Clinical trial NCT03299972: Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Muscle Atrophy
Keywords: Sarcopenia
Resistance exercise
Protein
Lead sponsor: Coventry University
Sponsor class: OTHER
Collaborators: name: University Hospitals Coventry and Warwickshire NHS Trust
First posted: 2017-10-03
Enrollment: 39
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in components of 24-h energy expenditure and its components (kcal/d)
timeFrame: 0 to 12 weeks
measure: Changes in body composition (kg)
timeFrame: 0 to 12 weeks
measure: Changes in 24-h substrate oxidation (g/d)
timeFrame: 0 to 12 weeks
Secondary outcomes:
measure: Biochemical: Appetite hormones
timeFrame: 0 to 12 weeks
measure: Biochemical: Insulin Resistance (HOMAR-IR)
timeFrame: 0 to 12 weeks
measure: Salivary:Diurnal Cortisol
timeFrame: 0 to 12 weeks
measure: Biochemical: Inflammtion
timeFrame: 0 to 12 weeks
measure: Interstitial Glucose
timeFrame: 0 to 12 weeks
measure: Biochemical: Insulin-Like Growth Factor 1 (IGF-1)
timeFrame: 0 to 12 weeks
measure: Isotonic Strength (kg) - Leg press and leg extension
timeFrame: 0 to 12 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: 0 to 12 weeks
measure: Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery
timeFrame: 0 to 12 weeks
measure: Handgrip strength (kg)
timeFrame: 0 to 12 weeks
measure: Biochemical: Myostatin
timeFrame: 0 to 12 weeks
measure: Habitual Physical Activity
timeFrame: 0 to 12 weeks
measure: Endurance (Six Minute Walk Test)
timeFrame: 0 to 12 weeks
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: Coventry University
state: West Midlands
Study officials:
affiliation: Coventry University
name: Derek Renshaw, PhD
role: STUDY_DIRECTOR
affiliation: University Hosptials Coventry and Warwickshire NHS Trust
name: John Hattersley, PhD
role: STUDY_DIRECTOR
affiliation: Coventry University
name: Michael Duncan, PhD
role: STUDY_DIRECTOR
affiliation: Coventry University
name: Corbin Griffen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.