Protein Intake and Resistance Training in Aging

University of Sao Paulo

Status: Completed

Conditions: Frail Elderly Syndrome

Treatments: Dietary Supplement: Whey protein; Dietary Supplement: creatine; Dietary Supplement: leucine supplementation; Dietary Supplement: whey plus creatine; Dietary Supplement: placebo; Dietary Supplement: soy protein

Study type: Interventional

Funder types: Other

Identifiers

NCT01890382

The Pro Elderly Study

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 6 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

alanine as placebo to leucine (same dosage); corn starch as placebo to protein and/or creatine (same dosage)

Treatment:

Dietary Supplement: placebo

whey protein

Experimental group

Treatment:

Dietary Supplement: Whey protein

soy protein

Experimental group

Treatment:

Dietary Supplement: soy protein

leucine supplementation

Experimental group

Treatment:

Dietary Supplement: leucine supplementation

whey plus creatine

Experimental group

Treatment:

Dietary Supplement: whey plus creatine

creatine

Experimental group

Treatment:

Dietary Supplement: creatine