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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

Canada1 site
  • McMaster University Medical Center

    Hamilton, Ontario, L8N 3Z5

Other trials in Canada

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:

  1. Healthy, recreationally active young males, placebo, n = 15
  2. Healthy, recreationally active young males, multi-nutrient supplement, n = 15
  3. Healthy, recreationally active young females, placebo, n = 15
  4. 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 groups in NCT06231069
Study groupRoleWhat they receive
Multi-nutrient supplementation during trainingExperimentalNot described
Receives: Dietary Supplement: Multi-nutrient supplement; Other: Exercise
Placebo during trainingPlacebo comparatorNot described
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in DXA-obtained muscle mass

    Pre to post change in DXA-obtained muscle mass (%)

    Measured: 12 weeks

  2. Percent change in DXA-obtained fat mass

    Pre to post change in DXA-obtained fat mass (%)

    Measured: 12 weeks

  3. 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

  4. Percent change in bodyweight

    Pre to post change in bodyweight (%)

    Measured: 12 weeks

  5. Percent change in body mass index

    Pre to post change in body mass index (%)

    Measured: 12 weeks

  6. Percent change in waist to hip ratio

    Pre to post change in waist to hip ratio (%)

    Measured: 12 weeks

Secondary outcomes (9)
  1. Percent change in slow muscle fiber areas

    Pre to post change in slow muscle fiber areas (%)

    Measured: 12 weeks

  2. Percent change in fast muscle fiber areas of quadriceps

    Pre to post change in fast muscle fiber areas of quadriceps (%)

    Measured: 12 weeks

  3. Percent change in quadriceps circumference

    Pre to post change in quadriceps circumference (%)

    Measured: 12 weeks

  4. Percent change in essential amino acid blood levels

    Pre to post change in venous essential amino acid blood levels (%)

    Measured: 12 weeks

  5. Percent change in inflammatory cytokine blood levels (interluekins)

    Pre to post change in venous inflammatory cytokine blood levels (interleukins) (%)

    Measured: 12 weeks

  6. Percent change in maximal leg extension strength

    Pre to post change in leg extension (%)

    Measured: 12 weeks

  7. Percent change in maximal leg press strength

    Pre to post change in maximal leg press strength (%)

    Measured: 12 weeks

  8. 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

  9. 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.

  1. First posted30 Jan 2024
  2. Study start20 Jan 2030 (estimated)
  3. Primary completion20 Apr 2030 (estimated)
  4. Study completion15 Dec 2030 (estimated)

Why it stopped: COVID 19: Study halted prior to enrollment of first participant.

Resources

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)
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

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.

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Clinical Trial NCT06231069 | AzTrials