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

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ClinicalTrials.gov Identifier: NCT01874106
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : January 8, 2014
Sponsor:
Collaborator:
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
Maryam Ekramzadeh, PhD, Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Inflammation Malnutrition Protein Energy Wasting Syndrome Oxidative Stress Diet Therapy Other: Diet Therapy Other: Control Group Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
Study Start Date : October 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

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.
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.



Primary Outcome Measures :
  1. Change in serum Albumin [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Change in Subjective Global Assessment (SGA) score [ Time Frame: 10 weeks ]
  2. Change in Malnutrition-inflammation score(MIS) [ Time Frame: 10 weeks ]
  3. Change in serum C-Reactive Protein(CRP) [ Time Frame: 10 weeks ]
  4. Change in serum malondialdehyde(MDA) [ Time Frame: 10 weeks ]
  5. Change in serum Interleukin-6(IL-6) [ Time Frame: 10 weeks ]
  6. Change in serum total antioxidant capacity(TAC) [ Time Frame: 10 weeks ]
  7. Change in serum ferritin [ Time Frame: 10 weeks ]
  8. Change in serum total iron binding capacity(TIBC) [ Time Frame: 10 weeks ]
  9. Change in serum urea nitrogen [ Time Frame: 10 weeks ]
  10. Change in serum creatinine [ Time Frame: 10 weeks ]
  11. Change in serum phosphorus [ Time Frame: 10 weeks ]
  12. Change in body fat mass index(BFMI) [ Time Frame: 10 weeks ]
  13. Change in fat free mass index(FFMI) [ Time Frame: 10 weeks ]
  14. Change in body cell mass(BCM) [ Time Frame: 10 weeks ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Maryam Ekramzadeh, PhD, PhD, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01874106     History of Changes
Other Study ID Numbers: 916425
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014

Keywords provided by Maryam Ekramzadeh, PhD, Shiraz University of Medical Sciences:
Hemodialysis
Diet
Inflammation
Malnutrition

Additional relevant MeSH terms:
Inflammation
Malnutrition
Wasting Syndrome
Cachexia
Pathologic Processes
Nutrition Disorders
Metabolic Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Anti-Inflammatory Agents