Protein Intake and Resistance Training in Aging

Not Applicable

Completed

• Conditions: Frail Elderly Syndrome
• Interventions: Dietary Supplement: Whey protein; Dietary Supplement: soy protein; Dietary Supplement: leucine supplementation; Dietary Supplement: placebo; Dietary Supplement: whey plus creatine; Dietary Supplement: creatine

• Registration Number: NCT01890382
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-07-01
• Study Start: 2015-10-01
• Primary Completion: 2017-08-30
• Study Completion: 2017-08-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
whey protein	Whey protein	-
soy protein	soy protein	-
leucine supplementation	leucine supplementation	-
Control	placebo	alanine as placebo to leucine (same dosage); corn starch as placebo to protein and/or creatine (same dosage)
whey plus creatine	whey plus creatine	-
creatine	creatine	-

Primary Outcome Measures

Name	Time	Method
muscle function	4 months	assessed by a battery of physical tests
lean mass	4 months	assessed by Dual-energy X-ray absorptiometry

Secondary Outcome Measures

Name	Time	Method
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)
bone mass	4 months	assessed by Dual-energy X-ray absorptiometry

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil