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

Not Applicable
Completed
Conditions
Sarcopenia
Muscle Atrophy
Interventions
Dietary Supplement: Control
Dietary Supplement: Whey Protein
Other: Resistance Exercise
Registration Number
NCT03299972
Lead Sponsor
Coventry University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
39
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Resistance Exercise + ControlControl-
ControlControl-
Resistance Exercise + Whey ProteinResistance Exercise-
Whey ProteinWhey Protein-
Resistance Exercise + ControlResistance Exercise-
Resistance Exercise + Whey ProteinWhey Protein-
Primary Outcome Measures
NameTimeMethod
Changes in components of 24-h energy expenditure and its components (kcal/d)0 to 12 weeks

Measured by whole-room calorimetry

Changes in body composition (kg)0 to 12 weeks

Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis

Changes in 24-h substrate oxidation (g/d)0 to 12 weeks

Measured by whole-room calorimetry

Secondary Outcome Measures
NameTimeMethod
Isotonic Strength (kg) - Leg press and leg extension0 to 12 weeks
Biochemical: Myostatin0 to 12 weeks
Biochemical: Inflammtion0 to 12 weeks

Tumor necrosis factor alpha (TNF-α), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), Annexin A1

Interstitial Glucose0 to 12 weeks

24 Hour Continuous Glucose Monitoring

Habitual Physical Activity0 to 12 weeks

Accelerometer

Biochemical: Insulin Resistance (HOMAR-IR)0 to 12 weeks
Biochemical: Appetite hormones0 to 12 weeks

Ghrelin, leptin, and PYY

Salivary:Diurnal Cortisol0 to 12 weeks
Biochemical: Insulin-Like Growth Factor 1 (IGF-1)0 to 12 weeks
Handgrip strength (kg)0 to 12 weeks
Endurance (Six Minute Walk Test)0 to 12 weeks
Short Physical Performance Battery (SPPB)0 to 12 weeks

Balance, Gait speed and time to sit and stand from a chair 5 times

Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery0 to 12 weeks

Trial Locations

Locations (1)

Coventry University

🇬🇧

Coventry, West Midlands, United Kingdom

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