HypertrophyD2O-MPSNCT04256343
D2O Dosing Strategies to Assess Muscle Protein Synthesis
A study testing Deuterium Oxide (D2O) Dose in people with Hypertrophy, run by McMaster University.
Trial summary
Skeletal muscle mass is regulated by the balance of muscle protein synthesis (MPS) and muscle protein breakdown (MPB). MPS is sensitive to exogenous stimuli, particularly exercise and protein ingestion. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophy
- What is being tested?
- Deuterium Oxide (D2O) Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 Jun 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, between the ages of 18 - 35 years (inclusive)
- Have a body mass index (BMI) between 18-30 kg·m2 (inclusive)
- Be in general good health as assessed by a general health questionnaire
- Non-smoking
- Willing and able to provide informed consent
Who cannot join
- Ingestion of deuterated water (D2O) in the previous ~6 months.
- Routine/daily usage of non-steroidal anti-inflammatory drugs (NSAIDS, prescription use or daily use of over the counter medication), use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs) within 45 days prior to screening.
- Use of tobacco or related products.
- Veganism or vegetarianism
- Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements.
- Use assistive walking devices (e.g., cane or walker)
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- History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
- Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives.
- Any cachexia-related condition (e.g., relating to cancer, tuberculosis or human immunodeficiency virus infection and acquired immune deficiency syndrome) or any genetic muscle diseases or disorders
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
- Hypersensitivity or known allergy to any of the components in the test formulations.
- Excessive alcohol consumption (>21 units/week)
- History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy (up to 81mg of baby aspirin per day taken as a prophylactic is permitted).
- History of statin myalgia.
- Personal or family history of clotting disorder or deep vein thrombosis.
About this study
Official title: The Sensitivity of Differing D2O Dosing Strategies and Mass Spectrometry-based Analytical Techniques to Determine Rates of Muscle Protein Synthesis in Young Men and Women
Skeletal muscle mass is regulated by the balance of muscle protein synthesis (MPS) and muscle protein breakdown (MPB). MPS is sensitive to exogenous stimuli, particularly exercise and protein ingestion. Much of what the investigators currently know about the impact of exercise and protein feeding on MPS has been derived from acute stable isotopic tracers in a controlled laboratory setting. However, recently, the field of skeletal muscle protein metabolism has moved towards the use of deuterium oxide (deuterated water (D2O)) to measure MPS. The ease of administration and the scope to measure turnover in a range of substrates whilst negating the need for strictly controlled laboratory settings makes D2O the ideal candidate to provide a more holistic view of in vivo skeletal muscle metabolism.
Read the detailed description
Currently, there is a lack of consensus amongst researchers regarding the dosing strategies of D2O provision for measuring fraction-specific (myofibrillar, mitochondrial and sarcoplasmic) protein synthetic rates. In addition, the analytical equipment (i.e., mass spectrometers) required to carry out the analysis of skeletal muscle-bound alanine are technically challenging, offer varying degrees of sensitivity that may drastically influence outcome measures and the expense of analysis differs greatly between the type of mass spectrometer required.Thus, this study will employ different D2O doses to assess basal and exercise plus protein feeding-induced rates of acute and integrated MPS in healthy young men and women. This will provide researchers with insight into the amount of D2O required to accurately assess MPS and the sensitivity of the analytical machine employed.
- Conditions
- Hypertrophy
- Being tested
- Deuterium Oxide (D2O) Dose
- Keywords
- Muscle, Muscle protein synthesis, Deuterium
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterium Oxide (D2O) DoseOther
1 of 3 differing deuterium oxide (D2O) doses will provided to each of the participants to be consumed daily to assess muscle protein synthesis.
| Study group | Role | What they receive |
|---|---|---|
| D2O Dose 1 | Experimental | Lower dose of D2O for MPS Receives: Other: Deuterium Oxide (D2O) Dose |
| D2O Dose 2 | Experimental | Moderate dose of D2O MPS Receives: Other: Deuterium Oxide (D2O) Dose |
| D2O Dose 3 | Experimental | Higher dose of D2O for MPS Receives: Other: Deuterium Oxide (D2O) Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
this study will employ different D2O doses to assess basal and exercise plus protein feeding-induced rates of acute and integrated MPS in healthy young men and women.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 May 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Why it stopped: COVID and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertrophyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a double blind, randomized, parallel control trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 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 M Phillips, Ph.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256343
- Sponsor's protocol ID
- 8300
- Acronym
- D2O-MPS
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sensitivity of Differing D2O Dosing Strategies and Mass Spectrometry-based Analytical Techniques to Determine Rates of Muscle Protein Synthesis in Young Men and Women
- ClinicalTrials.gov ID
- NCT04256343
- Acronym / sponsor ID
- D2O-MPS / 8300
- Conditions
- Hypertrophy
- Keywords
- Muscle, Muscle protein synthesis, Deuterium
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID and lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 5 Feb 2020 (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.
Skeletal muscle mass is regulated by the balance of muscle protein synthesis (MPS) and muscle protein breakdown (MPB). MPS is sensitive to exogenous stimuli, particularly exercise and protein ingestion. Much of what the investigators currently know about the impact of exercise and protein feeding on MPS has been derived from acute stable isotopic tracers in a controlled laboratory setting. However, recently, the field of skeletal muscle protein metabolism has moved towards the use of deuterium oxide (deuterated water (D2O)) to measure MPS. The ease of administration and the scope to measure turnover in a range of substrates whilst negating the need for strictly controlled laboratory settings makes D2O the ideal candidate to provide a more holistic view of in vivo skeletal muscle metabolism.
Detailed description
Currently, there is a lack of consensus amongst researchers regarding the dosing strategies of D2O provision for measuring fraction-specific (myofibrillar, mitochondrial and sarcoplasmic) protein synthetic rates. In addition, the analytical equipment (i.e., mass spectrometers) required to carry out the analysis of skeletal muscle-bound alanine are technically challenging, offer varying degrees of sensitivity that may drastically influence outcome measures and the expense of analysis differs greatly between the type of mass spectrometer required.Thus, this study will employ different D2O doses to assess basal and exercise plus protein feeding-induced rates of acute and integrated MPS in healthy young men and women. This will provide researchers with insight into the amount of D2O required to accurately assess MPS and the sensitivity of the analytical machine employed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This study will be a double blind, randomized, parallel control trial.
| Arm | Type | Receives |
|---|---|---|
| D2O Dose 1 | Experimental | Other: Deuterium Oxide (D2O) DoseLower dose of D2O for MPS |
| D2O Dose 2 | Experimental | Other: Deuterium Oxide (D2O) DoseModerate dose of D2O MPS |
| D2O Dose 3 | Experimental | Other: Deuterium Oxide (D2O) DoseHigher dose of D2O for MPS |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women, between the ages of 18 - 35 years (inclusive)
- Have a body mass index (BMI) between 18-30 kg·m2 (inclusive)
- Be in general good health as assessed by a general health questionnaire
- Non-smoking
- Willing and able to provide informed consent
Key exclusion criteria (15 listed)
- Ingestion of deuterated water (D2O) in the previous ~6 months.
- Routine/daily usage of non-steroidal anti-inflammatory drugs (NSAIDS, prescription use or daily use of over the counter medication), use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs) within 45 days prior to screening.
- Use of tobacco or related products.
- Veganism or vegetarianism
- Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements.
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 |
|---|---|---|
| Deuterium Oxide (D2O) Dose1 of 3 differing deuterium oxide (D2O) doses will provided to each of the participants to be consumed daily to assess muscle protein synthesis. | Other | D2O Dose 1, D2O Dose 2, D2O Dose 3 |
Primary outcome
Muscle protein synthesis
Time frame: 7 days
this study will employ different D2O doses to assess basal and exercise plus protein feeding-induced rates of acute and integrated MPS in healthy young men and women.
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 15 Mar 2023.
- 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.
Stuart M Phillips, Ph.D. principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Deuterium Oxide (D2O) Dose in people with Hypertrophy, run by McMaster University.
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 15 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Muscle protein synthesis (time frame: 7 days). 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 15 Mar 2023.