NCT06965699 The Effect of a Plant-based, Protein-dense Sauce on Essential Amino Acid Concentrations and Gut Fullness in Older Adults
| NCT ID | NCT06965699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Exeter |
| Condition | Malnutrition Elderly |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-07-10 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Joanna Bowtell, Prof
PRINCIPAL INVESTIGATOR
University of Exeter
Frequently Asked Questions
Who can join the NCT06965699 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Malnutrition Elderly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06965699 currently recruiting?
Yes, NCT06965699 is actively recruiting participants. Contact the research team at z.jin3@exeter.ac.uk for enrollment information.
Where is the NCT06965699 trial being conducted?
This trial is being conducted at Exeter, United Kingdom.
Who is sponsoring the NCT06965699 clinical trial?
NCT06965699 is sponsored by University of Exeter. The principal investigator is Joanna Bowtell, Prof at University of Exeter. The trial plans to enroll 20 participants.