Protein Intake and Resistance Training in Aging

Study Overview
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Brief Summary
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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.

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

Conditions
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Frail Elderly Syndrome

Intervention / Treatment
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* Dietary Supplement: Whey protein
* Dietary Supplement: whey plus creatine
* Dietary Supplement: leucine supplementation
* Dietary Supplement: soy protein
* Dietary Supplement: creatine
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resistance exercise, protein, creatine, leucine, aging