Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2015-10-01
2017-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control
alanine as placebo to leucine (same dosage); corn starch as placebo to protein and/or creatine (same dosage)
placebo
whey protein
Whey protein
30 g in total; twice a day (morning and evening)
soy protein
soy protein
30 g in total; twice a day
leucine supplementation
leucine supplementation
7.5 g/d in total; three times per day
whey plus creatine
whey plus creatine
whey protein combined with creatine (30 g and 6.0 g in total; twice a day, respectively)
creatine
creatine
6.0 g in total; twice a day
Interventions
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Whey protein
30 g in total; twice a day (morning and evening)
whey plus creatine
whey protein combined with creatine (30 g and 6.0 g in total; twice a day, respectively)
leucine supplementation
7.5 g/d in total; three times per day
soy protein
30 g in total; twice a day
creatine
6.0 g in total; twice a day
placebo
Eligibility Criteria
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Inclusion Criteria
* frailty or pre-frailty, according to Fried et al., (2001) criteria.
Exclusion Criteria
* chronic obstructive pulmonary disease or respiratory failure
* use of protein and /or amine-based dietary supplements
* on restrictive diets (e.g. calorie or food group restrictions)
* on resistance training
* untreated cardiovascular, metabolic, or other chronic disease
* any musculoskeletal condition precluding resistance training
65 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Bruno Gualano
Professor
Principal Investigators
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Bruno Gualano, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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University of Sao Paulo
São Paulo, , Brazil
Countries
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References
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Roschel H, Hayashi AP, Fernandes AL, Jambassi-Filho JC, Hevia-Larrain V, de Capitani M, Santana DA, Goncalves LS, de Sa-Pinto AL, Lima FR, Sapienza MT, Duarte AJS, Pereira RMR, Phillips SM, Gualano B. Supplement-based nutritional strategies to tackle frailty: A multifactorial, double-blind, randomized placebo-controlled trial. Clin Nutr. 2021 Aug;40(8):4849-4858. doi: 10.1016/j.clnu.2021.06.024. Epub 2021 Jul 3.
Collins J, Longhurst G, Roschel H, Gualano B. Resistance Training and Co-supplementation with Creatine and Protein in Older Subjects with Frailty. J Frailty Aging. 2016;5(2):126-34. doi: 10.14283/jfa.2016.85.
Other Identifiers
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The Pro Elderly Study
Identifier Type: -
Identifier Source: org_study_id
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