Skip to main content
OpenTrials
Completed

NCT Number: NCT07754760

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carnegie School of Sport

Leeds, West Yorkshire, LS6 3FH, United Kingdom

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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).

Placebo

Dietary Supplement

An energy-matched plaecbo supplement containing no amino acids.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Appetite

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

    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.

  2. Palatability

    Time frame: Immediately post-supplementation

    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.

Sponsors and collaborators

Lead sponsor

Leeds Beckett University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.