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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03299972
Enrollment
39
Registered
2017-10-03
Start date
2017-10-27
Completion date
2019-06-30
Last updated
2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Atrophy, Sarcopenia

Keywords

Sarcopenia, Resistance exercise, Protein

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.

Interventions

DIETARY_SUPPLEMENTWhey Protein

25 g whey protein supplementation twice daily (breakfast and lunch)

DIETARY_SUPPLEMENTControl

23.75 g maltodextrin twice daily (breakfast and lunch)

OTHERResistance Exercise

60 minutes of resistance exercise twice a week

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust
CollaboratorOTHER
Coventry University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
60 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in components of 24-h energy expenditure and its components (kcal/d)0 to 12 weeksMeasured by whole-room calorimetry
Changes in body composition (kg)0 to 12 weeksFat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis
Changes in 24-h substrate oxidation (g/d)0 to 12 weeksMeasured by whole-room calorimetry

Secondary

MeasureTime frameDescription
Isotonic Strength (kg) - Leg press and leg extension0 to 12 weeks
Biochemical: Inflammtion0 to 12 weeksTumor necrosis factor alpha (TNF-α), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), Annexin A1
Interstitial Glucose0 to 12 weeks24 Hour Continuous Glucose Monitoring
Biochemical: Appetite hormones0 to 12 weeksGhrelin, leptin, and PYY
Short Physical Performance Battery (SPPB)0 to 12 weeksBalance, Gait speed and time to sit and stand from a chair 5 times
Biochemical: Insulin Resistance (HOMAR-IR)0 to 12 weeks
Handgrip strength (kg)0 to 12 weeks
Biochemical: Myostatin0 to 12 weeks
Habitual Physical Activity0 to 12 weeksAccelerometer
Endurance (Six Minute Walk Test)0 to 12 weeks
Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery0 to 12 weeks
Salivary:Diurnal Cortisol0 to 12 weeks
Biochemical: Insulin-Like Growth Factor 1 (IGF-1)0 to 12 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026