An interventional study of Whey Protein and Control in Sarcopenia and Muscle Atrophy, sponsored by Coventry University. Completed at 1 site in United Kingdom. Open to male participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by Coventry University · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Dietary Supplement: Control
Dietary Supplement: Whey Protein
Dietary Supplement: Control · Other: Resistance Exercise
Dietary Supplement: Whey Protein · Other: Resistance Exercise
25 g whey protein supplementation twice daily (breakfast and lunch)
23.75 g maltodextrin twice daily (breakfast and lunch)
60 minutes of resistance exercise twice a week
Changes in components of 24-h energy expenditure and its components (kcal/d)
Measured by whole-room calorimetry
Time frame: 0 to 12 weeks
Changes in body composition (kg)
Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis
Time frame: 0 to 12 weeks
Changes in 24-h substrate oxidation (g/d)
Measured by whole-room calorimetry
Time frame: 0 to 12 weeks
Biochemical: Appetite hormones
Ghrelin, leptin, and PYY
Time frame: 0 to 12 weeks
Biochemical: Insulin Resistance (HOMAR-IR)
Time frame: 0 to 12 weeks
Salivary:Diurnal Cortisol
Time frame: 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
Time frame: 0 to 12 weeks
Interstitial Glucose
24 Hour Continuous Glucose Monitoring
Time frame: 0 to 12 weeks
Biochemical: Insulin-Like Growth Factor 1 (IGF-1)
Time frame: 0 to 12 weeks
Isotonic Strength (kg) - Leg press and leg extension
Time frame: 0 to 12 weeks
Short Physical Performance Battery (SPPB)
Balance, Gait speed and time to sit and stand from a chair 5 times
Time frame: 0 to 12 weeks
Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery
Time frame: 0 to 12 weeks
Handgrip strength (kg)
Time frame: 0 to 12 weeks
Biochemical: Myostatin
Time frame: 0 to 12 weeks
Habitual Physical Activity
Accelerometer
Time frame: 0 to 12 weeks
Endurance (Six Minute Walk Test)
Time frame: 0 to 12 weeks
Plan to share: No
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Coventry University