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NCT Number: NCT06965699

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

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.

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Key information

Conditions

Malnutrition Elderly Kwashiorkor Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Protein Malnutrition Severe Acute Malnutrition

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Exeter

Exeter, Devon, EX44DZ, United Kingdom

Location status: Recruiting

Location contact

Zhuoxiu Jin

CONTACT

[email protected]

07529283410

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ProSauce

Dietary Supplement

10g additional protein from ProSauce

low-protein sauce

Dietary Supplement

Commercially available standard low-protein sauce

Primary outcomes

  1. 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

  1. Concentrations of appetite-related gut hormones

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joanna Bowtell, Prof

CONTACT

Zhuoxiu Jin, Dr

CONTACT

[email protected]

+447529283410

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Official study 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

Acronym: ProSauce

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 11, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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