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

U

University of Exeter

Status

Enrolling

Conditions

Protein Malnutrition
Malnutrition Elderly

Treatments

Dietary Supplement: low-protein sauce
Dietary Supplement: ProSauce

Study type

Interventional

Funder types

Other

Identifiers

NCT06965699
ProSauce Uo

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

ProSauce
Experimental group
Treatment:
Dietary Supplement: ProSauce
standard sauce
Placebo Comparator group
Treatment:
Dietary Supplement: low-protein sauce

Trial contacts and locations

1

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Central trial contact

Zhuoxiu Jin, Dr; Joanna Bowtell, Prof

Data sourced from clinicaltrials.gov

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