: Change from Baseline and at 8 weeks (end of study)
Secondary outcomes (4)
total cholesterol
Measured: Change from Baseline and at 8 weeks (end of study)
high-density lipoprotein
Measured: Change from Baseline and at 8 weeks (end of study)
low-density lipoprotein
Measured: Change from Baseline and at 8 weeks (end of study)
triglycerides
Measured: Change from Baseline and at 8 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 May 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Catarina Federal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Miroski de Abreu, Santa Catarina Federal University
- Investigators
- Aline M de Abreu, MSc, Principal investigator, UFSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564676
- Sponsor's protocol ID
- UFSC
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05564676
- Acronym / sponsor ID
- UFSC
- Conditions
- Chronic Kidney Diseases, Dialysis; Complications, Inflammation, Lipid Metabolism Disorders
- Keywords
- Chronic kidney disease, hemodialysis, inflammation, dyslipidemia, flaxseed, pomagranate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Santa Catarina Federal UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flaxseed oil and pomegranate extract | Experimental | Dietary Supplement: flaxseed oil and pomegranate dry extract2g daily of flaxseed oil plus 1.2g daily pomegranate dry extract |
| sunflower oil and microcrystalline cellulose | Placebo comparator | Dietary Supplement: sunflower oil and microcrystalline cellulose2g daily of sunflower oil plus 1.2g daily microcrystalline cellulose |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 19 years; have a diagnosis of CKD;
- perform HD three times a week for a period of ≥ three months;
- acceptance of participation.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flaxseed oil and pomegranate dry extractThe flaxseed oil were yellow capsules with 1.0 g each and the pomegranate dry extract capsules were green with 0.6 g each. | Dietary supplement | flaxseed oil and pomegranate extract |
| sunflower oil and microcrystalline celluloseThe sunflower oil were yellow capsules with 1.0 g each and the microcrystalline cellulose capsules were green with 0.6 g each. | Dietary supplement | sunflower oil and microcrystalline cellulose |
Primary outcome
interleukin 2
Time frame: Change from Baseline and at 8 weeks (end of study)
interleukin 4
Time frame: Change from Baseline and at 8 weeks (end of study)
interleukin 6
Time frame: Change from Baseline and at 8 weeks (end of study)
interleukin 10
Time frame: Change from Baseline and at 8 weeks (end of study)
tumor necrosis factor alpha
Time frame: Change from Baseline and at 8 weeks (end of study)
interferon-gamma
Time frame: Change from Baseline and at 8 weeks (end of study)
C-reactive protein
Time frame: Change from Baseline and at 8 weeks (end of study)
4 secondary outcomes
total cholesterol
Time frame: Change from Baseline and at 8 weeks (end of study)
high-density lipoprotein
Time frame: Change from Baseline and at 8 weeks (end of study)
low-density lipoprotein
Time frame: Change from Baseline and at 8 weeks (end of study)
triglycerides
Time frame: Change from Baseline and at 8 weeks (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aline M de Abreu, MSc principal investigator
UFSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flaxseed oil and pomegranate dry extract and sunflower oil and microcrystalline cellulose in people with Chronic Kidney Diseases and Dialysis; Complications, run by Santa Catarina Federal University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interleukin 2 (time frame: Change from Baseline and at 8 weeks (end of study)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.