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

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299972
• Other study ID #: P59723
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: Coventry University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Muscle Atrophy
• Muscular Atrophy
• Sarcopenia

Intervention

Dietary Supplement:
• Whey Protein
25 g whey protein supplementation twice daily (breakfast and lunch)
• Control
23.75 g maltodextrin twice daily (breakfast and lunch)

Other:
• Resistance Exercise
60 minutes of resistance exercise twice a week

Locations

Country	Name	City	State
United Kingdom	Coventry University	Coventry	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
Coventry University	University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in components of 24-h energy expenditure and its components (kcal/d)	Measured by whole-room calorimetry	0 to 12 weeks
Primary	Changes in body composition (kg)	Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis	0 to 12 weeks
Primary	Changes in 24-h substrate oxidation (g/d)	Measured by whole-room calorimetry	0 to 12 weeks
Secondary	Biochemical: Appetite hormones	Ghrelin, leptin, and PYY	0 to 12 weeks
Secondary	Biochemical: Insulin Resistance (HOMAR-IR)		0 to 12 weeks
Secondary	Salivary:Diurnal Cortisol		0 to 12 weeks
Secondary	Biochemical: Inflammtion	Tumor necrosis factor alpha (TNF-a), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), Annexin A1	0 to 12 weeks
Secondary	Interstitial Glucose	24 Hour Continuous Glucose Monitoring	0 to 12 weeks
Secondary	Biochemical: Insulin-Like Growth Factor 1 (IGF-1)		0 to 12 weeks
Secondary	Isotonic Strength (kg) - Leg press and leg extension		0 to 12 weeks
Secondary	Short Physical Performance Battery (SPPB)	Balance, Gait speed and time to sit and stand from a chair 5 times	0 to 12 weeks
Secondary	Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery		0 to 12 weeks
Secondary	Handgrip strength (kg)		0 to 12 weeks
Secondary	Biochemical: Myostatin		0 to 12 weeks
Secondary	Habitual Physical Activity	Accelerometer	0 to 12 weeks
Secondary	Endurance (Six Minute Walk Test)		0 to 12 weeks