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
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 |
Verified date | September 2022 |
Source | Santa Catarina Federal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Santa Catarina | Florianópolis | Santa Catarina |
Lead Sponsor | Collaborator |
---|---|
Santa Catarina Federal University |
Brazil,
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03995979 -
Inflammation and Protein Restriction
|
N/A | |
Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
Completed |
NCT05529693 -
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
|
N/A | |
Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
Recruiting |
NCT05775731 -
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
|
||
Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
Completed |
NCT06065241 -
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
|
N/A | |
Completed |
NCT05864352 -
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
|
||
Completed |
NCT03318731 -
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
|
N/A | |
Not yet recruiting |
NCT06134076 -
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
|
N/A | |
Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A |