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| Name | Class |
|---|---|
| University Hospitals Coventry and Warwickshire NHS Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator |
| |
| Whey Protein | Experimental |
| |
| Resistance Exercise + Control | Experimental |
| |
| Resistance Exercise + Whey Protein | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey Protein | Dietary Supplement | 25 g whey protein supplementation twice daily (breakfast and lunch) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical: Appetite hormones | Ghrelin, leptin, and PYY | 0 to 12 weeks |
| Biochemical: Insulin Resistance (HOMAR-IR) | 0 to 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek Renshaw, PhD | Coventry University | Study Director |
| John Hattersley, PhD | University Hosptials Coventry and Warwickshire NHS Trust | Study Director |
| Michael Duncan, PhD | Coventry University | Study Director |
| Corbin Griffen, MSc | Coventry University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coventry University | Coventry | West Midlands | CV1 5FB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37815091 | Derived | Griffen C, Renshaw D, Duncan M, Weickert MO, Hattersley J. Changes in 24-h energy expenditure, substrate oxidation, and body composition following resistance exercise and a high protein diet via whey protein supplementation in healthy older men. Physiol Rep. 2022 Jun;10(11):e15268. doi: 10.14814/phy2.15268. | |
| 34896568 | Derived |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| Control | Dietary Supplement | 23.75 g maltodextrin twice daily (breakfast and lunch) |
|
| Resistance Exercise | Other | 60 minutes of resistance exercise twice a week |
|
| 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 |
| Griffen C, Duncan M, Hattersley J, Weickert MO, Dallaway A, Renshaw D. Effects of resistance exercise and whey protein supplementation on skeletal muscle strength, mass, physical function, and hormonal and inflammatory biomarkers in healthy active older men: a randomised, double-blind, placebo-controlled trial. Exp Gerontol. 2022 Feb;158:111651. doi: 10.1016/j.exger.2021.111651. Epub 2021 Dec 9. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |