The effect of whey protein and acid ascorbic supplementation on nutritional status, inflammation, oxidative stress and quality of life: a study in patients with chronic renal disease on hemodialysis

Not Applicable

Recruiting

• Conditions: renal dialysis; Renal insufficiency, chronic; E02.870.300; C12.777.419.780.750

• Registration Number: RBR-65b8f4
• Lead Sponsor: niversidade Federal de Santa Catarina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Be 19 years of age or over; have a diagnosis of CKD; perform HD three times a week in a period of three months and sign the Informed Consent Form

Exclusion Criteria

Make use of antioxidants like Vitamin C or E; amino acids; protein or ketoacid supplements, or immunosuppressive drugs within 2 months prior to enrollment or who had an infection or hospitalization in the month prior to the start of the study. Being a carrier of the acquired immunodeficiency virus (HIV); to present a diagnosis of cancer; advanced heart failure, chronic lung disease; liver disease; metal parts in the body like cardiac stimulators, stents, metal dots; have atrophied or amputated limbs; to be hospitalized; being pregnant or breastfeeding; have sequelae that prevent the measurement of parameters and have no ability to understand or communicate

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant increase in body mass index assessed by weight and stature and serum albumin measured by the green bromocresol method after 12 weeks, based on the observation of a variation of at least 5% in the pre- and post-intervention measurements

Secondary Outcome Measures

Name	Time	Method
Reduction of oxidative stress and inflammation evaluated according to laboratory protocols, increase in the quality of life evaluated by the SF-36 generic quality of life questionnaire and nutritional status evaluated through bioelectrical impedance, skinfolds, dynamometer and nutritional assessment questionnaires Subjective evaluation Global, Malnutrition and Inflammation Score and Nutrition Risk Tracking 2002, based on the observation of a variation of at least 5% in the pre- and post-intervention measurements