Effect of oral Whey protein and Vitamin C supplementation on markers of nutritional status, inflammation, oxidative stress and quality of life: randomized clinical trial in patients undergoing Hemodialysis

Not Applicable

• Conditions: Renal insufficiency, chronic; renal dialysis; C12.777.419.780.750.500

• Registration Number: RBR-978gy8
• 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: 2020-04-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• 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 two 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 8 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
Decreased oxidative stress and applicable inflammation, according to laboratory protocols, increased quality of life assessed by the generic SF-36 quality of life questionnaire and improves nutritional status assessed through bioelectrical impedance (increase in muscle mass%), skin folds , dynamometer and nutritional assessment questionnaires improved in the Subjective Global Assessment, decreased malnutrition and inflammation score and nutritional risk tracking 2002, based on the observation of a variation of at least 5% in the pre and post-intervention measurements