Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men

Study Overview
=================
Brief Summary
-----------------
The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to investigate the effects of 12 weeks resistance exercise and whey protein supplementation on energy metabolism, markers of appetite, inflammation and hormonal response and body composition and strength and functional performance. Generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13 per group). Participants will be randomised to either: a) control group, b) whey protein supplement group, c) resistance exercise + control group or d) resistance exercise + whey protein supplementation group.

Detailed Description
-----------------
With demographics indicating that the world's population aged >60 years will increase from 600 million reported in 2000, to >2 billion by 2050, there is an increasing interest in health issues related to ageing. One area of particular interest is sarcopenia, defined as the progressive loss of muscle mass, strength and physical function as a consequence of ageing. Sarcopenia has been associated with an increase in cardiovascular disease, poor metabolic and cognitive function, reduced quality of life and early mortality. Studies have reported beneficial effects of both resistance exercise and increasing protein intake independently and in combination on markers of sarcopenia (mostly increases in muscle mass, strength and physical function). However, little is known about the effects of combined intervention on energy metabolism, appetite and cognitive and endocrine function. This randomised, double-blind, placebo-controlled, parallel groups trial will investigate these, alongside assessing the effects of combined intervention on total lean tissue mass, muscular strength and functional performance.

Official Title
-----------------
Effects of 12 Weeks Resistance Exercise and Whey Protein Supplementation on Energy Metabolism, Appetite, Body Composition and Biomarkers Related to Sarcopenia and Metabolic Health

Conditions
-----------------
Sarcopenia, Muscle Atrophy

Intervention / Treatment
-----------------
* Dietary Supplement: Whey Protein
* Dietary Supplement: Control
* Other: Resistance Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Retired Men aged 60-80 years Body Mass Index 18.5-30 kg/m2 Not participated in resistance exercise within the last 6 months Free from musculoskeletal injury Exclusion Criteria: Retired Men aged <60 or >80 years Current smokers, or ex-smokers ceasing <6 months ago Body Mass Index <18.5 and >30 kg/m2 Currently participating in resistance exercise regularly (within last 6 months) Not weight stable and/or looking to start a weight loss programme Individuals participating in another research project (within the last 6 months) involving dietary and/or exercise intervention Existing or past medical history of vascular disease, cancer, diabetes, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, osteoporosis or history of falls Currently taking protein/amino acid supplements regularly Currently prescribed non-steroidal anti-inflammatory medication, hormone replacement therapy (HRT), diabetic medication, beta-blockers, statins Uncontrolled blood pressure (Blood pressure >160/100 mmHg) Self-reported lactose intolerant or allergic to wheat or potatoes Individuals with a pacemaker Neuromuscular disorders or injuries

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Dietary Supplement: Control<br>* 23.75 g maltodextrin twice daily (breakfast and lunch)<br>|
| Experimental: Whey Protein<br> | Dietary Supplement: Whey Protein<br>* 25 g whey protein supplementation twice daily (breakfast and lunch)<br>|
| Experimental: Resistance Exercise + Control<br> | Dietary Supplement: Control<br>* 23.75 g maltodextrin twice daily (breakfast and lunch)<br>Other: Resistance Exercise<br>* 60 minutes of resistance exercise twice a week<br>|
| Experimental: Resistance Exercise + Whey Protein<br> | Dietary Supplement: Whey Protein<br>* 25 g whey protein supplementation twice daily (breakfast and lunch)<br>Other: Resistance Exercise<br>* 60 minutes of resistance exercise twice a week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in components of 24-h energy expenditure and its components (kcal/d) | Measured by whole-room calorimetry | 0 to 12 weeks | 
| Changes in body composition (kg) | Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis | 0 to 12 weeks | 
| Changes in 24-h substrate oxidation (g/d) | Measured by whole-room calorimetry | 0 to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical: Appetite hormones | Ghrelin, leptin, and PYY | 0 to 12 weeks | 
| Biochemical: Insulin Resistance (HOMAR-IR) |  | 0 to 12 weeks | 
| Salivary:Diurnal Cortisol |  | 0 to 12 weeks | 
| Biochemical: Inflammtion | Tumor necrosis factor alpha (TNF-α), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), Annexin A1 | 0 to 12 weeks | 
| Interstitial Glucose | 24 Hour Continuous Glucose Monitoring | 0 to 12 weeks | 
| Biochemical: Insulin-Like Growth Factor 1 (IGF-1) |  | 0 to 12 weeks | 
| Isotonic Strength (kg) - Leg press and leg extension |  | 0 to 12 weeks | 
| Short Physical Performance Battery (SPPB) | Balance, Gait speed and time to sit and stand from a chair 5 times | 0 to 12 weeks | 
| Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery |  | 0 to 12 weeks | 
| Handgrip strength (kg) |  | 0 to 12 weeks | 
| Biochemical: Myostatin |  | 0 to 12 weeks | 
| Habitual Physical Activity | Accelerometer | 0 to 12 weeks | 
| Endurance (Six Minute Walk Test) |  | 0 to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcopenia, Resistance exercise, Protein