4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Protein Quality to Support Increased Muscle Protein Synthesis

Protein Quality to Support Increased Muscle Protein Synthesis

Study Description
Brief Summary:
The age-related decline in muscle mass and strength is collectively referred to as sarcopenia. Canadian recommended daily allowance (RDA) for protein intake (0.8 g/kg/d), however, many expert groups have advocated that older persons should increase their daily intake to ~1.2 g/kg/d to support the preservation of muscle mass. The use of plant-based proteins in food formulation has recently become of interest. This study will examine the impact of consuming higher- versus lower-quality protein supplements on muscle protein synthesis in healthy older men.

Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: Protein Supplementation Not Applicable

Detailed Description:
This study will examine the impact of consuming higher- versus lower-quality protein supplements on the integrated rates of muscle protein synthesis in healthy older men. Briefly, participants will consume dietary protein at the RDA for the entire duration of the protocol (2 weeks). Participants will be randomized to consuming collagen (control - CON), whey (WHEY), or pea (PEA) protein supplements twice daily for one week. We will examine the ability of different qualities of protein supplements to stimulate integrated rates of muscle protein synthesis.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be a double blind, randomized parallel group controlled trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants and the investigators will be blinded to the supplement type, only the Lead Principal Investigator will have the codes to decipher the supplement type. Supplements are referred to as A, B and C.
Primary Purpose: Prevention
Official Title: Efficacy of Higher Versus Lower Quality Protein Supplementation to Support Increased Muscle Protein Synthesis in Older Men
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Whey Protein Supplement
Supplements will be consumed twice daily (25g per serving x 2 servings/day)
 Dietary Supplement: Protein Supplementation
Participants will continue to ingest the standardized diet; however, supplements will be consumed twice daily (25g per serving x 2 servings/day or 50g supplemental protein/day)
Experimental: Pea Protein Supplement
Supplements will be consumed twice daily (25g per serving x 2 servings/day)
 Dietary Supplement: Protein Supplementation
Participants will continue to ingest the standardized diet; however, supplements will be consumed twice daily (25g per serving x 2 servings/day or 50g supplemental protein/day)
Experimental: Collagen Protein Supplement
Supplements will be consumed twice daily (25g per serving x 2 servings/day)
 Dietary Supplement: Protein Supplementation
Participants will continue to ingest the standardized diet; however, supplements will be consumed twice daily (25g per serving x 2 servings/day or 50g supplemental protein/day)
Outcome Measures
Primary Outcome Measures :
  1. Integrated Muscle Protein Synthesis [ Time Frame: 7 days x 2 ]

    Integrated protein synthesis will be determined during 7 days of consuming the RDA of protein (control phase), and during 7 days of supplementation with a randomised protein supplement (Supplement phase).

    Integrated rates of muscle protein synthesis (MPS) will be determined using the D2O method. Briefly, 2H enrichment of saliva (precursor) and muscle (product) pools (relative to 1H) will be determined using isotope ratio mass spectrometry and 'myofibrillar fractional synthetic rate' (%/day) determined.



Secondary Outcome Measures :
  1. Anabolic Signalling Proteins [ Time Frame: 1 hour ]

    The effect of each protein supplement on anabolic signalling proteins 1h post-ingestion.

    Briefly, the phosphorylation status (activation) of anabolic signalling proteins will be determined by western blot analysis, and the fold change from that basal state will be presented.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men, between the ages of 65 - 80 years (inclusive)
  2. Willing and able to provide informed consent
  3. Be in general good health, non-smoking
  4. Have a body mass index (BMI) between 20-38 kg/m2 (inclusive)

Exclusion Criteria:

  1. Use of tobacco or related products.
  2. Veganism or vegetarianism
  3. 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.
  4. Use assistive walking devices (e.g., cane or walker)
  5. 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.
  6. 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.
  7. 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
  8. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
  9. Hypersensitivity or known allergy to any of the components in the test formulations.
  10. Excessive alcohol consumption (>21 units/week)
  11. 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).
  12. History of statin myalgia.
  13. Personal or family history of clotting disorder or deep vein thrombosis;
  14. 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: James McKendry, Ph.D. 365 888-2291 mckendrj@mcmaster.ca
Contact: Jonathan McLeod, M.Sc. mcleoj2@mcmaster.ca

Locations
Layout table for location information
Canada, Ontario
Ivor Wynne Centre Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Todd Prior, M.Sc.    905 525 9140 ext 23596    priort@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Investigators
Layout table for investigator information
Principal Investigator: Stuart Phillips, Ph.D. McMaster University
Tracking Information
First Submitted Date  ICMJE July 15, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019) 		Integrated Muscle Protein Synthesis [ Time Frame: 7 days x 2 ]
Integrated protein synthesis will be determined during 7 days of consuming the RDA of protein (control phase), and during 7 days of supplementation with a randomised protein supplement (Supplement phase). Integrated rates of muscle protein synthesis (MPS) will be determined using the D2O method. Briefly, 2H enrichment of saliva (precursor) and muscle (product) pools (relative to 1H) will be determined using isotope ratio mass spectrometry and 'myofibrillar fractional synthetic rate' (%/day) determined.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019) 		Anabolic Signalling Proteins [ Time Frame: 1 hour ]
The effect of each protein supplement on anabolic signalling proteins 1h post-ingestion. Briefly, the phosphorylation status (activation) of anabolic signalling proteins will be determined by western blot analysis, and the fold change from that basal state will be presented.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protein Quality to Support Increased Muscle Protein Synthesis
Official Title  ICMJE Efficacy of Higher Versus Lower Quality Protein Supplementation to Support Increased Muscle Protein Synthesis in Older Men
Brief Summary The age-related decline in muscle mass and strength is collectively referred to as sarcopenia. Canadian recommended daily allowance (RDA) for protein intake (0.8 g/kg/d), however, many expert groups have advocated that older persons should increase their daily intake to ~1.2 g/kg/d to support the preservation of muscle mass. The use of plant-based proteins in food formulation has recently become of interest. This study will examine the impact of consuming higher- versus lower-quality protein supplements on muscle protein synthesis in healthy older men.
Detailed Description This study will examine the impact of consuming higher- versus lower-quality protein supplements on the integrated rates of muscle protein synthesis in healthy older men. Briefly, participants will consume dietary protein at the RDA for the entire duration of the protocol (2 weeks). Participants will be randomized to consuming collagen (control - CON), whey (WHEY), or pea (PEA) protein supplements twice daily for one week. We will examine the ability of different qualities of protein supplements to stimulate integrated rates of muscle protein synthesis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The study will be a double blind, randomized parallel group controlled trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participants and the investigators will be blinded to the supplement type, only the Lead Principal Investigator will have the codes to decipher the supplement type. Supplements are referred to as A, B and C.
Primary Purpose: Prevention
Condition  ICMJE Sarcopenia
Intervention  ICMJE Dietary Supplement: Protein Supplementation
Participants will continue to ingest the standardized diet; however, supplements will be consumed twice daily (25g per serving x 2 servings/day or 50g supplemental protein/day)
Study Arms  ICMJE
  • Experimental: Whey Protein Supplement
    Supplements will be consumed twice daily (25g per serving x 2 servings/day)
    Intervention: Dietary Supplement: Protein Supplementation
  • Experimental: Pea Protein Supplement
    Supplements will be consumed twice daily (25g per serving x 2 servings/day)
    Intervention: Dietary Supplement: Protein Supplementation
  • Experimental: Collagen Protein Supplement
    Supplements will be consumed twice daily (25g per serving x 2 servings/day)
    Intervention: Dietary Supplement: Protein Supplementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019) 		45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men, between the ages of 65 - 80 years (inclusive)
  2. Willing and able to provide informed consent
  3. Be in general good health, non-smoking
  4. Have a body mass index (BMI) between 20-38 kg/m2 (inclusive)

Exclusion Criteria:

  1. Use of tobacco or related products.
  2. Veganism or vegetarianism
  3. 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.
  4. Use assistive walking devices (e.g., cane or walker)
  5. 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.
  6. 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.
  7. 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
  8. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
  9. Hypersensitivity or known allergy to any of the components in the test formulations.
  10. Excessive alcohol consumption (>21 units/week)
  11. 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).
  12. History of statin myalgia.
  13. Personal or family history of clotting disorder or deep vein thrombosis;
  14. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: James McKendry, Ph.D. 365 888-2291 mckendrj@mcmaster.ca
Contact: Jonathan McLeod, M.Sc. mcleoj2@mcmaster.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026607
Other Study ID Numbers  ICMJE 7360
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stuart Phillips, McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stuart Phillips, Ph.D. McMaster University
PRS Account McMaster University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯