SarcopeniaNCT06231069
Mixed Exercise Training and Novel Multi-Nutrient Supplementation in Young Adults
A study testing Multi-nutrient supplement and Exercise in people with Sarcopenia, run by McMaster University at 1 site in Canada.
Trial summary
This study aims to elucidate the effects of 12 weeks of novel multi-nutrient supplementation combined with mixed aerobic/resistance exercise training on skeletal muscle function in young adults. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Multi-nutrient supplement and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2030to 15 Dec 2030
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smoking
- non-diabetic
- apparently healthy
- minimally recreationally active
- males and females aged 18-30 years
Who cannot join
- pregnancy
- breast feeding
- smoking
- obesity
- diabetes mellitus
- cardiovascular disease (recent myocardial infarction (≤ 6 months)
Show all 23Show fewer
- hypertension requiring more than 2 medications
- congestive heart failure requiring more than one medication,
- renal disease (creatinine > 130),
- previous stroke with residual hemiparesis,
- active musculoskeletal injuries and/or severe osteoarthritis,
- significant weight loss in the 3-month period prior to the study,
- vegan diet,
- dairy protein allergy,
- muscular dystrophy,
- severe peripheral neuropathy,
- severe osteoporosis,
- use of medications known to affect protein metabolism (i.e. corticosteroids),
- inability to consent,
- chronic obstructive pulmonary disease (FVC or FEV1 < 70% of age predicted mean value),
- asthma requiring more than two medications.
- Subjects on supplements will be considered on a case-by-case basis, but they will be asked to refrain from intake for at least 2 weeks prior to partaking in this study.
- While adverse events are not anticipated, participants will be asked to disclose if they are using supplements that may have negative/interactive effects with our study products. Each participant's list of medications will also be checked for potential interactive side-effects with our supplements; however, the individual doses have specifically been chosen to be at the low end to minimize the likelihood of such interactions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mixed Exercise Training and a Novel Multi-Nutrient Supplement on Muscle Fitness in Young Adults
This study aims to elucidate the effects of 12 weeks of novel multi-nutrient supplementation combined with mixed aerobic/resistance exercise training on skeletal muscle function in young adults.
It is hypothesized that multi-nutrient supplementation and mixed aerobic/resistance exercise training (AET/RET) will have interactive effects on muscle fitness.
Read the detailed description
Sedentarism is highly prevalent, world-wide, and predisposes for chronic disease and premature death. Conversely, regular physical activity (PA) protects against cardiovascular disease (CVD), deterioration of the musculoskeletal system, cancer, obesity, type 2 diabetes, depression, anxiety, and neurodegeneration. Similar to most adults in the world, the majority of Canadians are not meeting the minimal PA guidelines, with total health care cost attributed to physical inactivity estimated to be $6.8 billion. Therefore, it is imperative to develop strategies to increase PA rates across the general population (young to old) to alleviate the global burden of chronic disease. These strategies may include large-scale, societal interventions that incentivize daily PA/sports participation (mainly access and affordability), educational efforts, and continued support of exercise science research. Specifically, research on exercise modes that are time-saving but equally (or more) effective as traditional training modes is warranted. More studies are also needed on nutritional supplementation (safety and efficacy), particularly in conjunction with various exercise modes for optimization of health and performance.
In this randomized, double-blind, placebo-controlled clinical trial, the aim is to elucidate the effects of 12 weeks of novel multi-nutrient supplementation combined with mixed aerobic/resistance exercise training on skeletal muscle function in young adults. Following recruitment, participants will be stratified and randomized into one of four groups:
- Healthy, recreationally active young males, placebo, n = 15
- Healthy, recreationally active young males, multi-nutrient supplement, n = 15
- Healthy, recreationally active young females, placebo, n = 15
- Healthy, recreationally active young females, multi-nutrient supplement, n = 15
Thereafter, subjects will undergo 12 weeks of a mixed AET and RET, three days per week, approximately 1 hour per training session. The AET will consist of cycle ergometry for 20 min at 75% HRmax, corresponding to ~65% VO2max (Monark cardio care 827E). As the aerobic fitness of the subjects are progressively enhanced, the cadence RPM and/or resistance of the bike will be increased to elicit 65% VO2max. This work rate, corresponding to ~75% HRmax, will be monitored by the subjects wearing a heart rate monitor around their chests (Polar). Immediately following the AET, the subjects will perform a lower body resistance exercise program consisting of four traditional resistance exercises starting at 65% of 1-RM (Cybex Eagle). Specifically, the RET program will consist of leg press, seated calf extension, knee extension, and hamstring curls, to be performed at 65% 1-RM for 4 x 15 repetitions initially, and thereafter progressively increased throughout the 12-week intervention period to 85% 1-RM for 4 x 8 repetitions. Resistance will be increased with ~2-10% in load when the individual can perform the current workload for one or two repetitions over the desired number on two consecutive training sessions. Prior to beginning the research coordinator will meet with participants and teach them how to properly perform exercises (familiarization session).
Concurrently, participants will be asked to consume 7 servings of a multi-nutrient supplement per week with 200 mL water. The supplement consists of mixed milk proteins, creatine, N-3 PUFAs, and vitamin D at levels previously shown to stimulate muscle protein synthesis. On training days, the compound will be consumed immediately after the training session under the supervision of a study coordinator. On the remaining four days, subjects will consume 1 serving prior to breakfast, which is regarded as the least protein-rich meal of the day. In order to monitor 'at-home' compliance, the subjects will be instructed to record their daily intake in a supplement log.
- Conditions
- Sarcopenia
- Being tested
- Multi-nutrient supplement, Exercise
- Keywords
- Muscle
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-nutrient supplementDietary supplement
12 weeks of supplement intake of milk proteins, N-3 PUFAs, creatine, and vitamin D at levels previously shown to augment muscle protein synthesis in young individuals.
ExerciseOther
12 weeks of short-duration mixed endurance and resistance exercise.
| Study group | Role | What they receive |
|---|---|---|
| Multi-nutrient supplementation during training | Experimental | Not described Receives: Dietary Supplement: Multi-nutrient supplement; Other: Exercise |
| Placebo during training | Placebo comparator | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in DXA-obtained muscle mass
Pre to post change in DXA-obtained muscle mass (%)
Measured: 12 weeks
Percent change in DXA-obtained fat mass
Pre to post change in DXA-obtained fat mass (%)
Measured: 12 weeks
Percent change in DXA-obtained muscle mass to fat mass ratio
Pre to post change in DXA-obtained muscle mass to fat mass ratio (%)
Measured: 12 weeks
Percent change in bodyweight
Pre to post change in bodyweight (%)
Measured: 12 weeks
Percent change in body mass index
Pre to post change in body mass index (%)
Measured: 12 weeks
Percent change in waist to hip ratio
Pre to post change in waist to hip ratio (%)
Measured: 12 weeks
Secondary outcomes (9)
Percent change in slow muscle fiber areas
Pre to post change in slow muscle fiber areas (%)
Measured: 12 weeks
Percent change in fast muscle fiber areas of quadriceps
Pre to post change in fast muscle fiber areas of quadriceps (%)
Measured: 12 weeks
Percent change in quadriceps circumference
Pre to post change in quadriceps circumference (%)
Measured: 12 weeks
Percent change in essential amino acid blood levels
Pre to post change in venous essential amino acid blood levels (%)
Measured: 12 weeks
Percent change in inflammatory cytokine blood levels (interluekins)
Pre to post change in venous inflammatory cytokine blood levels (interleukins) (%)
Measured: 12 weeks
Percent change in maximal leg extension strength
Pre to post change in leg extension (%)
Measured: 12 weeks
Percent change in maximal leg press strength
Pre to post change in maximal leg press strength (%)
Measured: 12 weeks
Percent change in number of repetitions at 60% maximum in leg press
Pre to post change in number of repetitions at 60% maximum in leg press (%)
Measured: 12 weeks
Percent change in maximal aerobic capacity
Pre to post change in maximal aerobic capacity (%)
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 posted30 Jan 2024
- Study start20 Jan 2030 (estimated)
- Primary completion20 Apr 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Why it stopped: COVID 19: Study halted prior to enrollment of first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is a randomized, double-blind, placebo-controlled 12-week mixed training and supplementation study (placebo vs. active supplement), with data collection occurring at several different time-points (pre, mid, and post) in young males and females (18-30 years of age).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Tarnopolsky, McMaster University
- Investigators
- Mark A Tarnopolsky, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231069
- Sponsor's protocol ID
- 7405
- Status last verified
- Jan 2024
- First submitted
- 12 Jul 2019
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mixed Exercise Training and a Novel Multi-Nutrient Supplement on Muscle Fitness in Young Adults
- ClinicalTrials.gov ID
- NCT06231069
- Acronym / sponsor ID
- 7405
- Conditions
- Sarcopenia
- Keywords
- Muscle
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID 19: Study halted prior to enrollment of first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 20 Jan 2030 (estimated)
- Primary completion
- 20 Apr 2030 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 30 Jan 2024 (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.
This study aims to elucidate the effects of 12 weeks of novel multi-nutrient supplementation combined with mixed aerobic/resistance exercise training on skeletal muscle function in young adults.
It is hypothesized that multi-nutrient supplementation and mixed aerobic/resistance exercise training (AET/RET) will have interactive effects on muscle fitness.
Detailed description
Sedentarism is highly prevalent, world-wide, and predisposes for chronic disease and premature death. Conversely, regular physical activity (PA) protects against cardiovascular disease (CVD), deterioration of the musculoskeletal system, cancer, obesity, type 2 diabetes, depression, anxiety, and neurodegeneration. Similar to most adults in the world, the majority of Canadians are not meeting the minimal PA guidelines, with total health care cost attributed to physical inactivity estimated to be $6.8 billion. Therefore, it is imperative to develop strategies to increase PA rates across the general population (young to old) to alleviate the global burden of chronic disease. These strategies may include large-scale, societal interventions that incentivize daily PA/sports participation (mainly access and affordability), educational efforts, and continued support of exercise science research. Specifically, research on exercise modes that are time-saving but equally (or more) effective as traditional training modes is warranted. More studies are also needed on nutritional supplementation (safety and efficacy), particularly in conjunction with various exercise modes for optimization of health and performance.
In this randomized, double-blind, placebo-controlled clinical trial, the aim is to elucidate the effects of 12 weeks of novel multi-nutrient supplementation combined with mixed aerobic/resistance exercise training on skeletal muscle function in young adults. Following recruitment, participants will be stratified and randomized into one of four groups:
- Healthy, recreationally active young males, placebo, n = 15
- Healthy, recreationally active young males, multi-nutrient supplement, n = 15
- Healthy, recreationally active young females, placebo, n = 15
- Healthy, recreationally active young females, multi-nutrient supplement, n = 15
Thereafter, subjects will undergo 12 weeks of a mixed AET and RET, three days per week, approximately 1 hour per training session. The AET will consist of cycle ergometry for 20 min at 75% HRmax, corresponding to ~65% VO2max (Monark cardio care 827E). As the aerobic fitness of the subjects are progressively enhanced, the cadence RPM and/or resistance of the bike will be increased to elicit 65% VO2max. This work rate, corresponding to ~75% HRmax, will be monitored by the subjects wearing a heart rate monitor around their chests (Polar). Immediately following the AET, the subjects will perform a lower body resistance exercise program consisting of four traditional resistance exercises starting at 65% of 1-RM (Cybex Eagle). Specifically, the RET program will consist of leg press, seated calf extension, knee extension, and hamstring curls, to be performed at 65% 1-RM for 4 x 15 repetitions initially, and thereafter progressively increased throughout the 12-week intervention period to 85% 1-RM for 4 x 8 repetitions. Resistance will be increased with ~2-10% in load when the individual can perform the current workload for one or two repetitions over the desired number on two consecutive training sessions. Prior to beginning the research coordinator will meet with participants and teach them how to properly perform exercises (familiarization session).
Concurrently, participants will be asked to consume 7 servings of a multi-nutrient supplement per week with 200 mL water. The supplement consists of mixed milk proteins, creatine, N-3 PUFAs, and vitamin D at levels previously shown to stimulate muscle protein synthesis. On training days, the compound will be consumed immediately after the training session under the supervision of a study coordinator. On the remaining four days, subjects will consume 1 serving prior to breakfast, which is regarded as the least protein-rich meal of the day. In order to monitor 'at-home' compliance, the subjects will be instructed to record their daily intake in a supplement log.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study is a randomized, double-blind, placebo-controlled 12-week mixed training and supplementation study (placebo vs. active supplement), with data collection occurring at several different time-points (pre, mid, and post) in young males and females (18-30 years of age).
| Arm | Type | Receives |
|---|---|---|
| Multi-nutrient supplementation during training | Experimental | Dietary Supplement: Multi-nutrient supplement, Other: Exercise |
| Placebo during training | Placebo comparator | Other: Exercise |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- non-smoking
- non-diabetic
- apparently healthy
- minimally recreationally active
- males and females aged 18-30 years
Key exclusion criteria (23 listed)
- pregnancy
- breast feeding
- smoking
- obesity
- diabetes mellitus
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 |
|---|---|---|
| Multi-nutrient supplement12 weeks of supplement intake of milk proteins, N-3 PUFAs, creatine, and vitamin D at levels previously shown to augment muscle protein synthesis in young individuals. | Dietary supplement | Multi-nutrient supplementation during training |
| Exercise12 weeks of short-duration mixed endurance and resistance exercise. | Other | Multi-nutrient supplementation during training, Placebo during training |
Primary outcome
Percent change in DXA-obtained muscle mass
Time frame: 12 weeks
Pre to post change in DXA-obtained muscle mass (%)
Percent change in DXA-obtained fat mass
Time frame: 12 weeks
Pre to post change in DXA-obtained fat mass (%)
Percent change in DXA-obtained muscle mass to fat mass ratio
Time frame: 12 weeks
Pre to post change in DXA-obtained muscle mass to fat mass ratio (%)
Percent change in bodyweight
Time frame: 12 weeks
Pre to post change in bodyweight (%)
Percent change in body mass index
Time frame: 12 weeks
Pre to post change in body mass index (%)
Percent change in waist to hip ratio
Time frame: 12 weeks
Pre to post change in waist to hip ratio (%)
9 secondary outcomes
Percent change in slow muscle fiber areas
Time frame: 12 weeks
Percent change in fast muscle fiber areas of quadriceps
Time frame: 12 weeks
Percent change in quadriceps circumference
Time frame: 12 weeks
Percent change in essential amino acid blood levels
Time frame: 12 weeks
Percent change in inflammatory cytokine blood levels (interluekins)
Time frame: 12 weeks
Percent change in maximal leg extension strength
Time frame: 12 weeks
Percent change in maximal leg press strength
Time frame: 12 weeks
Percent change in number of repetitions at 60% maximum in leg press
Time frame: 12 weeks
Percent change in maximal aerobic capacity
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Not yet recruitingObservational study
Sarcopenia Risk in Obese T2DM Patients
Sarcopenia, Obesity Type 2 Diabetes Mellitus
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
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.
Mark A Tarnopolsky, MD, 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 Multi-nutrient supplement and Exercise in people with Sarcopenia, 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 5 inclusion and 23 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: withdrawn, as of the sponsor's last update on 30 Jan 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percent change in DXA-obtained muscle mass (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2024.