Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of especial diet therapy Anti-inflammatory Diet on inflammatory, oxidative stress, and nutritional markers in the context of protein-energy wasting syndrome(PEW) in hemodialysis patients.

Official Title
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Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients

Conditions
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Inflammation, Malnutrition, Protein Energy Wasting Syndrome, Oxidative Stress, Diet Therapy

Intervention / Treatment
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* Other: Diet Therapy
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are on hemodialysis(HD) at least two times a week for 3months or more without any internment illness or admission Exclusion Criteria: Hospitalization because of sepsis or surgery 3 months prior to intervention Cirrhosis Hepatitis virus infection Human Immunodeficiency virus infection Acquired Immunodeficiency Syndrome Active malignancy Active infection Absence of communication Mental Impairment Terminal illness Tube feedings Total parenteral nutrition Pregnancy Not previously seen by a dietitian within 3 months prior to enrollment in the study Not expected to be transplanted within 6 months after the enrollment in the study Absence of malnutrition from a cause other than end stage renal disease(ESRD) Psychiatric conditions, preventing adherence to intervention Consuming immunosuppressive drugs or taking antioxidant supplements including Vitamin E, Vitamin C, N-acetyl- cysteine (NAC), Pentoxifylline, Lipoic acid,Fish-oil extracts (omega-3 fatty acids), Soy extracts(isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts within 2 months prior to enrollment in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet therapy<br>The patients in this arm were educated to follow a especial type of diet (anti-inflammatory diet)in addition to nutrition counseling for 10 weeks. | Other: Diet Therapy<br>* The patients in this arm were educated to follow a especial type of diet (anti-inflammatory diet)in addition to nutrition counseling for 10 weeks.<br>|
| Other: Control Group<br>The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks. | Other: Control Group<br>* The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum Albumin |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subjective Global Assessment (SGA) score |  | 10 weeks | 
| Change in Malnutrition-inflammation score(MIS) |  | 10 weeks | 
| Change in serum C-Reactive Protein(CRP) |  | 10 weeks | 
| Change in serum malondialdehyde(MDA) |  | 10 weeks | 
| Change in serum Interleukin-6(IL-6) |  | 10 weeks | 
| Change in serum total antioxidant capacity(TAC) |  | 10 weeks | 
| Change in serum ferritin |  | 10 weeks | 
| Change in serum total iron binding capacity(TIBC) |  | 10 weeks | 
| Change in serum urea nitrogen |  | 10 weeks | 
| Change in serum creatinine |  | 10 weeks | 
| Change in serum phosphorus |  | 10 weeks | 
| Change in body fat mass index(BFMI) |  | 10 weeks | 
| Change in fat free mass index(FFMI) |  | 10 weeks | 
| Change in body cell mass(BCM) |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Diet, Inflammation, Malnutrition