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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

The effect of whey protein and ascorbic acid supplementation on nutritional status, inflammation, oxidative stress and quality of life: randomized clinical trial in hemodialysis patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-65b8f4
Enrollment
Unknown
Registered
2019-04-22
Start date
2018-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal dialysis

Interventions

112 Patients will be randomized into four groups in the ratio of 1: 1: 1: 1. The patients in group 1 (n=28) will receive 1 glass of water (150 ml) with whey proteins (17.6 g of protein) and 250 mg of
Dietary supplement
SP6.051.227

Sponsors

Universidade Federal de Santa Catarina
Lead Sponsor
Universidade Federal de Santa Catarina
Collaborator

Eligibility

Age
19 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Brazil

Contacts

Public ContactElisabeth Wazlawik

Universidade Federal de Santa Catarina

e.wazlawik@ufsc.br3721-2281

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 23, 2026