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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Malnutrition; Oxidative Stress; Diet Therapy; Protein Energy Wasting Syndrome
• Intervention / Treatment: Other: Diet Therapy; Other: Control Group

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Shiraz University of Medical Sciences, Department of Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet 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.	Other: Diet 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.
Other: Control Group; 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; The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in serum Albumin	10 weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Maryam Ekramzadeh, PhD
• Collaborators: Shiraz University of Medical Sciences
• Investigators: Study Director: Zohreh Mazloom, PhD, Shiraz University of Medical Sciences, Faculty of Nutrition; Study Chair: Mohammadmahdi Sagheb, MD, Shiraz University of Medical Sciences, Nephrology Urology Research Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Estimate): January 8, 2014
• Last Update Submitted That Met QC Criteria: January 7, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Inflammation; Diet; Hemodialysis; Malnutrition
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Inflammation; Malnutrition; Wasting Syndrome; Cachexia
• Other Study ID Numbers: 916425