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

This study has been completed.
Sponsor:
Collaborator:
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
Maryam Ekramzadeh, PhD, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01874106
First received: June 6, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Inflammation
Malnutrition
Protein Energy Wasting Syndrome
Oxidative Stress
Diet Therapy
Other: Diet Therapy
Other: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Change in serum Albumin [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Subjective Global Assessment (SGA) score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in Malnutrition-inflammation score(MIS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in serum C-Reactive Protein(CRP) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in serum malondialdehyde(MDA) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in serum Interleukin-6(IL-6) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in serum total antioxidant capacity(TAC) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in serum ferritin [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in serum total iron binding capacity(TIBC) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in serum urea nitrogen [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in serum creatinine [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in serum phosphorus [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in body fat mass index(BFMI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in fat free mass index(FFMI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in body cell mass(BCM) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2012
Study Completion Date: August 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874106

Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences, Department of Nutrition
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Maryam Ekramzadeh, PhD
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
  More Information

No publications provided

Responsible Party: Maryam Ekramzadeh, PhD, PhD, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01874106     History of Changes
Other Study ID Numbers: 916425
Study First Received: June 6, 2013
Last Updated: January 7, 2014
Health Authority: Iran: Shiraz University of Medical Sciences vice chancellor for research

Keywords provided by Shiraz University of Medical Sciences:
Hemodialysis
Diet
Inflammation
Malnutrition

Additional relevant MeSH terms:
Inflammation
Malnutrition
Nutrition Disorders
Wasting Syndrome
Metabolic Diseases
Pathologic Processes
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014