AgingNCT02281331
Optimal Exercise Training and Nutrition Supplementation in Older Men
A study testing Supplement in people with Aging, run by McMaster University at 1 site in Canada.
Trial summary
As we age we tend to lose muscle mass and strength. These losses contribute to the increased incidence of falls and fractures, metabolic diseases such as type 2 diabetes, loss of independence and reduced quality of life in the elderly. Read more about this study
- Who is it for?
- Ages 60 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2014to 1 May 2018
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary (no participation in a structured exercise training program in past 6 months)
- BMI between 18.5-30.0 kg/m2
- Weight stable for past 6 months
- Normal resting blood pressure, or stage I hypertension
Who cannot join
- Smoking
- Use of simvastatin or atorvastatin
- Use of non-steroidal anti-inflammatory drugs
- Injuries that prevent safe-participation in an exercise training program
- Prescription blood thinners
- Diabetes or other metabolic disorders
- Cardiac or gastro-intestinal problems
- Infectious disease or cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of a Combined Resistance and High-intensity Interval Exercise Training Program, Along With Nutritional Supplementation, on Strength and Physical Function in Older Men
As we age we tend to lose muscle mass and strength. These losses contribute to the increased incidence of falls and fractures, metabolic diseases such as type 2 diabetes, loss of independence and reduced quality of life in the elderly. As the number of seniors increases worldwide, it is becoming more and more important to develop strategies to counteract this loss of muscle mass and strength, and promote healthy aging. Fortunately, relatively simple lifestyle modifications are the most potent defense strategies. Exercises such as weight lifting and high-intensity interval exercise (HIIT), which consists of short, repeated bouts of vigorous aerobic exercise interspersed with period of rest, are the most effective in promoting gains in muscle mass and strength. Additionally, components of foods like whey (a protein found in milk), creatine (found in meat), calcium and vitamin D have been shown to independently increase strength. In this study, we are looking to determine how much we can increase muscle strength in older men who are put on an 12 week exercise training program that combines weight lifting and HIIT, and who consume a daily supplement that contains whey protein, creatine, calcium and vitamin D.
Read the detailed description
Please see other documentation.
- Conditions
- Aging
- Being tested
- Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
supplement/placebo plus exercise training
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Active comparator | Each day, participants in this group will receive a supplement that provides a total of protein, creatine monohydrate, calcium, vitamin D and carbohydrate. This supplement will be provided to participants in beverage format, twice daily. Receives: Dietary Supplement: Supplement |
| Placebo | Placebo comparator | The placebo will provide participants with maltodextrin (carbohydrate) and sucrose. Receives: Dietary Supplement: Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
DXA, ultrasound
Measured: 12 weeks
Secondary outcomes (4)
Muscle protein synthesis
The incorporation of a stable isotope (deuterium) into muscle tissue will allow for the determination of fractional synthetic rate, which is indicative of muscle protein synthesis.
Measured: 12 weeks
Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain
Histochemical methods will be used to determine how the supplement and training affect muscle growth and regenerative capacity, specifically the behaviour of satellite cells.
Measured: 12 weeks
Glycemic control
Oral glucose tolerance test
Measured: 12 weeks
Cognitive function
Questionnaires and simple computer-based identification, reaction time and memory tasks.
Measured: 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 Nov 2014 (estimated)
- Study start1 Oct 2014
- Primary completion1 Dec 2016
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281331
- Sponsor's protocol ID
- REB 14-677
- Status last verified
- Aug 2018
- First submitted
- 8 Oct 2014
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bell KE, Fang H, Snijders T, Allison DJ, Zulyniak MA, Chabowski A, Parise G, Phillips SM, Heisz JJ. A Multi-Ingredient Nutritional Supplement in Combination With Resistance Exercise and High-Intensity Interval Training Improves Cognitive Function and Increases N-3 Index in Healthy Older Men: A Randomized Controlled Trial. Front Aging Neurosci. 2019 May 9;11:107. doi: 10.3389/fnagi.2019.00107. eCollection 2019.
PubMed 31143111Bell KE, Brook MS, Snijders T, Kumbhare D, Parise G, Smith K, Atherton PJ, Phillips SM. Integrated Myofibrillar Protein Synthesis in Recovery From Unaccustomed and Accustomed Resistance Exercise With and Without Multi-ingredient Supplementation in Overweight Older Men. Front Nutr. 2019 Apr 11;6:40. doi: 10.3389/fnut.2019.00040. eCollection 2019.
PubMed 31032258Snijders T, Bell KE, Nederveen JP, Saddler NI, Mazara N, Kumbhare DA, Phillips SM, Parise G. Ingestion of a Multi-Ingredient Supplement Does Not Alter Exercise-Induced Satellite Cell Responses in Older Men. J Nutr. 2018 Jun 1;148(6):891-899. doi: 10.1093/jn/nxy063.
PubMed 29878269Bell KE, Snijders T, Zulyniak M, Kumbhare D, Parise G, Chabowski A, Phillips SM. A whey protein-based multi-ingredient nutritional supplement stimulates gains in lean body mass and strength in healthy older men: A randomized controlled trial. PLoS One. 2017 Jul 18;12(7):e0181387. doi: 10.1371/journal.pone.0181387. eCollection 2017.
PubMed 28719669
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of a Combined Resistance and High-intensity Interval Exercise Training Program, Along With Nutritional Supplementation, on Strength and Physical Function in Older Men
- ClinicalTrials.gov ID
- NCT02281331
- Acronym / sponsor ID
- REB 14-677
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 3 Nov 2014 (estimated)
- 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.
As we age we tend to lose muscle mass and strength. These losses contribute to the increased incidence of falls and fractures, metabolic diseases such as type 2 diabetes, loss of independence and reduced quality of life in the elderly. As the number of seniors increases worldwide, it is becoming more and more important to develop strategies to counteract this loss of muscle mass and strength, and promote healthy aging. Fortunately, relatively simple lifestyle modifications are the most potent defense strategies. Exercises such as weight lifting and high-intensity interval exercise (HIIT), which consists of short, repeated bouts of vigorous aerobic exercise interspersed with period of rest, are the most effective in promoting gains in muscle mass and strength. Additionally, components of foods like whey (a protein found in milk), creatine (found in meat), calcium and vitamin D have been shown to independently increase strength. In this study, we are looking to determine how much we can increase muscle strength in older men who are put on an 12 week exercise training program that combines weight lifting and HIIT, and who consume a daily supplement that contains whey protein, creatine, calcium and vitamin D.
Detailed description
Please see other documentation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement | Active comparator | Dietary Supplement: SupplementEach day, participants in this group will receive a supplement that provides a total of protein, creatine monohydrate, calcium, vitamin D and carbohydrate. This supplement will be provided to participants in beverage format, twice daily. |
| Placebo | Placebo comparator | Dietary Supplement: SupplementThe placebo will provide participants with maltodextrin (carbohydrate) and sucrose. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sedentary (no participation in a structured exercise training program in past 6 months)
- BMI between 18.5-30.0 kg/m2
- Weight stable for past 6 months
- Normal resting blood pressure, or stage I hypertension
Key exclusion criteria (8 listed)
- Smoking
- Use of simvastatin or atorvastatin
- Use of non-steroidal anti-inflammatory drugs
- Injuries that prevent safe-participation in an exercise training program
- Prescription blood thinners
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 |
|---|---|---|
| Supplementsupplement/placebo plus exercise training | Dietary supplement | Placebo, Supplement |
Primary outcome
Muscle mass
Time frame: 12 weeks
DXA, ultrasound
4 secondary outcomes
Muscle protein synthesis
Time frame: 12 weeks
Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain
Time frame: 12 weeks
Glycemic control
Time frame: 12 weeks
Cognitive function
Time frame: 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 16 Aug 2018.
- Derived from this study: PubMed 31143111Bell KE, Fang H, Snijders T, Allison DJ, Zulyniak MA, Chabowski A, Parise G, Phillips SM, Heisz JJ. A Multi-Ingredient Nutritional Supplement in Combination With Resistance Exercise and High-Intensity Interval Training Improves Cognitive Function and Increases N-3 Index in Healthy Older Men: A Randomized Controlled Trial. Front Aging Neurosci. 2019 May 9;11:107. doi: 10.3389/fnagi.2019.00107. eCollection 2019.
- Derived from this study: PubMed 31032258Bell KE, Brook MS, Snijders T, Kumbhare D, Parise G, Smith K, Atherton PJ, Phillips SM. Integrated Myofibrillar Protein Synthesis in Recovery From Unaccustomed and Accustomed Resistance Exercise With and Without Multi-ingredient Supplementation in Overweight Older Men. Front Nutr. 2019 Apr 11;6:40. doi: 10.3389/fnut.2019.00040. eCollection 2019.
- Derived from this study: PubMed 29878269Snijders T, Bell KE, Nederveen JP, Saddler NI, Mazara N, Kumbhare DA, Phillips SM, Parise G. Ingestion of a Multi-Ingredient Supplement Does Not Alter Exercise-Induced Satellite Cell Responses in Older Men. J Nutr. 2018 Jun 1;148(6):891-899. doi: 10.1093/jn/nxy063.
- Derived from this study: PubMed 28719669Bell KE, Snijders T, Zulyniak M, Kumbhare D, Parise G, Chabowski A, Phillips SM. A whey protein-based multi-ingredient nutritional supplement stimulates gains in lean body mass and strength in healthy older men: A randomized controlled trial. PLoS One. 2017 Jul 18;12(7):e0181387. doi: 10.1371/journal.pone.0181387. eCollection 2017.
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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.
Stuart Phillips, PhD principal investigator
McMaster 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 Supplement in people with Aging, run by McMaster University at 1 site in Canada.
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 8 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 16 Aug 2018. 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 Canada. 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?
Muscle mass (time frame: 12 weeks). 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 NCT02281331, which also lists 4 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 16 Aug 2018.