Back to resultsD2O Dosing Strategies to Assess Muscle Protein Synthesis (D2O-MPS)
Primary Purpose
Hypertrophy
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deuterium Oxide (D2O) Dose
Sponsored by
About this trial
This is an interventional other trial for Hypertrophy focused on measuring Muscle, Muscle protein synthesis, Deuterium
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
D2O Dose 1
D2O Dose 2
D2O Dose 3
Arm Description
Lower dose of D2O for MPS
Moderate dose of D2O MPS
Higher dose of D2O for MPS
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04256343
Brief Title
D2O Dosing Strategies to Assess Muscle Protein Synthesis
Acronym
D2O-MPS
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID and lack of funding
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy
Keywords
Muscle, Muscle protein synthesis, Deuterium
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a double blind, randomized, parallel control trial.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and the outcomes assessors will be blinded to which dose of D2O the participant received, only the lead principal investigator and the investigators will know which condition each participant has been assigned to. The protein synthesis analysis will be carried out in a blinded fashion such that the individuals utilizing the analytical machines/interpreting the data will be unaware of who was assigned to which condition.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D2O Dose 1
Arm Type
Experimental
Arm Description
Lower dose of D2O for MPS
Arm Title
D2O Dose 2
Arm Type
Experimental
Arm Description
Moderate dose of D2O MPS
Arm Title
D2O Dose 3
Arm Type
Experimental
Arm Description
Higher dose of D2O for MPS
Intervention Type
Other
Intervention Name(s)
Deuterium Oxide (D2O) Dose
Intervention Description
1 of 3 differing deuterium oxide (D2O) doses will provided to each of the participants to be consumed daily to assess muscle protein synthesis.
Primary Outcome Measure Information:
Title
Muscle protein synthesis
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart M Phillips, Ph.D.
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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D2O Dosing Strategies to Assess Muscle Protein Synthesis
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