Diet Therapy, Inflammation, Malnutrition, Oxidative Stress, Protein Energy Wasting Syndrome
Conditions
Keywords
Hemodialysis, Diet, Inflammation, Malnutrition
Brief summary
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.
Interventions
OTHERDiet Therapy
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.
OTHERControl Group
The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks.
Sponsors
Shiraz University of Medical Sciences
Maryam Ekramzadeh, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum Albumin | 10 weeks |
Secondary
| Measure | 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 |
Countries
Iran
Outcome results
None listed