Chronic Kidney Disease
Conditions
Keywords
whey protein, malnutrition, oxidative stress, hemodialysis
Brief summary
The purpose of the study is to evaluate the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients
Detailed description
The aim of this interventional study was to evaluate the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients. 92 hemodialysis patients were selected for the study. Inclusion criteria included: mean age of 17-65 years old; having mild, moderate or severe malnutrition based on the SGA (subjective global assessment) assessment; being dialyzed at least 2 times a week for 3 months. Exclusion criteria included: hospitalization in the last month; active infection; using immunosuppressant drugs or multi-vitamins; pregnancy. The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.Informed consent were signed by all of them for participating in the study. Weight and height of the patients were recorded for BMI (body mass index) calculation. Then, all of the patients were assigned into 4 groups: 1. consumption of 220 milliliters of whey drink three times a week, 2. consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week, 3. consumption of 400 milligrams of vitamin E three times a week, 4. control group: no intervention. Patients were followed for 2 months. At the beginning and the end of the 2-month intervention period, 10 milliliters of blood were taken from all of the patients and nutritional status of the patients were assessed as the primary outcome. Serum levels of malondialdehyde, c-reactive protein, albumin, transferrin and lipoproteins were also measured. SGA, MIS and SF-12 questionnaires were filled for all of the patients at the beginning and the end of the study.
Interventions
DIETARY_SUPPLEMENTwhey drink,
consumption of 220 milliliters of whey drink three times a week,
DIETARY_SUPPLEMENTwhey drink fortified with vitaminE
consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
DIETARY_SUPPLEMENTvitamin E
consumption of 400 milligrams of vitamin E three times a week,
Sponsors
Shiraz University of Medical Sciences
Mohammad Hassan Eftekhari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* mean age of 17-65 years old; * having mild, moderate or severe malnutrition based on the SGA (subjective global assessment) assessment; * be dialyzed at least 2 times a week for 3 months
Exclusion criteria
* hospitalization in the last month; * active infection; * using immunosuppressant drugs or multi-vitamins; * pregnancy, consuming whey or soy products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| malnutrition (based on SGA assessment) | 2 months (8 weeks) |
| Malnutrition inflammation score | 2 months (8 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| serum interleukin-6 | 2 months (8 weeks) |
| serum C-reactive protein | 2 months (8 weeks) |
| serum albumin | 2 months (8 weeks) |
| serum HDL-c | 2 months (8 weeks) |
| serum total cholesterol | 2 months (8 weeks) |
| serum triglyceride | 2 months (8 weeks) |
| serum transferrin | 2 months (8 weeks) |
| serum malondialdehyde | 2 months (8 weeks) |
| serum calcium | 2 months (8 weeks) |
| serum phosphate | 2 months (8 weeks) |
| quality of life | 2 months (8 weeks) |
| weight | 2 months (8 weeks) |
| height | 2 months (8 week) |
| Body mass index | 2 months (8 weeks) |
| serum creatinine | 2 months (8 weeks) |
| BUN (blood urea nitrogen) | 2 months (8 weeks) |
Outcome results
None listed