Essential Amino Acid Supplementation Enhances Post-prandial Amino Acid Availability Following a Standard-protein Breakfast in Older Adults

NCT07754760 | Completed

• 1 other identifier: 96565
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Older Adults Without Any Specific Clinical Condition

Keywords

essential amino acids; aminoacidaemia; muscle protein synthesis; post-prandial amino acids; anabolic resistance; sarcopenia; muscle health

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (pre-supplementation), 15 minutes post-supplementation, and then every 30 minutes for the following 3 hours.

Secondary Outcomes (2)

• Appetite

  Baseline (pre-supplementation), 15 minutes post-supplementation, and every 30 minutes thereafter for the following 3-hours.

• Palatability

  Immediately post-supplementation

Study Arms (3)

Gel A

ACTIVE COMPARATOR

An essential amino acid supplement based on Ispoglou et al. (2016; 2017)'s previous work.

Dietary Supplement: Essential amino acid supplement

Gel B

ACTIVE COMPARATOR

An essential amino acid supplement based on Kobayashi et al. (2010)'s previous work.

Dietary Supplement: Essential amino acid supplement

Placebo

PLACEBO COMPARATOR

An energy matched placebo containing no amino acids.

Dietary Supplement: Placebo

Interventions

Essential amino acid supplement DIETARY_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).

Gel A; Gel B

Placebo DIETARY_SUPPLEMENT

An energy-matched plaecbo supplement containing no amino acids.

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Able and willing to provide written informed consent for the study
• Capable of ingesting the oral supplement

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Leeds Beckett University: lead

Study Sites (1)

Carnegie School of Sport

Leeds, West Yorkshire, LS6 3FH, United Kingdom

Location

Related Publications (14)

• 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.

  PMID: 32664648 BACKGROUND

• Butterworth 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.

  PMID: 30835491 BACKGROUND

• Ispoglou 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.

  PMID: 33315000 BACKGROUND

• Tieland 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.

  PMID: 26610565 BACKGROUND

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  PMID: 24814383 BACKGROUND

• Welch 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.

  PMID: 33098419 BACKGROUND

• Morley 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.

  PMID: 20627179 BACKGROUND

• Drummond 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.

  PMID: 18403916 BACKGROUND

• Bertschi 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.

  PMID: 33060812 BACKGROUND

• Martone 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.

  PMID: 28913934 BACKGROUND

• Beaudart 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.

  PMID: 28251287 BACKGROUND

• De 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.

  PMID: 27126327 BACKGROUND

• Cruz-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.

  PMID: 30312372 BACKGROUND

• Ispoglou 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.

  PMID: 29183324 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Theocharis Ispoglou, PhD

  Leeds Beckett University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader

Model Details: The model is a randomised, double-blind, crossover design

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 10, 2026
• Study Start: June 17, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: August 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)