The Effect of a Plant-based, Protein-dense Sauce on Essential Amino Acid Concentrations and Gut Fullness in Older Adults

Not Applicable

Not yet recruiting

• Conditions: Malnutrition Elderly; Protein Malnutrition

• Registration Number: NCT06965699
• Lead Sponsor: University of Exeter

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-05-01
• Last Update Submitted: 2025-05-01
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2025-06-01
• Primary Completion: 2025-09-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Exeter; 🇬🇧 Exeter, Devon, United Kingdom