SarcopeniaARLA-WHEYNCT05701202
Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis
A study testing Super-Whey protein and Isonitrogenous whey protein in people with Sarcopenia, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Super-Whey protein and Isonitrogenous whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2021to 22 Nov 2022
- 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 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre of Ageing, Metabolism and Physiology
Derby, DE22 3DT
About this study
Official title: Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis at Rest and in Response to Acute Resistance Exercise Across the Lifespan
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
- Conditions
- Sarcopenia
- Being tested
- Super-Whey protein, Isonitrogenous whey protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super-Whey proteinDietary supplement
2 different protein supplements (as above) will be given in a randomised crossover fashion to participants
Isonitrogenous whey proteinDietary supplement
2 different protein supplements (as above) will be given in a randomised crossover fashion to participants
| Study group | Role | What they receive |
|---|---|---|
| Super-Whey protein | Experimental | Both 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 Receives: Dietary Supplement: Super-Whey protein |
| Isonitrogenous whey protein | Active comparator | Both 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 Receives: Dietary Supplement: Isonitrogenous whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed at 6 hour mark
Secondary outcomes (1)
Plasma amino acid concentrations
During the fasted and fed states of the study, blood samples are collected every 20 minutes to capture the plasma amino acid concentrations in the blood at that time-point (24 timepoints assessed). Future analysis using mass-spectroscopy will allow determination of the different amino acid concentrations in the blood plasma collected.
Measured: Assessed over 7.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start15 Jun 2021
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Atherton, University of Nottingham
- Investigators
- Philip Atherton, Prof, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701202
- Sponsor's protocol ID
- ARLA-WHEY_PtA_CMMP
- Acronym
- ARLA-WHEY
- Status last verified
- Jan 2023
- First submitted
- 4 Aug 2021
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis at Rest and in Response to Acute Resistance Exercise Across the Lifespan
- ClinicalTrials.gov ID
- NCT05701202
- Acronym / sponsor ID
- ARLA-WHEY / ARLA-WHEY_PtA_CMMP
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 27 Jan 2023 (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 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super-Whey protein | Experimental | Dietary Supplement: Super-Whey proteinBoth 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 comparator | Dietary Supplement: Isonitrogenous whey proteinBoth 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| Super-Whey protein2 different protein supplements (as above) will be given in a randomised crossover fashion to participants | Dietary supplement | Super-Whey protein |
| Isonitrogenous whey protein2 different protein supplements (as above) will be given in a randomised crossover fashion to participants | Dietary supplement | Isonitrogenous whey protein |
Primary outcome
Muscle protein fractional synthetic rate (postabsorptive)
Time frame: Assessed at 3 hour mark
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.
Muscle protein fractional synthetic rate (postprandial)
Time frame: Assessed at 6 hour mark
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.
1 secondary outcome
Plasma amino acid concentrations
Time frame: Assessed over 7.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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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.
Philip Atherton, Prof principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super-Whey protein and Isonitrogenous whey protein in people with Sarcopenia, run by University of Nottingham at 1 site in United Kingdom.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 fractional synthetic rate (postabsorptive) (time frame: Assessed at 3 hour mark). The study lists 2 primary outcomes in all. 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 27 Jan 2023.