Clinical trial NCT01874106: Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
Official title: Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Malnutrition
Protein Energy Wasting Syndrome
Oxidative Stress
Diet Therapy
Keywords: Hemodialysis
Diet
Inflammation
Malnutrition
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shiraz University of Medical Sciences
First posted: 2013-06-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in serum Albumin
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in Subjective Global Assessment (SGA) score
timeFrame: 10 weeks
measure: Change in Malnutrition-inflammation score(MIS)
timeFrame: 10 weeks
measure: Change in serum C-Reactive Protein(CRP)
timeFrame: 10 weeks
measure: Change in serum malondialdehyde(MDA)
timeFrame: 10 weeks
measure: Change in serum Interleukin-6(IL-6)
timeFrame: 10 weeks
measure: Change in serum total antioxidant capacity(TAC)
timeFrame: 10 weeks
measure: Change in serum ferritin
timeFrame: 10 weeks
measure: Change in serum total iron binding capacity(TIBC)
timeFrame: 10 weeks
measure: Change in serum urea nitrogen
timeFrame: 10 weeks
measure: Change in serum creatinine
timeFrame: 10 weeks
measure: Change in serum phosphorus
timeFrame: 10 weeks
measure: Change in body fat mass index(BFMI)
timeFrame: 10 weeks
measure: Change in fat free mass index(FFMI)
timeFrame: 10 weeks
measure: Change in body cell mass(BCM)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences, Department of Nutrition
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences, Faculty of Nutrition
name: Zohreh Mazloom, PhD
role: STUDY_DIRECTOR
affiliation: Shiraz University of Medical Sciences, Nephrology Urology Research Center
name: Mohammadmahdi Sagheb, MD
role: STUDY_CHAIR
References: