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

NCT01874106 | Completed DMC

• 1 other identifier: 916425
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Malnutrition; Protein Energy Wasting Syndrome; Oxidative Stress; Diet Therapy

Keywords

Hemodialysis; Diet; Inflammation; Malnutrition

Outcome Measures

Primary Outcomes (1)

• Change in serum Albumin

  10 weeks

Secondary Outcomes (14)

• 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

Study Arms (2)

Diet therapy

EXPERIMENTAL

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

Control Group

OTHER

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

Interventions

Diet Therapy OTHER

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.

Diet therapy

Control Group OTHER

The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks.

Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are on hemodialysis(HD) at least two times a week for 3months or more without any internment illness or admission

You may not qualify if:

• 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

Sponsors & Collaborators

• Maryam Ekramzadeh, PhD: lead
• Shiraz University of Medical Sciences: collaborator

Study Sites (1)

Shiraz University of Medical Sciences, Department of Nutrition

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Inflammation; Malnutrition

Interventions

Diet Therapy; Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zohreh Mazloom, PhD

  Shiraz University of Medical Sciences, Faculty of Nutrition

  STUDY DIRECTOR

• Mohammadmahdi Sagheb, MD

  Shiraz University of Medical Sciences, Nephrology Urology Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: October 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

IR (1)