Malnutrition Elderly, Protein Malnutrition
Conditions
Keywords
plant-based protein sauce, older adults, amino acid metabolic availability, appetite regulation
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProSauce
10g additional protein from ProSauce
DIETARY_SUPPLEMENTlow-protein sauce
Commercially available standard low-protein sauce
Sponsors
University of Exeter
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 60 and over * Living independently in the community * Capacity to provide informed consent * Non-smoking (vaping is considered smoking) * No known medical conditions that might influence the study outcomes, e.g., heart disease, diabetes mellitus, obesity, disthyroidism and other endocrinopathies and renal failure * Not taking any medications that might influence the study outcomes e.g., taking anabolic steroids or corticosteroids long term * No clinically diagnosed eating disorders * No severe dislike or allergy to any of the study food * No hospitalisations in the last 6 months * Not dieting and weight stable for 3 months before the study (\< 3 kg change in weight)
Exclusion criteria
* Age \< 60y * Smoking * Food allergies * Cognitive and mobility issues * Hospitalisation in the last 6 months * Known medical conditions that might influence the study outcomes * Taking medications that influence the study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of essential amino acids | 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. | Baseline and postprandial plasma amino acid concentrations will be measured to provides valuable insights into protein digestion and absorption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of appetite-related gut hormones | 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. | Plasma appetite-related hormones i.e., acylated ghrelin, PYY, GLP-1, CCK, will be measured at certain time points via cannulation. |
Countries
United Kingdom
Contacts
Primary ContactZhuoxiu Jin, Dr
Backup ContactJoanna Bowtell, Prof
Outcome results
None listed