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

NCT ID: NCT01874106

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diet Therapy

Intervention Type: 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

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

Group Type: OTHER

Control Group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: collaborator

Maryam Ekramzadeh, PhD

OTHER

Sponsor Role: lead

Responsible Party

Maryam Ekramzadeh, PhD

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zohreh Mazloom, PhD

Role: STUDY_DIRECTOR

Shiraz University of Medical Sciences, Faculty of Nutrition

Mohammadmahdi Sagheb, MD

Role: STUDY_CHAIR

Shiraz University of Medical Sciences, Nephrology Urology Research Center

Locations

Shiraz University of Medical Sciences, Department of Nutrition

Shiraz, Fars, Iran

Countries

Iran

Other Identifiers

916425

Identifier Type: -

Identifier Source: org_study_id