Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis
ARLA-WHEY
1 other identifier
interventional
20
1 country
1
Brief Summary
Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. Undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many diseases and scenarios including ageing, bed rest/immobilisation, cancer and physical inactivity. Despite the exact mechanisms causing muscle atrophy being not yet fully understood, "anabolic resistance" (reduced muscle building in response to protein feeding and exercise) is thought to be key, especially for age-related skeletal muscle losses (known as sarcopenia). As such, the search for optimal strategies (e.g., exercise and/ or nutritional interventions) to combat this anabolic blunting remains a hot-topic in scientific research. Leucine, an essential and branched chain amino acid (EAA/BCAA), is thought to be the most potent AA for stimulating muscle protein synthesis (MPS; the muscle building process). Although, as a stand-alone supplement, leucine is unlikely to provoke a robust and prolonged state of MPS, low doses of leucine-enriched mixed-EAAs can elicit similar increases in MPS as compared to a large dose of whey protein. As reduced appetite and increased satiety (feeling fuller) are common with advancing age, supplementation of a low-dose protein (i.e., leucine-enriched) that can adequately stimulate MPS may contribute to muscle health maintenance in older adults and reduce satiation following a meal. This study aims to examine whether a novel whey protein with greater leucine content ("super-whey") has superior muscle building properties compared to a regular whey protein, at rest and after a single bout of exercise, in both young and older adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2021
CompletedFirst Submitted
Initial submission to the registry
August 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2023
CompletedJanuary 27, 2023
January 1, 2023
1.4 years
August 4, 2021
January 17, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Muscle protein fractional synthetic rate (postabsorptive)
Postabsorptive measures of muscle protein synthesis assessed in muscle tissue (collected by muscle biopsy). This outcome will be assessed prior to administering a protein drink to obtain muscle protein fractional synthetic rate in the fasted state.
Assessed at 3 hour mark
Muscle protein fractional synthetic rate (postprandial)
Postprandial measures of muscle protein synthesis assessed in muscle tissue (collected by muscle biopsy). This outcome will be assessed following administering a protein drink to obtain muscle protein fractional synthetic rate in the fed state.
Assessed at 6 hour mark
Secondary Outcomes (1)
Plasma amino acid concentrations
Assessed over 7.5 hours
Study Arms (2)
Super-Whey protein
EXPERIMENTALBoth protein sources will be given in doses that are considered low/normal, both in relation to recommended dietary advice and commercially available supplements. As such, no adverse reactions or side effects are expected through consumption of these supplementations
Isonitrogenous whey protein
ACTIVE COMPARATORBoth protein sources will be given in doses that are considered low/normal, both in relation to recommended dietary advice and commercially available supplements. As such, no adverse reactions or side effects are expected through consumption of these supplementations
Interventions
2 different protein supplements (as above) will be given in a randomised crossover fashion to participants
2 different protein supplements (as above) will be given in a randomised crossover fashion to participants
Eligibility Criteria
You may qualify if:
- Participant is in the desired age-ranges (young adults: 18-35 years; older adults: 65+ years).
- Participant is willing and able to give informed consent for participation in the study.
- Participant is physically able to perform resistance exercise
You may not qualify if:
- A BMI \<18 or \>35 kg/m2
- Active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (BP \> 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event, COPD, pulmonary hypertension or recent (6 mo) stroke
- Any metabolic disease
- Clotting dysfunction
- A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy)
- Lactose intolerance
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre of Ageing, Metabolism and Physiology
Derby, DE22 3DT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Atherton, Prof
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 4, 2021
First Posted
January 27, 2023
Study Start
June 15, 2021
Primary Completion
November 22, 2022
Study Completion
November 22, 2022
Last Updated
January 27, 2023
Record last verified: 2023-01