Vitamin D Effects on MPSPhase 2VIPERNCT06746389
Effects of Vitamin D Supplementation on Muscle Protein Synthesis
A Phase 2 study testing 3000 IU per Day Spray in people with Vitamin D Effects on MPS and Placebo Effects on MPS, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Background: Healthy adults maintain muscle tissue by continuously building up and breaking down muscle proteins throughout the day. Studies have shown that vitamin D (VitD) is essential for maintaining muscle mass by activating cellular pathways involved in building muscle via muscle protein synthesis (MPS). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Effects on MPS, Placebo Effects on MPS
- What is being tested?
- 3000 IU per Day Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2020to 23 Oct 2024
- Phase
- Phase 2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 - 45
- Sedentary and moderately active (NDNS)
Who cannot join
- Any diagnosed acute or chronic condition
- Very active (NDNS)
- On medication apart from contraceptive pill
- Not taking vitamin supplementation for 30 days before enrolling
- Not having been exposed to the sun (synthesising months - any country) in the previous 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vitamin D Supplementation on Myofibrillar Protein Synthesis Rates in Rested and Exercised Muscle in Young Adults: a Randomised, Double-blind, Placebo-controlled Trial
Background: Healthy adults maintain muscle tissue by continuously building up and breaking down muscle proteins throughout the day. Studies have shown that vitamin D (VitD) is essential for maintaining muscle mass by activating cellular pathways involved in building muscle via muscle protein synthesis (MPS). Although, various candidate molecules have been identified in animal models, it is not known whether these pathways are activated in humans. Interestingly, animal studies indicate that 20% of VitD is stored in human muscle cells, which may help maintain VitD sufficiency during winter in Northern latitudes when there is not much sunlight Objectives: We will investigate whether VitD supplementation increases the MPS response to feeding and exercise, VitD storage in muscle cells, and cellular pathways that are involved in healthy sedentary or moderately active adults.
Methods: Participants will consume either a placebo (sucrose) or the intervention (vitamin D3, 3000IU/day) for 12 weeks in a double-blinded randomised study. Before and after the intervention participants will have body composition measured. Blood and muscle samples will be taken before and after a bout of exercise and ingestion of 20 g protein in order to measure MPS.
Read the detailed description
Recent in vitro studies have demonstrated an anabolic role of vitamin D directly targeting skeletal muscle via vitamin D receptors (VDR) present in myotubes [1,2,3]. However, this has yet to be translated to in vivo human models.
25-hydroxyvitamin-D (25OHD) is the primary circulating metabolite and reference measurement for vitamin D status. This may then either be converted to 24,25-dihydroxyvitamin D3 (24,25OHD) to prevent intoxication [4] or be activated in the kidneys to 1,25-dihydroxyvitamin D (1,25OHD)[5].
Evidence support a biological role for 1,25OHD in skeletal muscle[1-4,7]. With focus on muscle hypertrophy, a study demonstrated that 25OHD can also be activated to 1,25OHD in myotubes[8] and promote cell proliferation, growth and differentiation of myocytes in in vitro skeletal muscle cells[7,9-13]. The mechanisms proposed include (i) gene expression of endocytic receptors for vitamin D binding protein (VDP) (megalin/cubulin) on the muscle cell surface membrane and (ii) high affinity for VDP to bind to actin inside the muscle cell. Furthermore, epidemiological studies support a positive role for vitamin D in human muscle function[14-21] and mechanistic studies implicate intracellular 25OHD in the regulation of protein metabolism. Cell culture and in vivo animal models demonstrate that 25OHD activates anabolic cell signalling proteins of the mTORC1 pathway in response to anabolic stimuli[21,22], which translates into an increased stimulation of muscle protein synthesis[17]. Despite these exciting results from cell culture and in vivo animal studies, no study has replicated these findings in in vivo human models.
The length of the intervention in studies investigating the effects of vitamin D supplementation on muscle health outcomes and MPS varies between studies; however, evidence supports improvements in fast-twitch muscle fibres in elderly women[18], muscle strength in humans and animals and an increased in MPS in rats and mice following a minimum of 12 weeks intervention [22]. Thus, this study plans to have 12 weeks of intervention to ensure there is sufficient time for a physiologically effect to take place. Seasonal variations in blood 25OHD concentrations have been evaluated in Caucasians residing in Northern Ireland[4]. Thirty-four percent were deficient (<25nmol/L) in winter months[4]; however, despite insufficient sunlight in winter to synthesise vitamin D in skin, a significant proportion of a population resident in the same latitude, in Scotland, maintained blood 25OHD concentrations >50nmol/L[6]. These data and a recent review[8] suggest that humans have evolved a storage mechanism, which allows 25OHD, produced in the summer, to be conserved and used more efficiently in winter.
- Conditions
- Vitamin D Effects on MPS, Placebo Effects on MPS
- Being tested
- 3000 IU per Day Spray
- Keywords
- Muscle Protein Synthesis, Vitamin D, adults, healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3000 IU per Day SprayDietary supplement
Effects of vitamin D supplementation vs placebo on MPS in response to exercise and feeding
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | 3000 IU/Day 12 weeks Receives: Dietary Supplement: 3000 IU per Day Spray |
| Placebo | Placebo comparator | Placebo one/day 12 weeks Receives: Dietary Supplement: 3000 IU per Day Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional synthetic rate of amino acid incorporation into myofibrillar protein
Fractional synthetic rate of amino acid incorporation into myofibrillar protein
Measured: 12 weeks x 4 time points
Secondary outcomes (7)
Phosphorylated mTOR
Phosphorylated mTOR response following 12 weeks intervention vs placebo
Measured: 12 weeks x 4 time points
Total mTOR
Total mTOR following 12 weeks intervention
Measured: 12 weeks x 2 time points
Plasma amino acid kinetics
Plasma amino acid kinetics in response to intervention vs. placebo
Measured: 12 weeks x 16 time points
Glucose
Glucose response to intervention vs. placebo
Measured: 12 weeks x 16 time points
Insulin
Insulin response to intervention vs. placebo
Measured: 12 weeks x 14 time points
Leg press
Leg press - strength
Measured: 12 weeks x 1 x1
Leg extension
Leg extension - Strength
Measured: 12 weeks 1 x 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start8 Oct 2020
- Primary completion23 Jun 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Vitamin D Effects on MPSStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind RCT
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Medical Branch, Galveston, Wageningen University
- Responsible party
- Sponsor
- Investigators
- Raquel Revuelta Iniesta, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746389
- Sponsor's protocol ID
- 201021/B/03
- Acronym
- VIPER
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data protection - participants did not agree to IPD
Publications
Tieland M, Brouwer-Brolsma EM, Nienaber-Rousseau C, van Loon LJ, De Groot LC. Low vitamin D status is associated with reduced muscle mass and impaired physical performance in frail elderly people. Eur J Clin Nutr. 2013 Oct;67(10):1050-5. doi: 10.1038/ejcn.2013.144. Epub 2013 Aug 14.
PubMed 23942175Vignale K, Greene ES, Caldas JV, England JA, Boonsinchai N, Sodsee P, Pollock ED, Dridi S, Coon CN. 25-Hydroxycholecalciferol Enhances Male Broiler Breast Meat Yield through the mTOR Pathway. J Nutr. 2015 May;145(5):855-63. doi: 10.3945/jn.114.207936. Epub 2015 Mar 18.
PubMed 25788584Salles J, Chanet A, Giraudet C, Patrac V, Pierre P, Jourdan M, Luiking YC, Verlaan S, Migne C, Boirie Y, Walrand S. 1,25(OH)2-vitamin D3 enhances the stimulating effect of leucine and insulin on protein synthesis rate through Akt/PKB and mTOR mediated pathways in murine C2C12 skeletal myotubes. Mol Nutr Food Res. 2013 Dec;57(12):2137-46. doi: 10.1002/mnfr.201300074. Epub 2013 Aug 9.
PubMed 23929734Chiang CM, Ismaeel A, Griffis RB, Weems S. Effects of Vitamin D Supplementation on Muscle Strength in Athletes: A Systematic Review. J Strength Cond Res. 2017 Feb;31(2):566-574. doi: 10.1519/JSC.0000000000001518.
PubMed 27379960Beals JW, Sukiennik RA, Nallabelli J, Emmons RS, van Vliet S, Young JR, Ulanov AV, Li Z, Paluska SA, De Lisio M, Burd NA. Anabolic sensitivity of postprandial muscle protein synthesis to the ingestion of a protein-dense food is reduced in overweight and obese young adults. Am J Clin Nutr. 2016 Oct;104(4):1014-1022. doi: 10.3945/ajcn.116.130385. Epub 2016 Sep 7.
PubMed 27604771Montenegro KR, Cruzat V, Carlessi R, Newsholme P. Mechanisms of vitamin D action in skeletal muscle. Nutr Res Rev. 2019 Dec;32(2):192-204. doi: 10.1017/S0954422419000064. Epub 2019 Jun 17.
PubMed 31203824van Vliet S, Fappi A, Reeds DN, Mittendorfer B. No independent or combined effects of vitamin D and conjugated linoleic acids on muscle protein synthesis in older adults: a randomized, double-blind, placebo-controlled clinical trial. Am J Clin Nutr. 2020 Nov 11;112(5):1382-1389. doi: 10.1093/ajcn/nqaa240.
PubMed 32860399Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73. doi: 10.4065/81.3.353.
PubMed 16529140SANC. (2007) Update on Vitamin D: Position Statement by the Scientific Advisory Committee on Nutrition. London: TSO
Mann CJ, Perdiguero E, Kharraz Y, Aguilar S, Pessina P, Serrano AL, Munoz-Canoves P. Aberrant repair and fibrosis development in skeletal muscle. Skelet Muscle. 2011 May 4;1(1):21. doi: 10.1186/2044-5040-1-21.
PubMed 21798099Relaix F, Zammit PS. Satellite cells are essential for skeletal muscle regeneration: the cell on the edge returns centre stage. Development. 2012 Aug;139(16):2845-56. doi: 10.1242/dev.069088.
PubMed 22833472Owens DJ, Sharples AP, Polydorou I, Alwan N, Donovan T, Tang J, Fraser WD, Cooper RG, Morton JP, Stewart C, Close GL. A systems-based investigation into vitamin D and skeletal muscle repair, regeneration, and hypertrophy. Am J Physiol Endocrinol Metab. 2015 Dec 15;309(12):E1019-31. doi: 10.1152/ajpendo.00375.2015. Epub 2015 Oct 27.
PubMed 26506852
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Supplementation on Myofibrillar Protein Synthesis Rates in Rested and Exercised Muscle in Young Adults: a Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06746389
- Acronym / sponsor ID
- VIPER / 201021/B/03
- Conditions
- Vitamin D Effects on MPS, Placebo Effects on MPS
- Keywords
- Muscle Protein Synthesis, Vitamin D, adults, healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- The University of Texas Medical Branch, Galveston, Wageningen University
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 24 Dec 2024 (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.
Background: Healthy adults maintain muscle tissue by continuously building up and breaking down muscle proteins throughout the day. Studies have shown that vitamin D (VitD) is essential for maintaining muscle mass by activating cellular pathways involved in building muscle via muscle protein synthesis (MPS). Although, various candidate molecules have been identified in animal models, it is not known whether these pathways are activated in humans. Interestingly, animal studies indicate that 20% of VitD is stored in human muscle cells, which may help maintain VitD sufficiency during winter in Northern latitudes when there is not much sunlight Objectives: We will investigate whether VitD supplementation increases the MPS response to feeding and exercise, VitD storage in muscle cells, and cellular pathways that are involved in healthy sedentary or moderately active adults.
Methods: Participants will consume either a placebo (sucrose) or the intervention (vitamin D3, 3000IU/day) for 12 weeks in a double-blinded randomised study. Before and after the intervention participants will have body composition measured. Blood and muscle samples will be taken before and after a bout of exercise and ingestion of 20 g protein in order to measure MPS.
Detailed description
Recent in vitro studies have demonstrated an anabolic role of vitamin D directly targeting skeletal muscle via vitamin D receptors (VDR) present in myotubes [1,2,3]. However, this has yet to be translated to in vivo human models.
25-hydroxyvitamin-D (25OHD) is the primary circulating metabolite and reference measurement for vitamin D status. This may then either be converted to 24,25-dihydroxyvitamin D3 (24,25OHD) to prevent intoxication [4] or be activated in the kidneys to 1,25-dihydroxyvitamin D (1,25OHD)[5].
Evidence support a biological role for 1,25OHD in skeletal muscle[1-4,7]. With focus on muscle hypertrophy, a study demonstrated that 25OHD can also be activated to 1,25OHD in myotubes[8] and promote cell proliferation, growth and differentiation of myocytes in in vitro skeletal muscle cells[7,9-13]. The mechanisms proposed include (i) gene expression of endocytic receptors for vitamin D binding protein (VDP) (megalin/cubulin) on the muscle cell surface membrane and (ii) high affinity for VDP to bind to actin inside the muscle cell. Furthermore, epidemiological studies support a positive role for vitamin D in human muscle function[14-21] and mechanistic studies implicate intracellular 25OHD in the regulation of protein metabolism. Cell culture and in vivo animal models demonstrate that 25OHD activates anabolic cell signalling proteins of the mTORC1 pathway in response to anabolic stimuli[21,22], which translates into an increased stimulation of muscle protein synthesis[17]. Despite these exciting results from cell culture and in vivo animal studies, no study has replicated these findings in in vivo human models.
The length of the intervention in studies investigating the effects of vitamin D supplementation on muscle health outcomes and MPS varies between studies; however, evidence supports improvements in fast-twitch muscle fibres in elderly women[18], muscle strength in humans and animals and an increased in MPS in rats and mice following a minimum of 12 weeks intervention [22]. Thus, this study plans to have 12 weeks of intervention to ensure there is sufficient time for a physiologically effect to take place. Seasonal variations in blood 25OHD concentrations have been evaluated in Caucasians residing in Northern Ireland[4]. Thirty-four percent were deficient (<25nmol/L) in winter months[4]; however, despite insufficient sunlight in winter to synthesise vitamin D in skin, a significant proportion of a population resident in the same latitude, in Scotland, maintained blood 25OHD concentrations >50nmol/L[6]. These data and a recent review[8] suggest that humans have evolved a storage mechanism, which allows 25OHD, produced in the summer, to be conserved and used more efficiently in winter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blind RCT
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: 3000 IU per Day Spray3000 IU/Day 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: 3000 IU per Day SprayPlacebo one/day 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults aged 18 - 45
- Sedentary and moderately active (NDNS)
Key exclusion criteria (5 listed)
- Any diagnosed acute or chronic condition
- Very active (NDNS)
- On medication apart from contraceptive pill
- Not taking vitamin supplementation for 30 days before enrolling
- Not having been exposed to the sun (synthesising months - any country) in the previous 30 days
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 |
|---|---|---|
| 3000 IU per Day SprayEffects of vitamin D supplementation vs placebo on MPS in response to exercise and feeding | Dietary supplement | Placebo, Vitamin D |
Primary outcome
Fractional synthetic rate of amino acid incorporation into myofibrillar protein
Time frame: 12 weeks x 4 time points
Fractional synthetic rate of amino acid incorporation into myofibrillar protein
7 secondary outcomes
Phosphorylated mTOR
Time frame: 12 weeks x 4 time points
Total mTOR
Time frame: 12 weeks x 2 time points
Plasma amino acid kinetics
Time frame: 12 weeks x 16 time points
Glucose
Time frame: 12 weeks x 16 time points
Insulin
Time frame: 12 weeks x 14 time points
Leg press
Time frame: 12 weeks x 1 x1
Leg extension
Time frame: 12 weeks 1 x 1
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 24 Dec 2024.
- Background: PubMed 23942175Tieland M, Brouwer-Brolsma EM, Nienaber-Rousseau C, van Loon LJ, De Groot LC. Low vitamin D status is associated with reduced muscle mass and impaired physical performance in frail elderly people. Eur J Clin Nutr. 2013 Oct;67(10):1050-5. doi: 10.1038/ejcn.2013.144. Epub 2013 Aug 14.
- Background: PubMed 25788584Vignale K, Greene ES, Caldas JV, England JA, Boonsinchai N, Sodsee P, Pollock ED, Dridi S, Coon CN. 25-Hydroxycholecalciferol Enhances Male Broiler Breast Meat Yield through the mTOR Pathway. J Nutr. 2015 May;145(5):855-63. doi: 10.3945/jn.114.207936. Epub 2015 Mar 18.
- Background: PubMed 23929734Salles J, Chanet A, Giraudet C, Patrac V, Pierre P, Jourdan M, Luiking YC, Verlaan S, Migne C, Boirie Y, Walrand S. 1,25(OH)2-vitamin D3 enhances the stimulating effect of leucine and insulin on protein synthesis rate through Akt/PKB and mTOR mediated pathways in murine C2C12 skeletal myotubes. Mol Nutr Food Res. 2013 Dec;57(12):2137-46. doi: 10.1002/mnfr.201300074. Epub 2013 Aug 9.
- Background: PubMed 27379960Chiang CM, Ismaeel A, Griffis RB, Weems S. Effects of Vitamin D Supplementation on Muscle Strength in Athletes: A Systematic Review. J Strength Cond Res. 2017 Feb;31(2):566-574. doi: 10.1519/JSC.0000000000001518.
- Background: PubMed 27604771Beals JW, Sukiennik RA, Nallabelli J, Emmons RS, van Vliet S, Young JR, Ulanov AV, Li Z, Paluska SA, De Lisio M, Burd NA. Anabolic sensitivity of postprandial muscle protein synthesis to the ingestion of a protein-dense food is reduced in overweight and obese young adults. Am J Clin Nutr. 2016 Oct;104(4):1014-1022. doi: 10.3945/ajcn.116.130385. Epub 2016 Sep 7.
- Background: PubMed 31203824Montenegro KR, Cruzat V, Carlessi R, Newsholme P. Mechanisms of vitamin D action in skeletal muscle. Nutr Res Rev. 2019 Dec;32(2):192-204. doi: 10.1017/S0954422419000064. Epub 2019 Jun 17.
- Background: PubMed 32860399van Vliet S, Fappi A, Reeds DN, Mittendorfer B. No independent or combined effects of vitamin D and conjugated linoleic acids on muscle protein synthesis in older adults: a randomized, double-blind, placebo-controlled clinical trial. Am J Clin Nutr. 2020 Nov 11;112(5):1382-1389. doi: 10.1093/ajcn/nqaa240.
- Background: PubMed 16529140Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73. doi: 10.4065/81.3.353.
- BackgroundSANC. (2007) Update on Vitamin D: Position Statement by the Scientific Advisory Committee on Nutrition. London: TSO
- Background: PubMed 21798099Mann CJ, Perdiguero E, Kharraz Y, Aguilar S, Pessina P, Serrano AL, Munoz-Canoves P. Aberrant repair and fibrosis development in skeletal muscle. Skelet Muscle. 2011 May 4;1(1):21. doi: 10.1186/2044-5040-1-21.
- Background: PubMed 22833472Relaix F, Zammit PS. Satellite cells are essential for skeletal muscle regeneration: the cell on the edge returns centre stage. Development. 2012 Aug;139(16):2845-56. doi: 10.1242/dev.069088.
- Background: PubMed 26506852Owens DJ, Sharples AP, Polydorou I, Alwan N, Donovan T, Tang J, Fraser WD, Cooper RG, Morton JP, Stewart C, Close GL. A systems-based investigation into vitamin D and skeletal muscle repair, regeneration, and hypertrophy. Am J Physiol Endocrinol Metab. 2015 Dec 15;309(12):E1019-31. doi: 10.1152/ajpendo.00375.2015. Epub 2015 Oct 27.
- The overarching aim of this project is to investigate if vitamin D supplementation can increase muscle mass and strength and to explore if the cellular pathways identified in healthy individualsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to data protection - participants did not agree to IPD
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.
Raquel Revuelta Iniesta, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3000 IU per Day Spray in people with Vitamin D Effects on MPS and Placebo Effects on MPS, run by University of Exeter 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 2 inclusion and 5 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 24 Dec 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fractional synthetic rate of amino acid incorporation into myofibrillar protein (time frame: 12 weeks x 4 time points). 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 NCT06746389, which also lists 12 linked publications.
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 24 Dec 2024.