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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01890382
Other study ID # The Pro Elderly Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2015
Est. completion date August 30, 2017

Study information

Verified date February 2019
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date August 30, 2017
Est. primary completion date August 30, 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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


Locations

Country Name City State
Brazil University of Sao Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary lean mass assessed by Dual-energy X-ray absorptiometry 4 months
Primary muscle function assessed by a battery of physical tests 4 months
Secondary bone mass assessed by Dual-energy X-ray absorptiometry 4 months
Secondary insulin sensitivity assessed by homeostasis model assessment (HOMA index) 4 months
Secondary health related-quality of life assessed by Short-Form Health Survey (SF-36) (score range: 0 to 100, higher values mean better quality of life) 4 months
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