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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Muscle Atrophy
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: Whey Protein; Other: Resistance Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV1 5FB
      • Coventry University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Dietary supplement: Control; 23.75 g maltodextrin twice daily (breakfast and lunch)
Experimental: Whey Protein	Dietary supplement: Whey Protein; 25 g whey protein supplementation twice daily (breakfast and lunch)
Experimental: Resistance Exercise + Control	Dietary supplement: Control; 23.75 g maltodextrin twice daily (breakfast and lunch); Other: Resistance Exercise; 60 minutes of resistance exercise twice a week
Experimental: Resistance Exercise + Whey Protein	Dietary supplement: Whey Protein; 25 g whey protein supplementation twice daily (breakfast and lunch); Other: Resistance Exercise; 60 minutes of resistance exercise twice a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical: Appetite hormones	Ghrelin, leptin, and PYY	0 to 12 weeks
Biochemical: Insulin Resistance (HOMAR-IR)		0 to 12 weeks
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

Collaborators and Investigators

• Sponsor: Coventry University
• Collaborators: University Hospitals Coventry and Warwickshire NHS Trust
• Investigators: Study Director: Derek Renshaw, PhD, Coventry University; Study Director: John Hattersley, PhD, University Hosptials Coventry and Warwickshire NHS Trust; Study Director: Michael Duncan, PhD, Coventry University; Principal Investigator: Corbin Griffen, MSc, Coventry University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Sarcopenia; Protein; Resistance exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Sarcopenia; Muscular Atrophy
• Other Study ID Numbers: P59723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes