Clinical trial NCT01890382: Protein Intake and Resistance Training in Aging
Official title: Different Protein and Derivatives Supplementation Strategies Combined With Resistance Training in Pre-frail and Frail Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: resistance exercise
protein
creatine
leucine
aging
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Resistance training combined with protein or amino acids supplementation has been shown to be promising for mitigating age-related disabilities and comorbidities. Randomized controlled trials supporting this possibility are still scarce. These series of clinical trials aim to investigate the chronic effects of different strategies of protein and derivatives supplementation in association with resistance training on selected health-related parameters in pre-frail and frail elderly.This is a 16-month, double-blind, randomized, placebo-controlled, parallel-group clinical trial involving a series of investigations. Participants will be divided into nine groups, allowing the assessement of the effects of (1) isolated leucine supplementation; (2) protein source (whey vs. soy); (3) combination of whey protein and creatine; and (4) sexual dimorphism to the response of protein intake plus resistance training (men vs. women). All participants will undergo a supervised, resistance training program.


Eligibility criteria: Inclusion Criteria:

* elderly people
* frailty or pre-frailty, according to Fried et al., (2001) criteria.

Exclusion Criteria:

* on exogenous insulin and steroid-based drugs
* 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

Primary outcomes:
measure: lean mass
timeFrame: 4 months
measure: muscle function
timeFrame: 4 months
Secondary outcomes:
measure: bone mass
timeFrame: 4 months
measure: insulin sensitivity
timeFrame: 4 months
measure: health related-quality of life
timeFrame: 4 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.