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Recruiting NCT06965699

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

No phase Interventional Malnutrition Elderly Protein Malnutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ProSauce, low-protein sauce.
Who it may be relevant to
Registry conditions: Malnutrition Elderly, Protein Malnutrition. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Dietary supplement ProSauce
    10g additional protein from ProSauce
  • Dietary supplement low-protein sauce
    Commercially available standard low-protein sauce

Primary outcome measures

  • 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.]
Secondary outcome measures (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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Prevention

Study locations

United Kingdom · 1 center
  • University of Exeter — Exeter

Identifiers

NCT: NCT06965699 · ProSauce Uo

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗