Skip to main content
OpenTrials
Completed

NCT Number: NCT01874106

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammation Diet Therapy Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms Protein Energy Wasting Syndrome

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shiraz University of Medical Sciences, Department of Nutrition

Shiraz, Fars, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in serum Albumin

    Time frame: 10 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Maryam Ekramzadeh, PhD

Other

Collaborators

  • Shiraz University of Medical Sciences

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 10, 2013
Registry last updated
Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.