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

• Sponsor: Maryam Ekramzadeh, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01874106
• Collaborator: Shiraz University of Medical Sciences (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 12

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Oct 1, 2012
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

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.
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.	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.

Outcome Measures

Primary Outcome Measures

1. Change in serum Albumin [10 weeks]

Secondary Outcome Measures

1. Change in Subjective Global Assessment (SGA) score [10 weeks]

2. Change in Malnutrition-inflammation score(MIS) [10 weeks]

3. Change in serum C-Reactive Protein(CRP) [10 weeks]

4. Change in serum malondialdehyde(MDA) [10 weeks]

5. Change in serum Interleukin-6(IL-6) [10 weeks]

6. Change in serum total antioxidant capacity(TAC) [10 weeks]

7. Change in serum ferritin [10 weeks]

8. Change in serum total iron binding capacity(TIBC) [10 weeks]

9. Change in serum urea nitrogen [10 weeks]

10. Change in serum creatinine [10 weeks]

11. Change in serum phosphorus [10 weeks]

12. Change in body fat mass index(BFMI) [10 weeks]

13. Change in fat free mass index(FFMI) [10 weeks]

14. Change in body cell mass(BCM) [10 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maryam Ekramzadeh, PhD, PhD, Shiraz University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01874106
• Other Study ID Numbers: 916425
• First Posted: Jun 10, 2013
• Last Update Posted: Jan 8, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Maryam Ekramzadeh, PhD, PhD, Shiraz University of Medical Sciences: Hemodialysis; Diet; Inflammation; Malnutrition
• Additional relevant MeSH terms: Malnutrition; Wasting Syndrome; Inflammation; Cachexia

Study Results

No Results Posted as of Jan 8, 2014