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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874106
• Other study ID #: 916425
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: January 7, 2014
• Start date: October 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Shiraz University of Medical Sciences vice chancellor for research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences, Department of Nutrition	Shiraz	Fars

Sponsors (2)

Lead Sponsor	Collaborator
Maryam Ekramzadeh, PhD	Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum Albumin		10 weeks	No
Secondary	Change in Subjective Global Assessment (SGA) score		10 weeks	No
Secondary	Change in Malnutrition-inflammation score(MIS)		10 weeks	No
Secondary	Change in serum C-Reactive Protein(CRP)		10 weeks	No
Secondary	Change in serum malondialdehyde(MDA)		10 weeks	No
Secondary	Change in serum Interleukin-6(IL-6)		10 weeks	No
Secondary	Change in serum total antioxidant capacity(TAC)		10 weeks	No
Secondary	Change in serum ferritin		10 weeks	No
Secondary	Change in serum total iron binding capacity(TIBC)		10 weeks	No
Secondary	Change in serum urea nitrogen		10 weeks	No
Secondary	Change in serum creatinine		10 weeks	No
Secondary	Change in serum phosphorus		10 weeks	No
Secondary	Change in body fat mass index(BFMI)		10 weeks	No
Secondary	Change in fat free mass index(FFMI)		10 weeks	No
Secondary	Change in body cell mass(BCM)		10 weeks	No