SarcopeniaNCT05574205
Dietary Protein Quality for Skeletal Muscle Anabolism in Older Adults
A study testing Resistance Exercise and Protein supplementation in people with Sarcopenia and Dietary Protein, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
Dietary proteins potently augment muscle protein synthesis. Because of poorer anabolic sensitivity with ageing, studies and guidelines recommend higher dietary protein intake for older adults. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Dietary Protein, Resistance Exercise
- What is being tested?
- Resistance Exercise and Protein supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 1 Jan 2024
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Females aged between 50-70 years
- Accustomed to normal physical activity levels (averaging at least 7000 steps a day)
- Healthy body mass (i.e., BMI 18-25 kg/m2)
- General good health indicated by health questionnaire
- Free from COVID-19 (SARS-CoV-2) symptoms.
Who cannot join
- Habitually high consumers of protein (>1.6g/kg/day) assessed by habitual diet diary
- Food allergies
- Lidocaine allergy
- Smoker
- Bleeding Disorders
- Chronic/systemic illnesses (i.e., renal failure, rheumatoid arthritis, diabetes, poor lung function, heart disease, cancer, uncontrolled hypertension)
- Regular consumption of any analgesic or anti-inflammatory drugs. Taking medications mknown to affect muscle metabolis (e.g. beta-blockers, corticosteroids).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences
Edgbaston, West Midlands, B15 2TT
About this study
Official title: The Importance of Dietary Protein Quality for Skeletal Muscle Anabolism in Older Adults
Dietary proteins potently augment muscle protein synthesis. Because of poorer anabolic sensitivity with ageing, studies and guidelines recommend higher dietary protein intake for older adults. Although higher doses would benefit skeletal muscle remodelling, large protein consumption is not feasible for many older adults. To circumvent, high-protein quality which possesses a high amino acid profile and digestibility appears to have an emergent role for supporting anabolism. Since currently the best line of defence against age related muscle loss is resistance exercise training and regular protein consumption, emphasising high-quality protein ingestion, such as whey protein, within meals may be feasible and efficacious in supporting musculoskeletal remodelling in older adults, without requirement for large protein doses.
The investigators propose that at low doses, high quality protein will have additive benefit to muscle protein synthesis compared to low-quality protein. Further, combining high-quality protein diets with resistance exercise training will have more profound benefits for muscle protein synthesis and muscle remodelling more so than low-quality protein diets.
Read the detailed description
Participants will be randomly assigned to a 10-day dietary intervention consuming primarily animal proteins (high-quality condition) or primarily plant proteins (low-quality condition). In both conditions, participants will undertake supervised single-leg resistance exercise training every other day, amassing five days resistance exercise sessions during the study. The groups will aim to be matched and counterbalanced for gender. Equally for unilateral exercise randomisation for leg dominance will aim to be counterbalanced within both groups.
Preliminary assessments:
5 days preceding the start of the dietary intervention, participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science for the following:
- Health questionnaire
- Written informed consent
- Anthropometrics (Height and Weight)
- Body fat (bioelectrical impedance)
- Start measuring habitual activity (provided with an activity monitor and pedometer)
- Start measuring habitual diet (provided with diet diary)
2 days preceding the start of the dietary intervention, participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science for the following:
- Saliva sample (participant gives own saliva sample in a tube)
- 10ml of blood taken for baseline measures (venepuncture by trained phlebotomist)
- Loading dose of D2O (stable isotope of water ingested in 8 small 50ml doses taken 1 hour apart throughout the day)
- Find 1 repetition maximum (1RM) during unilateral knee extension.
Dietary intervention each day throughout 10-day intervention participants will provide a saliva sample and then consume a top up dose of D2O, continue wearing an activity tracker and keep a diet diary to record eating times of provided meals.
Meals will be individualised to body weight for each individual to achieve a moderate protein intake of which will then consist of primarily higher quality or lower quality proteins.
Day 0 (first day of diet), participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science at 0800h after fasting >10 hours the night prior for the following:
- Resting metabolic rate (Laying down for 30 minutes to assess gaseous exchange while wearing a mask)
- Muscle architecture (using non-invasive ultrasonography)
- Whole-body composition assessment (DXA scan)
- Bilateral muscle biopsies (small amount of muscle will be taken from the muscle in the thigh (vastus lateralis) by a trained person from the left and right leg, under local anaesthetic)
- Maximal muscle strength (isometric dynamometry) and neural activation (interpolated twitch) during maximal muscle contraction on both legs in series.
- Serial blood samples will be taken with a single cannulisation and 8 10ml blood draws taken throughout the visit (before and after consuming a breakfast which is either higher or lower in protein quality, according to the randomised condition).
- Perceived appetite will be assessed during the visit, before and after breakfast, using visual analogue scales
- Urine collection tub will be provided to collect urine over the next 24-hours.
After consuming specified breakfast on this visit, participants will continue to eat meals given to them according to their random allocation of either higher or lower quality protein diets.
Day 1, 3, 5, 7, 9
Participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science to undergo single-leg resistance exercise on a knee extension machine. Eight sets will be completed on the machine at each visit at 75% of 1RM (determined during preliminary visits and will be supervised).
On day 9, the participant will be given a urine collection tub to collect urine over the next 24-hours.
Day 10 (Diet finishing during this visit), participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science at 0800h after fasting >10 hours the night prior for the following assessments:
- Resting metabolic rate (Laying down for 30 minutes to assess gaseous exchange while wearing a mask)
- Whole-body composition assessment (DXA scan)
- Muscle Architecture (using non-invasive ultrasonography)
- Maximal muscle strength (Isometric Dynamometry) and neural activation during maximal muscle contraction (Interpolated twitch)
- Bilateral muscle biopsies (small amount of muscle will be taken from the muscle in the thigh (vastus lateralis) from the left and right leg under local anaesthetic
- Serial blood samples will be taken with a single cannulisation and 8 10ml blood draws taken throughout the visit (before and after consuming the final meal of the diet which is the breakfast which is either higher or lower in protein quality, according to the randomised condition)
- Perceived appetite will be assessed during the visit, before and after breakfast, using visual analogue scales.
- Conditions
- Sarcopenia, Dietary Protein, Resistance Exercise
- Being tested
- Resistance Exercise, Protein supplementation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseOther
Also called Single-leg resistance exercise
Supervised single-leg (unilateral) exercise will be undertaken every other day throughout the dietary intervention
Protein supplementationDietary supplement
Participants will consume a protein supplement alongside a provided diet to control protein amount and quality.
| Study group | Role | What they receive |
|---|---|---|
| High Quality Protein | Experimental | Participants will consume four high-quality protein containing meals per day (amounting to 1g/kg/day of protein) over a 10-day period. Each meal will contain 75:25 animal:plant protein with most of the animal protein from supplemental high-quality protein powder. Receives: Other: Resistance Exercise; Dietary Supplement: Protein supplementation |
| Low Quality Protein | Experimental | Participants will consume four low-quality protein containing meals per day (amounting to 1g/kg/day of protein) over a 10-day period. Each meal will contain 25:75 animal:plant protein with most of the plant protein from supplemental low-quality protein powder. Receives: Other: Resistance Exercise; Dietary Supplement: Protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis using muscle biopsies and deuterated water enrichment.
Muscle protein synthesis will be assessed during the high-quality and low-quality intervention and compared between exercised and controlled leg.
Measured: 0-10 days
Leg Strength using dynamometry
Evaluating change in leg strength, of trained leg, pre- and post-intervention with high-quality and low-quality protein condition
Measured: 0-10 days
Neural activation using interpolated twitch
Assessing change in neural activation via non-invasive interpolated twitch technique of between exercised legs pre-and post intervention in both protein quality conditions
Measured: 0-10 days
Muscle architecture using ultrasound
Using non-invasive ultrasound to determine change of muscle structure with training between protein quality conditions.
Measured: 0-10 days
Secondary outcomes (8)
Appetite regulation using questionnaires
Assessing perceived hunger using a validated, 8 question, 100mm visual analogue scales.
Measured: 0-10 days (3 hours postprandial)
Appetite regulation, blood
Assessing the secretion of hunger and appetite hormones within the blood after meals which contain high-quality versus low-quality protein.
Measured: 0-10 days (3 hours postprandial)
Metabolic rate, metabolic cart
Evaluating alterations in energy expenditure before and after high-quality or low-quality protein containing meal using a metabolic cart.
Measured: 0-10 days
Nitrogen balance from urine and dietary protein intake
Evaluating change in nitrogen balance between adhering to high-quality or low-quality protein diets over a 10-day period
Measured: 0-10 days (24-hour urine collection)
Body composition using Duel- energy x-ray absorptiometry (DXA) scan.
Change in body composition (muscle mass, fat mass, bone mineral density) will be evaluated using a DXA scanner before and after adhering to single leg resistance exercise paired with either high-quality or low-quality protein diet.
Measured: 0-10 days
Muscle fibre specific analysis using immunofluorescence microscopy.
Evaluate changes in fibre specific differences in the distribution and localisation of key anabolic markers between trained and untrained legs for both protein quality conditions.
Measured: 0-10 days
Intramuscular signalling using western blotting
Evaluate changes in protein content and phosphorylation from the start to the end of the intervention.
Measured: 0-10 days
Physical activity levels using accelerometery and pedometer
Monitoring of habitual and habitual physical activity to evaluate if intensity and duration of activity is similar between habitual and intervention.
Measured: -5-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Nov 2021
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the high-quality or low-quality condition. Within both conditions single-leg resistance exercise will be undertaken meaning the other non-exercise leg for each participant will act as their own internal control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574205
- Sponsor's protocol ID
- RG_20-157
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2022
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Korzepa M, Quinlan JI, Marshall RN, Rogers LM, Belfield AE, Elhassan YS, Lawson A, Ayre C, Senden JM, Goessens JP, Glover EI, Wallis GA, van Loon LJ, Breen L. Resistance training increases myofibrillar protein synthesis in middle-to-older aged adults consuming a typical diet with no influence of protein source: a randomized controlled trial. Am J Clin Nutr. 2025 Jul;122(1):122-136. doi: 10.1016/j.ajcnut.2025.04.019. Epub 2025 Apr 25.
PubMed 40288581
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Dietary Protein Quality for Skeletal Muscle Anabolism in Older Adults
- ClinicalTrials.gov ID
- NCT05574205
- Acronym / sponsor ID
- RG_20-157
- Conditions
- Sarcopenia, Dietary Protein, Resistance Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 10 Oct 2022 (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.
Dietary proteins potently augment muscle protein synthesis. Because of poorer anabolic sensitivity with ageing, studies and guidelines recommend higher dietary protein intake for older adults. Although higher doses would benefit skeletal muscle remodelling, large protein consumption is not feasible for many older adults. To circumvent, high-protein quality which possesses a high amino acid profile and digestibility appears to have an emergent role for supporting anabolism. Since currently the best line of defence against age related muscle loss is resistance exercise training and regular protein consumption, emphasising high-quality protein ingestion, such as whey protein, within meals may be feasible and efficacious in supporting musculoskeletal remodelling in older adults, without requirement for large protein doses.
The investigators propose that at low doses, high quality protein will have additive benefit to muscle protein synthesis compared to low-quality protein. Further, combining high-quality protein diets with resistance exercise training will have more profound benefits for muscle protein synthesis and muscle remodelling more so than low-quality protein diets.
Detailed description
Participants will be randomly assigned to a 10-day dietary intervention consuming primarily animal proteins (high-quality condition) or primarily plant proteins (low-quality condition). In both conditions, participants will undertake supervised single-leg resistance exercise training every other day, amassing five days resistance exercise sessions during the study. The groups will aim to be matched and counterbalanced for gender. Equally for unilateral exercise randomisation for leg dominance will aim to be counterbalanced within both groups.
Preliminary assessments:
5 days preceding the start of the dietary intervention, participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science for the following:
- Health questionnaire
- Written informed consent
- Anthropometrics (Height and Weight)
- Body fat (bioelectrical impedance)
- Start measuring habitual activity (provided with an activity monitor and pedometer)
- Start measuring habitual diet (provided with diet diary)
2 days preceding the start of the dietary intervention, participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science for the following:
- Saliva sample (participant gives own saliva sample in a tube)
- 10ml of blood taken for baseline measures (venepuncture by trained phlebotomist)
- Loading dose of D2O (stable isotope of water ingested in 8 small 50ml doses taken 1 hour apart throughout the day)
- Find 1 repetition maximum (1RM) during unilateral knee extension.
Dietary intervention each day throughout 10-day intervention participants will provide a saliva sample and then consume a top up dose of D2O, continue wearing an activity tracker and keep a diet diary to record eating times of provided meals.
Meals will be individualised to body weight for each individual to achieve a moderate protein intake of which will then consist of primarily higher quality or lower quality proteins.
Day 0 (first day of diet), participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science at 0800h after fasting >10 hours the night prior for the following:
- Resting metabolic rate (Laying down for 30 minutes to assess gaseous exchange while wearing a mask)
- Muscle architecture (using non-invasive ultrasonography)
- Whole-body composition assessment (DXA scan)
- Bilateral muscle biopsies (small amount of muscle will be taken from the muscle in the thigh (vastus lateralis) by a trained person from the left and right leg, under local anaesthetic)
- Maximal muscle strength (isometric dynamometry) and neural activation (interpolated twitch) during maximal muscle contraction on both legs in series.
- Serial blood samples will be taken with a single cannulisation and 8 10ml blood draws taken throughout the visit (before and after consuming a breakfast which is either higher or lower in protein quality, according to the randomised condition).
- Perceived appetite will be assessed during the visit, before and after breakfast, using visual analogue scales
- Urine collection tub will be provided to collect urine over the next 24-hours.
After consuming specified breakfast on this visit, participants will continue to eat meals given to them according to their random allocation of either higher or lower quality protein diets.
Day 1, 3, 5, 7, 9
Participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science to undergo single-leg resistance exercise on a knee extension machine. Eight sets will be completed on the machine at each visit at 75% of 1RM (determined during preliminary visits and will be supervised).
On day 9, the participant will be given a urine collection tub to collect urine over the next 24-hours.
Day 10 (Diet finishing during this visit), participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science at 0800h after fasting >10 hours the night prior for the following assessments:
- Resting metabolic rate (Laying down for 30 minutes to assess gaseous exchange while wearing a mask)
- Whole-body composition assessment (DXA scan)
- Muscle Architecture (using non-invasive ultrasonography)
- Maximal muscle strength (Isometric Dynamometry) and neural activation during maximal muscle contraction (Interpolated twitch)
- Bilateral muscle biopsies (small amount of muscle will be taken from the muscle in the thigh (vastus lateralis) from the left and right leg under local anaesthetic
- Serial blood samples will be taken with a single cannulisation and 8 10ml blood draws taken throughout the visit (before and after consuming the final meal of the diet which is the breakfast which is either higher or lower in protein quality, according to the randomised condition)
- Perceived appetite will be assessed during the visit, before and after breakfast, using visual analogue scales.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the high-quality or low-quality condition. Within both conditions single-leg resistance exercise will be undertaken meaning the other non-exercise leg for each participant will act as their own internal control.
| Arm | Type | Receives |
|---|---|---|
| High Quality Protein | Experimental | Other: Resistance Exercise, Dietary Supplement: Protein supplementationParticipants will consume four high-quality protein containing meals per day (amounting to 1g/kg/day of protein) over a 10-day period. Each meal will contain 75:25 animal:plant protein with most of the animal protein from supplemental high-quality protein powder. |
| Low Quality Protein | Experimental | Other: Resistance Exercise, Dietary Supplement: Protein supplementationParticipants will consume four low-quality protein containing meals per day (amounting to 1g/kg/day of protein) over a 10-day period. Each meal will contain 25:75 animal:plant protein with most of the plant protein from supplemental low-quality protein powder. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and Females aged between 50-70 years
- Accustomed to normal physical activity levels (averaging at least 7000 steps a day)
- Healthy body mass (i.e., BMI 18-25 kg/m2)
- General good health indicated by health questionnaire
- Free from COVID-19 (SARS-CoV-2) symptoms.
Key exclusion criteria (7 listed)
- Habitually high consumers of protein (>1.6g/kg/day) assessed by habitual diet diary
- Food allergies
- Lidocaine allergy
- Smoker
- Bleeding Disorders
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 |
|---|---|---|
| Resistance ExerciseAlso: Single-leg resistance exerciseSupervised single-leg (unilateral) exercise will be undertaken every other day throughout the dietary intervention | Other | High Quality Protein, Low Quality Protein |
| Protein supplementationParticipants will consume a protein supplement alongside a provided diet to control protein amount and quality. | Dietary supplement | High Quality Protein, Low Quality Protein |
Primary outcome
Muscle protein synthesis using muscle biopsies and deuterated water enrichment.
Time frame: 0-10 days
Muscle protein synthesis will be assessed during the high-quality and low-quality intervention and compared between exercised and controlled leg.
Leg Strength using dynamometry
Time frame: 0-10 days
Evaluating change in leg strength, of trained leg, pre- and post-intervention with high-quality and low-quality protein condition
Neural activation using interpolated twitch
Time frame: 0-10 days
Assessing change in neural activation via non-invasive interpolated twitch technique of between exercised legs pre-and post intervention in both protein quality conditions
Muscle architecture using ultrasound
Time frame: 0-10 days
Using non-invasive ultrasound to determine change of muscle structure with training between protein quality conditions.
8 secondary outcomes
Appetite regulation using questionnaires
Time frame: 0-10 days (3 hours postprandial)
Appetite regulation, blood
Time frame: 0-10 days (3 hours postprandial)
Metabolic rate, metabolic cart
Time frame: 0-10 days
Nitrogen balance from urine and dietary protein intake
Time frame: 0-10 days (24-hour urine collection)
Body composition using Duel- energy x-ray absorptiometry (DXA) scan.
Time frame: 0-10 days
Muscle fibre specific analysis using immunofluorescence microscopy.
Time frame: 0-10 days
Intramuscular signalling using western blotting
Time frame: 0-10 days
Physical activity levels using accelerometery and pedometer
Time frame: -5-10 days
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 1 Aug 2024.
- Derived from this study: PubMed 40288581Korzepa M, Quinlan JI, Marshall RN, Rogers LM, Belfield AE, Elhassan YS, Lawson A, Ayre C, Senden JM, Goessens JP, Glover EI, Wallis GA, van Loon LJ, Breen L. Resistance training increases myofibrillar protein synthesis in middle-to-older aged adults consuming a typical diet with no influence of protein source: a randomized controlled trial. Am J Clin Nutr. 2025 Jul;122(1):122-136. doi: 10.1016/j.ajcnut.2025.04.019. Epub 2025 Apr 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise and Protein supplementation in people with Sarcopenia and Dietary Protein, run by University of Birmingham 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 5 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 1 Aug 2024. 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 synthesis using muscle biopsies and deuterated water enrichment. (time frame: 0-10 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05574205, which also lists 1 linked publication.
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 1 Aug 2024.