Frail Elderly Syndrome
Conditions
Keywords
resistance exercise, protein, creatine, leucine, aging
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.
Interventions
DIETARY_SUPPLEMENTWhey protein
30 g in total; twice a day (morning and evening)
DIETARY_SUPPLEMENTwhey plus creatine
whey protein combined with creatine (30 g and 6.0 g in total; twice a day, respectively)
DIETARY_SUPPLEMENTleucine supplementation
7.5 g/d in total; three times per day
DIETARY_SUPPLEMENTsoy protein
30 g in total; twice a day
DIETARY_SUPPLEMENTcreatine
6.0 g in total; twice a day
DIETARY_SUPPLEMENTplacebo
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| muscle function | 4 months | assessed by a battery of physical tests |
| lean mass | 4 months | assessed by Dual-energy X-ray absorptiometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bone mass | 4 months | assessed by Dual-energy X-ray absorptiometry |
| insulin sensitivity | 4 months | assessed by homeostasis model assessment (HOMA index) |
| health related-quality of life | 4 months | assessed by Short-Form Health Survey (SF-36) (score range: 0 to 100, higher values mean better quality of life) |
Countries
Brazil
Outcome results
None listed