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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Exeter
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Concentrations of essential amino acids
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Arms & Interventions
standard sauce
Intervention: low-protein sauce (Dietary Supplement)
ProSauce
Intervention: ProSauce (Dietary Supplement)
Outcomes
Primary Outcomes
Concentrations of essential amino acids
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.
Baseline and postprandial plasma amino acid concentrations will be measured to provides valuable insights into protein digestion and absorption.
Secondary Outcomes
- 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.)