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

Primary Purpose

Inflammation, Malnutrition, Protein Energy Wasting Syndrome

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Diet Therapy
Control Group
Sponsored by
Maryam Ekramzadeh, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring Hemodialysis, Diet, Inflammation, Malnutrition

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shiraz University of Medical Sciences, Department of Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Diet therapy

Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in serum Albumin

Secondary Outcome Measures

Change in Subjective Global Assessment (SGA) score
Change in Malnutrition-inflammation score(MIS)
Change in serum C-Reactive Protein(CRP)
Change in serum malondialdehyde(MDA)
Change in serum Interleukin-6(IL-6)
Change in serum total antioxidant capacity(TAC)
Change in serum ferritin
Change in serum total iron binding capacity(TIBC)
Change in serum urea nitrogen
Change in serum creatinine
Change in serum phosphorus
Change in body fat mass index(BFMI)
Change in fat free mass index(FFMI)
Change in body cell mass(BCM)

Full Information

First Posted
June 6, 2013
Last Updated
January 7, 2014
Sponsor
Maryam Ekramzadeh, PhD
Collaborators
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01874106
Brief Title
Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
Official Title
Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maryam Ekramzadeh, PhD
Collaborators
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Malnutrition, Protein Energy Wasting Syndrome, Oxidative Stress, Diet Therapy
Keywords
Hemodialysis, Diet, Inflammation, Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet therapy
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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
Intervention Name(s)
Diet Therapy
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks.
Primary Outcome Measure Information:
Title
Change in serum Albumin
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change in Subjective Global Assessment (SGA) score
Time Frame
10 weeks
Title
Change in Malnutrition-inflammation score(MIS)
Time Frame
10 weeks
Title
Change in serum C-Reactive Protein(CRP)
Time Frame
10 weeks
Title
Change in serum malondialdehyde(MDA)
Time Frame
10 weeks
Title
Change in serum Interleukin-6(IL-6)
Time Frame
10 weeks
Title
Change in serum total antioxidant capacity(TAC)
Time Frame
10 weeks
Title
Change in serum ferritin
Time Frame
10 weeks
Title
Change in serum total iron binding capacity(TIBC)
Time Frame
10 weeks
Title
Change in serum urea nitrogen
Time Frame
10 weeks
Title
Change in serum creatinine
Time Frame
10 weeks
Title
Change in serum phosphorus
Time Frame
10 weeks
Title
Change in body fat mass index(BFMI)
Time Frame
10 weeks
Title
Change in fat free mass index(FFMI)
Time Frame
10 weeks
Title
Change in body cell mass(BCM)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zohreh Mazloom, PhD
Organizational Affiliation
Shiraz University of Medical Sciences, Faculty of Nutrition
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammadmahdi Sagheb, MD
Organizational Affiliation
Shiraz University of Medical Sciences, Nephrology Urology Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
Shiraz University of Medical Sciences, Department of Nutrition
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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