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

Maryam Ekramzadeh, PhD

Status: Completed

Conditions: Protein Energy Wasting Syndrome; Inflammation; Malnutrition; Diet Therapy; Oxidative Stress

Treatments: Other: Diet Therapy; Other: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01874106

916425

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Diet therapy

Experimental group

Description:

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.

Treatment:

Other: Diet Therapy

Control Group

Other group

Description:

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

Treatment:

Other: Control Group