Public trial
RBR-7nk6g84 Effects of Protein supplementation on body composition, handshake strength and quality of life of patients undergoing Sp...
Date of registration: 02/02/2021 (mm/dd/yyyy)Last approval date : 02/02/2021 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
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Effects of Protein supplementation on body composition, handgrip strength and quality of life of patients undergoing Spine surgery: A controlled clinical trial
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Efeitos de suplementação Proteica na composição corporal, força de preensão palmar e qualidade de vida de pacientes submetidos à Cirurgia de Coluna: um ensaio clínico controlado
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Effects of Protein supplementation on body composition, handgrip strength and quality of life of patients undergoing Spine surgery: A controlled clinical trial
Trial identification
- UTN code:
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Public title:
en
Effects of Protein supplementation on body composition, handshake strength and quality of life of patients undergoing Spine surgery
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Efeitos de suplementação de proteína na composição do corpo, força de aperto de mão e qualidade de vida de pacientes submetidos à Cirurgia de coluna
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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U1111-1263-5568
Issuing authority:
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21465919.0.0000.0023
Issuing authority: Plataforma Brasil
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4.437.981
Issuing authority: Comitê de Ética em Pesquisa do Centro Universitário de Brasília
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U1111-1263-5568
Sponsors
- Primary sponsor: Hospital de Acidentados Clínica Santa Isabel
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Secondary sponsor:
- Institution: Hospital de Acidentados Clínica Santa Isabel
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Supporting source:
- Institution: Hospital de Acidentados Clínica Santa Isabel
- Institution: Nestlé Health Science
Health conditions
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Health conditions:
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Spine fusion; sarcopenia
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Artrodese de coluna; sarcopenia
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General descriptors for health conditions:
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Specific descriptors:
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Z.98.1 Spine Fusion
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Z.98.1 Artrodese de coluna
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M62.5 Sarcopenia
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M62.5 Sarcopenia
Interventions
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Interventions:
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The placebo group (50 patients) will receive two unflavored maltodextrin envelopes, 15 g each (114 Kcal / 0g protein) The experimental group (50 patients) will receive two 15g whey protein envelopes (104 Kcal / 26g protein). Patients will be instructed to dilute the envelopes in 200 mL of water and drink once a day, in the morning, for two weeks prior to surgery (± 1 week) and 4 weeks after surgery (± 1 week), totaling both groups 42 days of supplement or placebo use.
pt-br
O grupo controle (50 pacientes) receberá dois envelopes de maltodextrina, sem sabor, 15 g cada (114 Kcal /0g proteína). O grupo experimental (50 pacientes) receberá dois envelopes de whey protein com 15g cada (104 Kcal /26g de proteína). Os pacientes serão orientados a diluir os envelopes em 200 mL de água e beber uma vez por dia, pela manhã, durante duas semanas anteriores à cirurgia (± 1 semana) e 4 semanas após a cirurgia (±1 semana), totalizando em ambos os grupos 42 dias de uso de suplemento ou placebo.
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Descriptors:
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A12.790.520.500 Whey Proteins
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A12.790.520.500 Proteínas do Soro do Leite
Recruitment
- Study status: Not yet recruiting
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Countries
- Brazil
- Date first enrollment: 02/01/2021 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 100 - 50 Y 75 Y -
Inclusion criteria:
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Patients undergoing lumbar or thoraco- lumbar spine surgery regardless of etiology aged between 50 and 75 years.
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Pacientes submetidos à cirurgia de coluna lombar ou toraco-lombar independente da etiologia com idade entre 50 e 75 anos.
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Exclusion criteria:
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Patients with chronic kidney disease with a glomerular filtration rate below 30 ml min; diabetic patients treated with insulin therapy; allergic to milk protein; with malignancy; bedridden previously for diseases not related to spine pathology; with inability to complete quality of life questionnaires; previously submitted to spine surgery; with spinal neurological deficit.
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Portadores de doença renal crônica com taxa de filtração glomerular inferior a 30 ml por min; diabéticos tratados com insulinoterapia; alérgicos à proteína do leite; portadores de malignidade; acamados previamente por doenças não relacionadas a patologia de coluna; com inabilidade para preenchimento de questionários de qualidade de vida; previamente submetidos à cirurgia de coluna; com déficit neurológico medular.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Treatment Parallel 2 Double-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
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It is expected to reduce the loss of handgrip strength after lumbar or thoraco-lumbar spine surgery, with statistical significance, measured 3 months after surgery
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Espera-se reduzir a perda de força de preensão palmar após cirurgia de coluna lombar ou toraco-lombar, com significância estátística, aferida 3 meses após cirurgia
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Secondary outcomes:
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It is expected to reduce the loss of appendicular muscle mass index measured 15 days and 3 months by DEXA, after lumbar or thoraco-lumbar spine surgery, with statistical significance
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Espera-se reduzir a perda de Índice de massa muscular apendicular aferida 15 dias e 3 meses por DEXA, após cirurgia de coluna lombar ou toraco-lombar, com significância estatística
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Assess improvement in SF-36 and Oswestry Desability Index scores in 15 days and 3 months, with statistical significance
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Avaliar melhora nos scores SF-36 e Oswestry Desability Index em 15 dias e 3 meses, com significância estatística
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To evaluate the reduction in the rate of surgical site infection after surgery, with statistical significance
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Avaliar redução da taxa de infecção de sítio cirúrgico após cirurgia, com significância estatística
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Inflammatory markers (C-reactive protein and albumin) in 15 days after surgery
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marcadores inflamatórios (proteína C reativa e albumina) em 15 dias após cirurgia
Contacts
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Public contact
- Full name: Rodrigo Costa Gonçalves
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- Address: Rua T-51 n.978 apt 2201A Bueno
- City: Goiânia / Brazil
- Zip code: 74215210
- Phone: 55 62 981679626
- Email: rodimed@gmail.com
- Affiliation:
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Scientific contact
- Full name: Rodrigo Costa Gonçalves
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- Address: Rua T-51 n.978 apt 2201A Bueno
- City: Goiânia / Brazil
- Zip code: 74215210
- Phone: 55 62 981679626
- Email: rodimed@gmail.com
- Affiliation:
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Site contact
- Full name: Rodrigo Costa Gonçalves
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- Address: Rua T-51 n.978 apt 2201A Bueno
- City: Goiânia / Brazil
- Zip code: 74215210
- Phone: 55 62 981679626
- Email: rodimed@gmail.com
- Affiliation:
Additional links:
Total de Ensaios Clínicos 16962.
Existem 8357 ensaios clínicos registrados.
Existem 4701 ensaios clínicos recrutando.
Existem 239 ensaios clínicos em análise.
Existem 5773 ensaios clínicos em rascunho.