Protein Intake and Resistance Training in Aging

Frail Elderly Syndrome Clinical Trial

Official title:

Different Protein and Derivatives Supplementation Strategies Combined With Resistance Training in Pre-frail and Frail Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890382
• Other study ID #: The Pro Elderly Study
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Frail Elderly Syndrome

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