Clinical trial NCT06965699: The Effect of a Plant-based, Protein-dense Sauce on Essential Amino Acid Concentrations and Gut Fullness in Older Adults
Official title: Testing the Effect of a Plant-based, Protein-dense Sauce (ProSauce) on Metabolic Availability of Essential Amino Acids and Gut Fullness and Satiety in Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malnutrition Elderly
Protein Malnutrition
Keywords: plant-based protein sauce
older adults
amino acid metabolic availability
appetite regulation
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Concentrations of essential amino acids
timeFrame: 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.
Secondary outcomes:
measure: Concentrations of appetite-related gut hormones
timeFrame: 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.
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Joanna Bowtell, Prof
role: PRINCIPAL_INVESTIGATOR
References: