An interventional study of ProSauce and low-protein sauce in Malnutrition Elderly and Protein Malnutrition, sponsored by University of Exeter. Recruiting at 1 site in United Kingdom. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by University of Exeter · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to determine whether meals fortified with plant-based high protein sauce (ProSauce) provide better metabolic availability of essential amino acids compared to meals with standard lower-protein sauce without resulting in excessive gut fullness and satiety. The main questions it aims to answer are:
Does meals with high-protein sauce deliver better metabolic availability of amino acid profile? Does this high-protein sauce also not lead to excessive appetite suppression due to its liquid form? Researchers will compare high protein sauce to a commercially available standard low protein sauce.
Participants will consume two meals, either protein-fortified or standard low-protein sauce, in a randomised order with at least a one-week washout period between each meal. The investigators will collect venous blood samples over a 6-hour postprandial period to measure plasma essential (and non-essential) amino acid and insulin concentrations. The investigators will also measure appetite-related hormones from venous plasma and assess subjective appetite using a visual analogue scale, taken in parallel with the blood sample time points.
44 studies on the registry are indexed under Kwashiorkor; 6 are open to participants now.
This study's planned enrollment of 20 is below the median of 93 across 32 interventional studies indexed under Kwashiorkor.
Browse Kwashiorkor studies →University of Exeter is the lead sponsor of 138 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: ProSauce
Dietary Supplement: low-protein sauce
10g additional protein from ProSauce
Commercially available standard low-protein sauce
Concentrations of essential amino acids
Baseline and postprandial plasma amino acid concentrations will be measured to provides valuable insights into protein digestion and absorption.
Time frame: Essential amino acid concentrations at time points of baseline, immediately after breakfast (t =0 minute) and t = 20, 40, 60, 90, 120, 180, 240, 300, 360 minutes.
Concentrations of appetite-related gut hormones
Plasma appetite-related hormones i.e., acylated ghrelin, PYY, GLP-1, CCK, will be measured at certain time points via cannulation.
Time frame: Appetite-related gut hormones will be measured at time points of baseline, immediately after breakfast (t =0 minute) and t = 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes.
Plan to share: No
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University of Exeter