Protein Intake and Resistance Training in Aging

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

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.

Study Overview

• Status: Completed
• Conditions: Frail Elderly Syndrome
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: Whey protein; Dietary supplement: soy protein; Dietary supplement: leucine supplementation; Dietary supplement: whey plus creatine; Dietary supplement: creatine

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508030
    • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; alanine as placebo to leucine (same dosage); corn starch as placebo to protein and/or creatine (same dosage)	Dietary supplement: placebo
Experimental: whey protein	Dietary supplement: Whey protein; 30 g in total; twice a day (morning and evening)
Experimental: soy protein	Dietary supplement: soy protein; 30 g in total; twice a day
Experimental: leucine supplementation	Dietary supplement: leucine supplementation; 7.5 g/d in total; three times per day
Experimental: whey plus creatine	Dietary supplement: whey plus creatine; whey protein combined with creatine (30 g and 6.0 g in total; twice a day, respectively)
Experimental: creatine	Dietary supplement: creatine; 6.0 g in total; twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lean mass	assessed by Dual-energy X-ray absorptiometry	4 months
muscle function	assessed by a battery of physical tests	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone mass	assessed by Dual-energy X-ray absorptiometry	4 months
insulin sensitivity	assessed by homeostasis model assessment (HOMA index)	4 months
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• Roschel H, Hayashi AP, Fernandes AL, Jambassi-Filho JC, Hevia-Larrain V, de Capitani M, Santana DA, Goncalves LS, de Sa-Pinto AL, Lima FR, Sapienza MT, Duarte AJS, Pereira RMR, Phillips SM, Gualano B. Supplement-based nutritional strategies to tackle frailty: A multifactorial, double-blind, randomized placebo-controlled trial. Clin Nutr. 2021 Aug;40(8):4849-4858. doi: 10.1016/j.clnu.2021.06.024. Epub 2021 Jul 3.
• Collins J, Longhurst G, Roschel H, Gualano B. Resistance Training and Co-supplementation with Creatine and Protein in Older Subjects with Frailty. J Frailty Aging. 2016;5(2):126-34. doi: 10.14283/jfa.2016.85.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: June 26, 2013
• First Posted (Estimate): July 1, 2013

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: aging; resistance exercise; protein; leucine; creatine
• Other Study ID Numbers: The Pro Elderly Study