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

Not Applicable

Completed

• Conditions: Diet Therapy; Inflammation; Malnutrition; Protein Energy Wasting Syndrome; Oxidative Stress

• Registration Number: NCT01874106
• Lead Sponsor: Maryam Ekramzadeh, PhD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-04
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-10
• Study Completion: 2013-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in serum Albumin	10 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shiraz University of Medical Sciences, Department of Nutrition; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of