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

NCT ID: NCT06965699

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2026-04-30

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.

Conditions

Malnutrition Elderly; Protein Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ProSauce

Group Type: EXPERIMENTAL

ProSauce

Intervention Type: DIETARY_SUPPLEMENT

10g additional protein from ProSauce

standard sauce

Group Type: PLACEBO_COMPARATOR

low-protein sauce

Intervention Type: DIETARY_SUPPLEMENT

Commercially available standard low-protein sauce

Interventions

ProSauce

10g additional protein from ProSauce

Intervention Type: DIETARY_SUPPLEMENT

low-protein sauce

Commercially available standard low-protein sauce

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Exeter

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Bowtell, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

University of Exeter

Exeter, Devon, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Zhuoxiu Jin, Dr

Role: CONTACT

z.jin3@exeter.ac.uk

+447529283410

Joanna Bowtell, Prof

Role: CONTACT

Facility Contacts

Zhuoxiu Jin

Role: primary

z.jin@lboro.ac.uk

07529283410

Other Identifiers

ProSauce Uo

Identifier Type: -

Identifier Source: org_study_id