Malnutrition ElderlyProSauceNCT06965699
The Effect of a Plant-based, Protein-dense Sauce on Essential Amino Acid Concentrations and Gut Fullness in Older Adults
A study testing ProSauce and low-protein sauce in people with Malnutrition Elderly and Protein Malnutrition, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition Elderly, Protein Malnutrition
- What is being tested?
- ProSauce and low-protein sauce
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joanna Bowtell, Prof contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Exeter
Exeter, Devon, EX44DZ
Zhuoxiu Jin, 07529283410, z.jin@lboro.ac.uk
About this study
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
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
- Being tested
- ProSauce, low-protein sauce
- Keywords
- plant-based protein sauce, older adults, amino acid metabolic availability, appetite regulation
- Medical subject headings
- Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProSauceDietary supplement
10g additional protein from ProSauce
low-protein sauceDietary supplement
Commercially available standard low-protein sauce
| Study group | Role | What they receive |
|---|---|---|
| ProSauce | Experimental | Not described Receives: Dietary Supplement: ProSauce |
| standard sauce | Placebo comparator | Not described Receives: Dietary Supplement: low-protein sauce |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of essential amino acids
Baseline and postprandial plasma amino acid concentrations will be measured to provides valuable insights into protein digestion and absorption.
Measured: 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
Plasma appetite-related hormones i.e., acylated ghrelin, PYY, GLP-1, CCK, will be measured at certain time points via cannulation.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start10 Jul 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Bowtell, Prof, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965699
- Sponsor's protocol ID
- ProSauce Uo
- Acronym
- ProSauce
- Status last verified
- Sep 2025
- First submitted
- 23 Apr 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06965699
- Acronym / sponsor ID
- ProSauce / ProSauce Uo
- Conditions
- Malnutrition Elderly, Protein Malnutrition
- Keywords
- plant-based protein sauce, older adults, amino acid metabolic availability, appetite regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProSauce | Experimental | Dietary Supplement: ProSauce |
| standard sauce | Placebo comparator | Dietary Supplement: low-protein sauce |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- Age < 60y
- Smoking
- Food allergies
- Cognitive and mobility issues
- Hospitalisation in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProSauce10g additional protein from ProSauce | Dietary supplement | ProSauce |
| low-protein sauceCommercially available standard low-protein sauce | Dietary supplement | standard sauce |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joanna Bowtell, Prof contact
Joanna Bowtell, Prof principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProSauce and low-protein sauce in people with Malnutrition Elderly and Protein Malnutrition, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhuoxiu Jin, Dr (+447529283410, z.jin3@exeter.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.