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

NCT06965699 | Recruiting

• 1 other identifier: ProSauce Uo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

plant-based protein sauce; older adults; amino acid metabolic availability; appetite regulation

Outcome Measures

Primary Outcomes (1)

• Concentrations of essential amino acids

  Baseline and postprandial plasma amino acid concentrations will be measured to provides valuable insights into protein digestion and absorption.

  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 (1)

• 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.

Study Arms (2)

ProSauce

EXPERIMENTAL

Dietary Supplement: ProSauce

standard sauce

PLACEBO COMPARATOR

Dietary Supplement: low-protein sauce

Interventions

ProSauce DIETARY_SUPPLEMENT

10g additional protein from ProSauce

ProSauce

low-protein sauce DIETARY_SUPPLEMENT

Commercially available standard low-protein sauce

standard sauce

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

University of Exeter

Exeter, Devon, EX44DZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Kwashiorkor

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Joanna Bowtell, Prof

  University of Exeter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuoxiu Jin, Dr

CONTACT

+447529283410; z.jin3@exeter.ac.uk

Joanna Bowtell, Prof

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 11, 2025
• Study Start: July 10, 2025
• Primary Completion: October 30, 2025
• Study Completion: April 30, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)