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
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedStudy Start
First participant enrolled
October 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedJuly 26, 2019
July 1, 2019
1.7 years
September 11, 2017
July 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (13)
Biochemical: Appetite hormones
0 to 12 weeks
Biochemical: Insulin Resistance (HOMAR-IR)
0 to 12 weeks
Salivary:Diurnal Cortisol
0 to 12 weeks
Biochemical: Inflammtion
0 to 12 weeks
Interstitial Glucose
0 to 12 weeks
- +8 more secondary outcomes
Study Arms (4)
Control
PLACEBO COMPARATORWhey Protein
EXPERIMENTALResistance Exercise + Control
EXPERIMENTALResistance Exercise + Whey Protein
EXPERIMENTALInterventions
25 g whey protein supplementation twice daily (breakfast and lunch)
23.75 g maltodextrin twice daily (breakfast and lunch)
60 minutes of resistance exercise twice a week
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Coventry University
Coventry, West Midlands, CV1 5FB, United Kingdom
Related Publications (2)
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.
PMID: 37815091DERIVEDGriffen 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.
PMID: 34896568DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
September 11, 2017
First Posted
October 3, 2017
Study Start
October 27, 2017
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
July 26, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share