D2O Dosing Strategies to Assess Muscle Protein Synthesis

NCT04256343 | Withdrawn

• 1 other identifier: 8300
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertrophy

Keywords

Muscle; Muscle protein synthesis; Deuterium

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Study Arms (3)

D2O Dose 1

EXPERIMENTAL

Lower dose of D2O for MPS

Other: Deuterium Oxide (D2O) Dose

D2O Dose 2

EXPERIMENTAL

Moderate dose of D2O MPS

Other: Deuterium Oxide (D2O) Dose

D2O Dose 3

EXPERIMENTAL

Higher dose of D2O for MPS

Other: Deuterium Oxide (D2O) Dose

Interventions

Deuterium Oxide (D2O) Dose OTHER

1 of 3 differing deuterium oxide (D2O) doses will provided to each of the participants to be consumed daily to assess muscle protein synthesis.

D2O Dose 1; D2O Dose 2; D2O Dose 3

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Hypertrophy

Interventions

Deuterium Oxide

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Deuterium; Hydrogen; Elements; Gases

Study Officials

• Stuart M Phillips, Ph.D.

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study will be a double blind, randomized, parallel control trial.

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: May 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: June 1, 2021
• Last Updated: March 15, 2023

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share