Protein Intake and Resistance Training in Aging

NCT01890382 | Completed

• 1 other identifier: The Pro Elderly Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly Syndrome

Keywords

resistance exercise; protein; creatine; leucine; aging

Outcome Measures

Primary Outcomes (2)

• lean mass

  assessed by Dual-energy X-ray absorptiometry

  4 months

• muscle function

  assessed by a battery of physical tests

  4 months

Secondary Outcomes (3)

• bone mass

  4 months

• insulin sensitivity

  4 months

• health related-quality of life

  4 months

Study Arms (6)

Control

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

whey protein

EXPERIMENTAL

Dietary Supplement: Whey protein

soy protein

EXPERIMENTAL

Dietary Supplement: soy protein

leucine supplementation

EXPERIMENTAL

Dietary Supplement: leucine supplementation

whey plus creatine

EXPERIMENTAL

Dietary Supplement: whey plus creatine

creatine

EXPERIMENTAL

Dietary Supplement: creatine

Interventions

Whey protein DIETARY_SUPPLEMENT

30 g in total; twice a day (morning and evening)

whey protein

whey plus creatine DIETARY_SUPPLEMENT

whey protein combined with creatine (30 g and 6.0 g in total; twice a day, respectively)

whey plus creatine

leucine supplementation DIETARY_SUPPLEMENT

7.5 g/d in total; three times per day

leucine supplementation

soy protein DIETARY_SUPPLEMENT

30 g in total; twice a day

soy protein

creatine DIETARY_SUPPLEMENT

6.0 g in total; twice a day

creatine

placebo DIETARY_SUPPLEMENT

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, 05508030, Brazil

Location

Related Publications (2)

• 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.

  PMID: 34358827 DERIVED

• 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.

  PMID: 27224505 DERIVED

MeSH Terms

Interventions

Whey Proteins; Whey; Creatine; Soybean Proteins

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Guanidines; Amidines; Organic Chemicals; Amino Acids; Plant Proteins; Plant Proteins, Dietary; Soy Foods; Vegetable Products; Vegetables

Study Officials

• Bruno Gualano, Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 1, 2013
• Study Start: October 1, 2015
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

BR (1)