Older Adults Without Any Specific Clinical ConditionNCT07754760
Essential Amino Acid Supplementation Enhances Post-prandial Amino Acid Availability Following a Standard-protein Breakfast in Older Adults
A study testing Essential amino acid supplement in people with Older Adults Without Any Specific Clinical Condition, run by Leeds Beckett University at 1 site in United Kingdom.
Trial summary
Healthy older adults and those who have acute and chronic conditions suffer from reduced protein intake and are at risk of developing both chronic and acute sarcopenia. Amino acid supplementation can provide appropriate conditions for muscle protein synthesis to occur. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults Without Any Specific Clinical Condition
- What is being tested?
- Essential amino acid supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jun 2022to 9 Dec 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years or older
- Able and willing to provide written informed consent for the study
- Capable of ingesting the oral supplement
Who cannot join
- Incapable of understanding the study and providing informed consent
- Incapable of ingesting the oral supplement
- Any known cardiovascular disease
- Any known kidney problems or requiring dialysis treatment
- Any known health issue which may affect the uptake and concentration of plasma amino acids
- Suffer from coeliac disease
Show all 9Show fewer
- Being allergic to any of the ingredients in the supplements or standardised breakfast (e.g., nuts and/or oats, wheat, barley, soya)
- Vegan
- Lactose intolerant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Carnegie School of Sport
Leeds, West Yorkshire, LS6 3FH
About this study
Official title: Essential Amino Acid Supplementation Enhances Post-prandial Amino Acid Availability Following a Standard-protein Breakfast in Older Adults: a Randomised Crossover Trial
Healthy older adults and those who have acute and chronic conditions suffer from reduced protein intake and are at risk of developing both chronic and acute sarcopenia. Amino acid supplementation can provide appropriate conditions for muscle protein synthesis to occur. However, the exact amino acid ratio that may optimise this is currently unknown. The purpose of this crossover trial is to compare different amino acid gels and identify which results in the greatest concentration of plasma amino acids following a standardised breakfast. This will allow development of management strategies for healthy and diseased populations who suffer from reduced protein intake.
Read the detailed description
Sarcopenia refers to a skeletal muscle disorder via loss of muscle strength, mass and function that naturally progresses with age. More recently however, the phenomenon of acute sarcopenia (AS) has been suggested which refers to sarcopenia that occurs within a period of six months. This rapid deterioration of muscle, which typically occurs as a result of an illness or stressor, significantly increases the risk of hospital admission, loss of independence, and mortality making it an important target for future research.
Poor nutrition and specifically inadequate energy and dietary protein intakes are contributors to the development of both sarcopenia and AS. Therefore, addressing energy and protein deficiencies have been proposed in review papers as a means to prevent and/or better manage sarcopenia and AS. This is not something that has been explicitly investigated within this specific clinical population to date. Nutritional interventions which are focused on addressing total energy and protein deficiencies will optimise skeletal muscle adaptations via essential amino acids, particularly Leucine, found in protein acting as an important anabolic stimulus for the mammalian target of rapamycin (mTOR). Therefore, this type of management strategy should be able to attenuate the muscle wasting and exacerbated life outcomes (mortality, loss of independence, frailty) that occurs in AS and among other serious health conditions.
Older populations require approximately 30-40g of protein per meal ( ̴0.45 g/kg/BM/Day), with particular importance of leucine, in order to achieve recent recommended daily amounts of 1.2-1.6g/kg/BM/day but this is difficult to achieve in the older population which naturally suffers from a reduced appetite and increased perception of fullness. Breakfast and lunch commonly suffer from the greatest deficiency in protein intake and Ispoglou et al. have developed effective ways in which to increase dietary protein intake without affecting hunger.
The gels which Ispoglou et al. have developed contain 7.5g of essential amino acids (EAAs) per sachet of 65 ml volume each, the equivalent found in 15g of high-quality protein (3g of leucine), and the addition of one of these gels alongside a meal could potentially assist older adults to reach optimal protein requirements on a per meal and daily basis. Previously, supplementation with EAAs has shown to be effective in increasing functional performance and lean tissue mass, while it has been proposed as a potential nutritional therapy for addressing sarcopenia. These EAA gels also do not affect appetite in older adults and have been shown to be an effective means for enhancing both protein and energy intake in older adults.
Supplementation with such gels, as we have shown, can increase plasma concentrations of essential amino acids (AAs), such as leucine, which in turn can act as anabolic stimuli and enhance muscle protein synthesis and potentially prevent or minimise muscle wasting. Plasma concentrations of amino acids, in particular leucine, drives muscle protein synthesis however an excessive concentration of leucine can increase oxidation rates of other essential amino acids, in particular L-isoleucine and L-valine, meaning there is lower plasma availability for muscle protein synthesis. Thus, it is important to identify which AA ratio can maximise the potential for muscle protein synthesis rather than increase oxidation of AAs and limit muscle protein synthesis.
This study will evaluate the plasma concentration of AAs following ingestion of gels with different AA ratios following a standardised breakfast meal. Gel A is based on a formulation devised by Ispoglou et al. and Gel B based on a formulation devised by Kobayashi et al. Therefore, the primary outcome measure is the plasma concentration of essential AAs.
The hypothesis is that the AA supplements will increase plasma AA concentrations versus the placebo, and the different AA ratios may result in different concentrations of plasma AAs.
The main research question for this study will be:
- Which of the gel formulas (Gel A, Gel B, or placebo) will provide the greatest plasma concentrations of AAs?
- Being tested
- Essential amino acid supplement, Placebo
- Keywords
- essential amino acids, aminoacidaemia, muscle protein synthesis, post-prandial amino acids, anabolic resistance, sarcopenia, muscle health
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential amino acid supplementDietary supplement
Two active comparators containing a unique composition of essential amino acids reported previously by Ispoglou et al. (2016; 2017) and Kobayashi et al. (2010).
PlaceboDietary supplement
An energy-matched plaecbo supplement containing no amino acids.
| Study group | Role | What they receive |
|---|---|---|
| Gel A | Active comparator | An essential amino acid supplement based on Ispoglou et al. (2016; 2017)'s previous work. Receives: Dietary Supplement: Essential amino acid supplement |
| Gel B | Active comparator | An essential amino acid supplement based on Kobayashi et al. (2010)'s previous work. Receives: Dietary Supplement: Essential amino acid supplement |
| Placebo | Placebo comparator | An energy matched placebo containing no amino acids. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acid concentration
A series of blood samples collected prior to and post-supplementation were assessed using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods to accurately quantify the plasma concentrations of 15 amino acids. This allowed individual amino acid analysis as well as grouped analysis of non-essential, essential, and branched-chain amino acids.
Measured: Baseline (pre-supplementation), 15 minutes post-supplementation, and then every 30 minutes for the following 3 hours.
Secondary outcomes (2)
Appetite
Using visual analogue scales, feelings of hunger and appetite were recorded throughout the observation period in line with the timings of the blood samples. The scales assessed feelings of hunger, appetite, satiety, and fullness and a desire for sweet, salty, fatty or savoury. This was assessed on a 100mm line where the participant would mark their feelings. A score closer to 100mm indicated a stronger sensation of the metric in question.
Measured: Baseline (pre-supplementation), 15 minutes post-supplementation, and every 30 minutes thereafter for the following 3-hours.
Palatability
Palatability of each supplement was assessed using visual analogue scales. The scale considered visual appeal, smell, taste, aftertaste, and overall palatability. This was assessed on a 100mm line where the participant would mark their feelings. A score closer to 100mm indicated a stronger sensation of the metric in question.
Measured: Immediately post-supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start17 Jun 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Older Adults Without Any Specific Clinical ConditionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The model is a randomised, double-blind, crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leeds Beckett University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonis Stavropoulos-Kalinoglou, Leeds Beckett University
- Investigators
- Theocharis Ispoglou, PhD, Study chair, Leeds Beckett University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754760
- Sponsor's protocol ID
- 96565
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be grouped before analysis and reported in an anonymised manner.
Publications
Lees MJ, Wilson OJ, Webb EK, Traylor DA, Prior T, Elia A, Harlow PS, Black AD, Parker PJ, Harris N, Cooke M, Balchin C, Butterworth M, Phillips SM, Ispoglou T. Novel Essential Amino Acid Supplements Following Resistance Exercise Induce Aminoacidemia and Enhance Anabolic Signaling Irrespective of Age: A Proof-of-Concept Trial. Nutrients. 2020 Jul 12;12(7):2067. doi: 10.3390/nu12072067.
PubMed 32664648Butterworth M, Lees M, Harlow P, Hind K, Duckworth L, Ispoglou T. Alphacute effects of essential amino acid gel-based and whey protein supplements on appetite and energy intake in older women. Appl Physiol Nutr Metab. 2019 Nov;44(11):1141-1149. doi: 10.1139/apnm-2018-0650. Epub 2019 Mar 5.
PubMed 30835491Ispoglou T, Witard OC, Duckworth LC, Lees MJ. The efficacy of essential amino acid supplementation for augmenting dietary protein intake in older adults: implications for skeletal muscle mass, strength and function. Proc Nutr Soc. 2021 May;80(2):230-242. doi: 10.1017/S0029665120008010. Epub 2020 Dec 14.
PubMed 33315000Tieland M, Borgonjen-Van den Berg KJ, Van Loon LJ, de Groot LC. Dietary Protein Intake in Dutch Elderly People: A Focus on Protein Sources. Nutrients. 2015 Nov 25;7(12):9697-706. doi: 10.3390/nu7125496.
PubMed 26610565Deutz NE, Bauer JM, Barazzoni R, Biolo G, Boirie Y, Bosy-Westphal A, Cederholm T, Cruz-Jentoft A, Krznaric Z, Nair KS, Singer P, Teta D, Tipton K, Calder PC. Protein intake and exercise for optimal muscle function with aging: recommendations from the ESPEN Expert Group. Clin Nutr. 2014 Dec;33(6):929-36. doi: 10.1016/j.clnu.2014.04.007. Epub 2014 Apr 24.
PubMed 24814383Welch C, Majid Z, Greig C, Gladman J, Masud T, Jackson T. Interventions to ameliorate reductions in muscle quantity and function in hospitalised older adults: a systematic review towards acute sarcopenia treatment. Age Ageing. 2021 Feb 26;50(2):394-404. doi: 10.1093/ageing/afaa209.
PubMed 33098419Morley JE, Argiles JM, Evans WJ, Bhasin S, Cella D, Deutz NE, Doehner W, Fearon KC, Ferrucci L, Hellerstein MK, Kalantar-Zadeh K, Lochs H, MacDonald N, Mulligan K, Muscaritoli M, Ponikowski P, Posthauer ME, Rossi Fanelli F, Schambelan M, Schols AM, Schuster MW, Anker SD; Society for Sarcopenia, Cachexia, and Wasting Disease. Nutritional recommendations for the management of sarcopenia. J Am Med Dir Assoc. 2010 Jul;11(6):391-6. doi: 10.1016/j.jamda.2010.04.014.
PubMed 20627179Drummond MJ, Rasmussen BB. Leucine-enriched nutrients and the regulation of mammalian target of rapamycin signalling and human skeletal muscle protein synthesis. Curr Opin Clin Nutr Metab Care. 2008 May;11(3):222-6. doi: 10.1097/MCO.0b013e3282fa17fb.
PubMed 18403916Bertschi D, Kiss CM, Beerli N, Kressig RW. Sarcopenia in hospitalized geriatric patients: insights into prevalence and associated parameters using new EWGSOP2 guidelines. Eur J Clin Nutr. 2021 Apr;75(4):653-660. doi: 10.1038/s41430-020-00780-7. Epub 2020 Oct 15.
PubMed 33060812Martone AM, Bianchi L, Abete P, Bellelli G, Bo M, Cherubini A, Corica F, Di Bari M, Maggio M, Manca GM, Marzetti E, Rizzo MR, Rossi A, Volpato S, Landi F. The incidence of sarcopenia among hospitalized older patients: results from the Glisten study. J Cachexia Sarcopenia Muscle. 2017 Dec;8(6):907-914. doi: 10.1002/jcsm.12224. Epub 2017 Sep 14.
PubMed 28913934Beaudart C, Dawson A, Shaw SC, Harvey NC, Kanis JA, Binkley N, Reginster JY, Chapurlat R, Chan DC, Bruyere O, Rizzoli R, Cooper C, Dennison EM; IOF-ESCEO Sarcopenia Working Group. Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review. Osteoporos Int. 2017 Jun;28(6):1817-1833. doi: 10.1007/s00198-017-3980-9. Epub 2017 Mar 1.
PubMed 28251287De Buyser SL, Petrovic M, Taes YE, Toye KR, Kaufman JM, Lapauw B, Goemaere S. Validation of the FNIH sarcopenia criteria and SOF frailty index as predictors of long-term mortality in ambulatory older men. Age Ageing. 2016 Sep;45(5):602-8. doi: 10.1093/ageing/afw071. Epub 2016 Apr 28.
PubMed 27126327Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Ispoglou T, Deighton K, King RF, White H, Lees M. Novel essential amino acid supplements enriched with L-leucine facilitate increased protein and energy intakes in older women: a randomised controlled trial. Nutr J. 2017 Nov 28;16(1):75. doi: 10.1186/s12937-017-0298-6.
PubMed 29183324
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Amino Acid Supplementation Enhances Post-prandial Amino Acid Availability Following a Standard-protein Breakfast in Older Adults: a Randomised Crossover Trial
- ClinicalTrials.gov ID
- NCT07754760
- Acronym / sponsor ID
- 96565
- Keywords
- essential amino acids, aminoacidaemia, muscle protein synthesis, post-prandial amino acids, anabolic resistance, sarcopenia, muscle health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Leeds Beckett UniversityUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 10 Aug 2026 (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.
Healthy older adults and those who have acute and chronic conditions suffer from reduced protein intake and are at risk of developing both chronic and acute sarcopenia. Amino acid supplementation can provide appropriate conditions for muscle protein synthesis to occur. However, the exact amino acid ratio that may optimise this is currently unknown. The purpose of this crossover trial is to compare different amino acid gels and identify which results in the greatest concentration of plasma amino acids following a standardised breakfast. This will allow development of management strategies for healthy and diseased populations who suffer from reduced protein intake.
Detailed description
Sarcopenia refers to a skeletal muscle disorder via loss of muscle strength, mass and function that naturally progresses with age. More recently however, the phenomenon of acute sarcopenia (AS) has been suggested which refers to sarcopenia that occurs within a period of six months. This rapid deterioration of muscle, which typically occurs as a result of an illness or stressor, significantly increases the risk of hospital admission, loss of independence, and mortality making it an important target for future research.
Poor nutrition and specifically inadequate energy and dietary protein intakes are contributors to the development of both sarcopenia and AS. Therefore, addressing energy and protein deficiencies have been proposed in review papers as a means to prevent and/or better manage sarcopenia and AS. This is not something that has been explicitly investigated within this specific clinical population to date. Nutritional interventions which are focused on addressing total energy and protein deficiencies will optimise skeletal muscle adaptations via essential amino acids, particularly Leucine, found in protein acting as an important anabolic stimulus for the mammalian target of rapamycin (mTOR). Therefore, this type of management strategy should be able to attenuate the muscle wasting and exacerbated life outcomes (mortality, loss of independence, frailty) that occurs in AS and among other serious health conditions.
Older populations require approximately 30-40g of protein per meal ( ̴0.45 g/kg/BM/Day), with particular importance of leucine, in order to achieve recent recommended daily amounts of 1.2-1.6g/kg/BM/day but this is difficult to achieve in the older population which naturally suffers from a reduced appetite and increased perception of fullness. Breakfast and lunch commonly suffer from the greatest deficiency in protein intake and Ispoglou et al. have developed effective ways in which to increase dietary protein intake without affecting hunger.
The gels which Ispoglou et al. have developed contain 7.5g of essential amino acids (EAAs) per sachet of 65 ml volume each, the equivalent found in 15g of high-quality protein (3g of leucine), and the addition of one of these gels alongside a meal could potentially assist older adults to reach optimal protein requirements on a per meal and daily basis. Previously, supplementation with EAAs has shown to be effective in increasing functional performance and lean tissue mass, while it has been proposed as a potential nutritional therapy for addressing sarcopenia. These EAA gels also do not affect appetite in older adults and have been shown to be an effective means for enhancing both protein and energy intake in older adults.
Supplementation with such gels, as we have shown, can increase plasma concentrations of essential amino acids (AAs), such as leucine, which in turn can act as anabolic stimuli and enhance muscle protein synthesis and potentially prevent or minimise muscle wasting. Plasma concentrations of amino acids, in particular leucine, drives muscle protein synthesis however an excessive concentration of leucine can increase oxidation rates of other essential amino acids, in particular L-isoleucine and L-valine, meaning there is lower plasma availability for muscle protein synthesis. Thus, it is important to identify which AA ratio can maximise the potential for muscle protein synthesis rather than increase oxidation of AAs and limit muscle protein synthesis.
This study will evaluate the plasma concentration of AAs following ingestion of gels with different AA ratios following a standardised breakfast meal. Gel A is based on a formulation devised by Ispoglou et al. and Gel B based on a formulation devised by Kobayashi et al. Therefore, the primary outcome measure is the plasma concentration of essential AAs.
The hypothesis is that the AA supplements will increase plasma AA concentrations versus the placebo, and the different AA ratios may result in different concentrations of plasma AAs.
The main research question for this study will be:
- Which of the gel formulas (Gel A, Gel B, or placebo) will provide the greatest plasma concentrations of AAs?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The model is a randomised, double-blind, crossover design
| Arm | Type | Receives |
|---|---|---|
| Gel A | Active comparator | Dietary Supplement: Essential amino acid supplementAn essential amino acid supplement based on Ispoglou et al. (2016; 2017)'s previous work. |
| Gel B | Active comparator | Dietary Supplement: Essential amino acid supplementAn essential amino acid supplement based on Kobayashi et al. (2010)'s previous work. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAn energy matched placebo containing no amino acids. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years or older
- Able and willing to provide written informed consent for the study
- Capable of ingesting the oral supplement
Key exclusion criteria (9 listed)
- Incapable of understanding the study and providing informed consent
- Incapable of ingesting the oral supplement
- Any known cardiovascular disease
- Any known kidney problems or requiring dialysis treatment
- Any known health issue which may affect the uptake and concentration of plasma amino acids
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 |
|---|---|---|
| Essential amino acid supplementTwo active comparators containing a unique composition of essential amino acids reported previously by Ispoglou et al. (2016; 2017) and Kobayashi et al. (2010). | Dietary supplement | Gel A, Gel B |
| PlaceboAn energy-matched plaecbo supplement containing no amino acids. | Dietary supplement | Placebo |
Primary outcome
Plasma amino acid concentration
Time frame: Baseline (pre-supplementation), 15 minutes post-supplementation, and then every 30 minutes for the following 3 hours.
A series of blood samples collected prior to and post-supplementation were assessed using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods to accurately quantify the plasma concentrations of 15 amino acids. This allowed individual amino acid analysis as well as grouped analysis of non-essential, essential, and branched-chain amino acids.
2 secondary outcomes
Appetite
Time frame: Baseline (pre-supplementation), 15 minutes post-supplementation, and every 30 minutes thereafter for the following 3-hours.
Palatability
Time frame: Immediately post-supplementation
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 10 Aug 2026.
- Background: PubMed 32664648Lees MJ, Wilson OJ, Webb EK, Traylor DA, Prior T, Elia A, Harlow PS, Black AD, Parker PJ, Harris N, Cooke M, Balchin C, Butterworth M, Phillips SM, Ispoglou T. Novel Essential Amino Acid Supplements Following Resistance Exercise Induce Aminoacidemia and Enhance Anabolic Signaling Irrespective of Age: A Proof-of-Concept Trial. Nutrients. 2020 Jul 12;12(7):2067. doi: 10.3390/nu12072067.
- Background: PubMed 30835491Butterworth M, Lees M, Harlow P, Hind K, Duckworth L, Ispoglou T. Alphacute effects of essential amino acid gel-based and whey protein supplements on appetite and energy intake in older women. Appl Physiol Nutr Metab. 2019 Nov;44(11):1141-1149. doi: 10.1139/apnm-2018-0650. Epub 2019 Mar 5.
- Background: PubMed 33315000Ispoglou T, Witard OC, Duckworth LC, Lees MJ. The efficacy of essential amino acid supplementation for augmenting dietary protein intake in older adults: implications for skeletal muscle mass, strength and function. Proc Nutr Soc. 2021 May;80(2):230-242. doi: 10.1017/S0029665120008010. Epub 2020 Dec 14.
- Background: PubMed 26610565Tieland M, Borgonjen-Van den Berg KJ, Van Loon LJ, de Groot LC. Dietary Protein Intake in Dutch Elderly People: A Focus on Protein Sources. Nutrients. 2015 Nov 25;7(12):9697-706. doi: 10.3390/nu7125496.
- Background: PubMed 24814383Deutz NE, Bauer JM, Barazzoni R, Biolo G, Boirie Y, Bosy-Westphal A, Cederholm T, Cruz-Jentoft A, Krznaric Z, Nair KS, Singer P, Teta D, Tipton K, Calder PC. Protein intake and exercise for optimal muscle function with aging: recommendations from the ESPEN Expert Group. Clin Nutr. 2014 Dec;33(6):929-36. doi: 10.1016/j.clnu.2014.04.007. Epub 2014 Apr 24.
- Background: PubMed 33098419Welch C, Majid Z, Greig C, Gladman J, Masud T, Jackson T. Interventions to ameliorate reductions in muscle quantity and function in hospitalised older adults: a systematic review towards acute sarcopenia treatment. Age Ageing. 2021 Feb 26;50(2):394-404. doi: 10.1093/ageing/afaa209.
- Background: PubMed 20627179Morley JE, Argiles JM, Evans WJ, Bhasin S, Cella D, Deutz NE, Doehner W, Fearon KC, Ferrucci L, Hellerstein MK, Kalantar-Zadeh K, Lochs H, MacDonald N, Mulligan K, Muscaritoli M, Ponikowski P, Posthauer ME, Rossi Fanelli F, Schambelan M, Schols AM, Schuster MW, Anker SD; Society for Sarcopenia, Cachexia, and Wasting Disease. Nutritional recommendations for the management of sarcopenia. J Am Med Dir Assoc. 2010 Jul;11(6):391-6. doi: 10.1016/j.jamda.2010.04.014.
- Background: PubMed 18403916Drummond MJ, Rasmussen BB. Leucine-enriched nutrients and the regulation of mammalian target of rapamycin signalling and human skeletal muscle protein synthesis. Curr Opin Clin Nutr Metab Care. 2008 May;11(3):222-6. doi: 10.1097/MCO.0b013e3282fa17fb.
- Background: PubMed 33060812Bertschi D, Kiss CM, Beerli N, Kressig RW. Sarcopenia in hospitalized geriatric patients: insights into prevalence and associated parameters using new EWGSOP2 guidelines. Eur J Clin Nutr. 2021 Apr;75(4):653-660. doi: 10.1038/s41430-020-00780-7. Epub 2020 Oct 15.
- Background: PubMed 28913934Martone AM, Bianchi L, Abete P, Bellelli G, Bo M, Cherubini A, Corica F, Di Bari M, Maggio M, Manca GM, Marzetti E, Rizzo MR, Rossi A, Volpato S, Landi F. The incidence of sarcopenia among hospitalized older patients: results from the Glisten study. J Cachexia Sarcopenia Muscle. 2017 Dec;8(6):907-914. doi: 10.1002/jcsm.12224. Epub 2017 Sep 14.
- Background: PubMed 28251287Beaudart C, Dawson A, Shaw SC, Harvey NC, Kanis JA, Binkley N, Reginster JY, Chapurlat R, Chan DC, Bruyere O, Rizzoli R, Cooper C, Dennison EM; IOF-ESCEO Sarcopenia Working Group. Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review. Osteoporos Int. 2017 Jun;28(6):1817-1833. doi: 10.1007/s00198-017-3980-9. Epub 2017 Mar 1.
- Background: PubMed 27126327De Buyser SL, Petrovic M, Taes YE, Toye KR, Kaufman JM, Lapauw B, Goemaere S. Validation of the FNIH sarcopenia criteria and SOF frailty index as predictors of long-term mortality in ambulatory older men. Age Ageing. 2016 Sep;45(5):602-8. doi: 10.1093/ageing/afw071. Epub 2016 Apr 28.
- Individual participant dataSharing planned: No. Participant data will be grouped before analysis and reported in an anonymised manner.
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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.
Theocharis Ispoglou, PhD study chair
Leeds Beckett University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential amino acid supplement in people with Older Adults Without Any Specific Clinical Condition, run by Leeds Beckett University 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 9 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 10 Aug 2026. 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.
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?
Plasma amino acid concentration (time frame: Baseline (pre-supplementation), 15 minutes post-supplementation, and then every 30 minutes for the following 3 hours.). 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 NCT07754760, which also lists 14 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 10 Aug 2026.