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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

Effect of oral supplementation of Whey proteins and Ascorbic acid on markers of nutritional status, inflammatory methods, oxidative stress and quality of life: randomized clinical test in Hemodialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-978gy8
Enrollment
Unknown
Registered
2020-04-22
Start date
2019-12-01
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

Patients will be randomized into two groups at a 1:1 ratio. Patients in group 1 (n=20) received ¼ of a glass of water (50 mL) with whey proteins (20 g of the module), 1 capsule containing 250 mg of as
Dietary supplement
G07.203.300.456

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 two 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 8 weeks, based on the observation of a variation of at least 5% in the pre- and post-intervention measurements

Secondary

MeasureTime frame
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

Countries

Brazil

Contacts

Public ContactElisabeth;Elisabeth Wazlawik;Wazlawik

Universidade Federal de Santa Catarina;Universidade Federal de Santa Catarina

e.wazlawik@ufsc.br;e.wazlawik@ufsc.br3721-2281;+55 48 3721-6131

Outcome results

None listed

Source: REBEC (via WHO ICTRP)