SarcopeniaNCT03299972
Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men
A study testing Whey Protein and Resistance Exercise in people with Sarcopenia and Muscle Atrophy, run by Coventry University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Muscle Atrophy
- What is being tested?
- Whey Protein and Resistance Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Coventry University
Coventry, West Midlands, CV1 5FB
About this study
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
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.
Read the 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.
- Conditions
- Sarcopenia, Muscle Atrophy
- Being tested
- Whey Protein, Control, Resistance Exercise
- Keywords
- Sarcopenia, Resistance exercise, Protein
- Medical subject headings
- Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey ProteinDietary supplement
25 g whey protein supplementation twice daily (breakfast and lunch)
ControlDietary supplement
23.75 g maltodextrin twice daily (breakfast and lunch)
Resistance ExerciseOther
60 minutes of resistance exercise twice a week
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Control |
| Whey Protein | Experimental | Not described Receives: Dietary Supplement: Whey Protein |
| Resistance Exercise + Control | Experimental | Not described Receives: Dietary Supplement: Control; Other: Resistance Exercise |
| Resistance Exercise + Whey Protein | Experimental | Not described Receives: Dietary Supplement: Whey Protein; Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in components of 24-h energy expenditure and its components (kcal/d)
Measured by whole-room calorimetry
Measured: 0 to 12 weeks
Changes in body composition (kg)
Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis
Measured: 0 to 12 weeks
Changes in 24-h substrate oxidation (g/d)
Measured by whole-room calorimetry
Measured: 0 to 12 weeks
Secondary outcomes (13)
Biochemical: Appetite hormones
Ghrelin, leptin, and PYY
Measured: 0 to 12 weeks
Biochemical: Insulin Resistance (HOMAR-IR)
Measured: 0 to 12 weeks
Salivary:Diurnal Cortisol
Measured: 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
Measured: 0 to 12 weeks
Interstitial Glucose
24 Hour Continuous Glucose Monitoring
Measured: 0 to 12 weeks
Biochemical: Insulin-Like Growth Factor 1 (IGF-1)
Measured: 0 to 12 weeks
Isotonic Strength (kg) - Leg press and leg extension
Measured: 0 to 12 weeks
Short Physical Performance Battery (SPPB)
Balance, Gait speed and time to sit and stand from a chair 5 times
Measured: 0 to 12 weeks
Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery
Measured: 0 to 12 weeks
Handgrip strength (kg)
Measured: 0 to 12 weeks
Biochemical: Myostatin
Measured: 0 to 12 weeks
Habitual Physical Activity
Accelerometer
Measured: 0 to 12 weeks
Endurance (Six Minute Walk Test)
Measured: 0 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start27 Oct 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coventry University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust
- Responsible party
- Principal investigator, Corbin Griffen, Coventry University
- Investigators
- Derek Renshaw, PhD, Study director, Coventry UniversityJohn Hattersley, PhD, Study director, University Hosptials Coventry and Warwickshire NHS TrustMichael Duncan, PhD, Study director, Coventry UniversityCorbin Griffen, MSc, Principal investigator, Coventry University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299972
- Sponsor's protocol ID
- P59723
- Status last verified
- Jul 2019
- First submitted
- 11 Sep 2017
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griffen C, Cullen T, Hattersley J, Weickert MO, Dallaway A, Duncan M, Renshaw D. Effects of resistance exercise and whey protein supplementation on cognitive function in older men: secondary analysis of a randomised, double-blind, placebo-controlled trial. Exp Gerontol. 2024 Aug;193:112477. doi: 10.1016/j.exger.2024.112477. Epub 2024 Jun 6.
PubMed 38844183Griffen 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.
PubMed 37815091Griffen 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.
PubMed 34896568
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03299972
- Acronym / sponsor ID
- P59723
- Conditions
- Sarcopenia, Muscle Atrophy
- Keywords
- Sarcopenia, Resistance exercise, Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Coventry UniversityUniversity, hospital or other
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Control |
| Whey Protein | Experimental | Dietary Supplement: Whey Protein |
| Resistance Exercise + Control | Experimental | Dietary Supplement: Control, Other: Resistance Exercise |
| Resistance Exercise + Whey Protein | Experimental | Dietary Supplement: Whey Protein, Other: Resistance Exercise |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein25 g whey protein supplementation twice daily (breakfast and lunch) | Dietary supplement | Resistance Exercise + Whey Protein, Whey Protein |
| Control23.75 g maltodextrin twice daily (breakfast and lunch) | Dietary supplement | Control, Resistance Exercise + Control |
| Resistance Exercise60 minutes of resistance exercise twice a week | Other | Resistance Exercise + Control, Resistance Exercise + Whey Protein |
Primary outcome
Changes in components of 24-h energy expenditure and its components (kcal/d)
Time frame: 0 to 12 weeks
Measured by whole-room calorimetry
Changes in body composition (kg)
Time frame: 0 to 12 weeks
Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis
Changes in 24-h substrate oxidation (g/d)
Time frame: 0 to 12 weeks
Measured by whole-room calorimetry
13 secondary outcomes
Biochemical: Appetite hormones
Time frame: 0 to 12 weeks
Biochemical: Insulin Resistance (HOMAR-IR)
Time frame: 0 to 12 weeks
Salivary:Diurnal Cortisol
Time frame: 0 to 12 weeks
Biochemical: Inflammtion
Time frame: 0 to 12 weeks
Interstitial Glucose
Time frame: 0 to 12 weeks
Biochemical: Insulin-Like Growth Factor 1 (IGF-1)
Time frame: 0 to 12 weeks
Isotonic Strength (kg) - Leg press and leg extension
Time frame: 0 to 12 weeks
Short Physical Performance Battery (SPPB)
Time frame: 0 to 12 weeks
Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery
Time frame: 0 to 12 weeks
Handgrip strength (kg)
Time frame: 0 to 12 weeks
Biochemical: Myostatin
Time frame: 0 to 12 weeks
Habitual Physical Activity
Time frame: 0 to 12 weeks
Endurance (Six Minute Walk Test)
Time frame: 0 to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Derived from this study: PubMed 38844183Griffen C, Cullen T, Hattersley J, Weickert MO, Dallaway A, Duncan M, Renshaw D. Effects of resistance exercise and whey protein supplementation on cognitive function in older men: secondary analysis of a randomised, double-blind, placebo-controlled trial. Exp Gerontol. 2024 Aug;193:112477. doi: 10.1016/j.exger.2024.112477. Epub 2024 Jun 6.
- Derived from this study: PubMed 37815091Griffen 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.
- Derived from this study: PubMed 34896568Griffen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Renshaw, PhD study director
Coventry University
John Hattersley, PhD study director
University Hosptials Coventry and Warwickshire NHS Trust
Michael Duncan, PhD study director
Coventry University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein and Resistance Exercise in people with Sarcopenia and Muscle Atrophy, run by Coventry University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in components of 24-h energy expenditure and its components (kcal/d) (time frame: 0 to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03299972, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.