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OpenTrials
Completed

NCT Number: NCT01890382

Protein Intake and Resistance Training in Aging

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo

São Paulo, 05508030, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein

Dietary Supplement

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

whey plus creatine

Dietary Supplement

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

Leucine supplementation

Dietary Supplement

7.5 g/d in total; three times per day

Soy protein

Dietary Supplement

30 g in total; twice a day

Creatine

Dietary Supplement

6.0 g in total; twice a day

Placebo

Dietary Supplement

Primary outcomes

  1. lean mass

    Time frame: 4 months

    assessed by Dual-energy X-ray absorptiometry

  2. muscle function

    Time frame: 4 months

    assessed by a battery of physical tests

Secondary outcomes

  1. bone mass

    Time frame: 4 months

    assessed by Dual-energy X-ray absorptiometry

  2. insulin sensitivity

    Time frame: 4 months

    assessed by homeostasis model assessment (HOMA index)

  3. health related-quality of life

    Time frame: 4 months

    assessed by Short-Form Health Survey (SF-36) (score range: 0 to 100, higher values mean better quality of life)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2013
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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