AgingPhase 2NCT05420142
Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products
A Phase 2 study testing Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey in people with Aging and Undernutrition, run by University College Dublin at 2 sites in 2 countries.
Trial summary
This study aims to assess the digestibility and efficacy of the study groups previously developed innovative plant-based protein and fibre products. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Undernutrition, Appetite Loss
- What is being tested?
- Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Mar 2022to 31 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community-dwelling, Age 65+ years, not a heavy smoker (≤10/day), BMI 18-30 kg/m2
Who cannot join
- Medical condition or medication known to impact appetite or energy intake, consumes more than 14 (female) or 21 (male) units of alcohol per week, inability to come to study centre, self-reported cognitive impairment or diagnosis of clinical depression, heavy smoker (>10/day)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
University of Padua Department of Biomedical Science, Neuromuscular Physiology Laboratory
Padova, 35131
About this study
Official title: Innovative plAnt Protein Fibre and Physical Activity Solutions to Address Poor appEtite and prevenT undernutrITion in oldEr Adults (APPETITE): Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products
This study aims to assess the digestibility and efficacy of the study groups previously developed innovative plant-based protein and fibre products.
Read the detailed description
Older people are at high risk of undernutrition, which leads to serious adverse health outcomes, but effective preventive strategies are lacking. Effective, new strategies should focus on the etiology of undernutrition and directly address potential causes and mechanisms underpinning undernutrition.
Reduced food intake and restricted dietary diversity are direct consequences of poor appetite. Recent studies have shown, that older persons with a poor appetite demonstrate lower intake of protein and dietary fibre, and of several nutrient-rich food groups (e.g. meat, fish, wholegrains, vegetables), after adjustment for energy intake and other potential confounders, but a higher consumption of food groups low in micronutrients (e.g. fats, oils, sweets, and sodas), compared to those with good appetite.
Enhancing dietary protein and fibre intake in older Europeans is a key objective because intake of both nutrients is sub- optimal, not only in those with poor appetite. Adequate protein intake prevents excessive decline in muscle mass and function (sarcopenia), a widespread health-issue in older persons, intensified by undernutrition. Adequate dietary fibre intake prevents constipation and impedes the development of many chronic diseases prevalent in older people. Thus, targeting adequate protein and fibre intake may be particularly beneficial in this vulnerable population.
A preparatory short-term study will be performed to assess in 10 healthy older adults the net peripheral Amino Acid (AA) appearance following ingestion of 3 selected Plant-based Proteins and Fibre (PPF) products previously developed by the wider study collaborators, compared to the reference of 30 g whey protein. Plasma concentrations of AA from arterialised blood will be measured by ion exchange chromatography in blood samples (1 drawn before and 6 during 3 hours postprandial). This step will allow the research group to compare in-vitro (previous work) and in-vivo digestibility of several PPF mixtures and identify the product with both optimal amino acid composition and sensory properties as well as optimal post-prandial plasma amino acid profile to be used in further studies.
- Conditions
- Aging, Undernutrition, Appetite Loss, Age-Related Sarcopenia
- Being tested
- Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey
- Keywords
- Amino Acid, Gut hormones, Older adults, Successful ageing, Plant protein, Fibre
- Medical subject headings
- Malnutrition, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Net peripheral AA appearance following ingestion of 3 selected PPF products compared to wheyDietary supplement
The intervention will assess the effects of three difference varieties of plant-based protein and fibre supplements on net peripheral amino acid appearance in blood compared to whey protein with matched fibre content as a control arm.
| Study group | Role | What they receive |
|---|---|---|
| Test meal incorporating the study groups innovative plant protein and fibre (variety 3) product. | Experimental | The standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 65.64g of plant protein and fibre variety 3 (3.09g leucine), 28.6g butter, 5.12g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance. Receives: Dietary Supplement: Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey |
| Test meal incorporating the study groups innovative plant protein and fibre (variety 5) product. | Experimental | The standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 67.78g of plant protein and fibre variety 3 (3.09g leucine), 27.79g butter, 4.63g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance. Receives: Dietary Supplement: Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey |
| Test meal incorporating the study groups innovative plant protein and fibre (variety 6) product. | Experimental | The standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 57.66g of plant protein and fibre variety 3 (3.09g leucine), 31.72g butter, 6.62g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance. Receives: Dietary Supplement: Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey |
| Test meal incorporating the control comparator (whey protein isolates), plus 10g of added pea fibre. | Active comparator | The standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 36.59g of unflavoured Optimum Nutrition gold standard 100% whey protein (3.09g leucine), 33.23g butter, 9.09g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance. Receives: Dietary Supplement: Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute change in amino acid appearance in peripheral blood following a test meal ingestion
Arterialised blood samples will be drawn from antecubital vein and centrifuged at 4˚C for 10 minutes at 4000rpm and frozen at -80˚C until analysed. Samples will be analysed using HPLC methods and expressed in μmol/L.
Measured: Blood samples will be taken at baseline, and at 30, 60, 90, 120, 150, & 180 minutes following ingestion of test sample
Secondary outcomes (2)
Acute changes in appetite and desire to eat
Changes in appetite and are assessed at set time points throughout the testing session, matched for timing of biological sample collection. This will be assessed using the validated visual analogue scale (VAS) method. The Visual Analogue Scale is a 100mm scale with anchors on each end describing extreme answers. On the left side of the scale is the extreme negative response and the right side the positive response. Participants mark the line were appropriate between both extremes.
Measured: baseline, 30, 60, 90, 120, 150, & 180 minutes following ingestion of a sample meal
Sensory properties and palatability of the test meal after ingestion
Participants will rate each test meal on their perceived sensory properties and rate different aspects related to its palatability. These are important considerations when developing new products and will be assessed using the validated visual analogue scale (VAS) method. The Visual Analogue Scale is a 100mm scale with anchors on each end describing extreme answers. On the left side of the scale is the extreme negative response and the right side the positive response. Participants mark the line were appropriate between both extremes.
Measured: Immediately following test meal ingestion (single measure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start14 Mar 2022
- Primary completion12 May 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, University of Padova, Fraunhofer Institute for Interfacial Engineering and Biotechnology
- Responsible party
- Sponsor
- Investigators
- Helen Roche, Prof, Principal investigator, University College DublinKaty Horner, Dr, Principal investigator, University College DublinDominique Dardevet, Dr, Principal investigator, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (INRAE)Giuseppe De Vito, Prof, Principal investigator, University of Padua Department of Biomedical Science, Neuromuscular Physiology Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420142
- Sponsor's protocol ID
- APPETITE_AA3.1
- Status last verified
- Sep 2022
- First submitted
- 4 May 2022
- Last updated
- 26 Sep 2022
- 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 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative plAnt Protein Fibre and Physical Activity Solutions to Address Poor appEtite and prevenT undernutrITion in oldEr Adults (APPETITE): Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products
- ClinicalTrials.gov ID
- NCT05420142
- Acronym / sponsor ID
- APPETITE_AA3.1
- Conditions
- Aging, Undernutrition, Appetite Loss, Age-Related Sarcopenia
- Keywords
- Amino Acid, Gut hormones, Older adults, Successful ageing, Plant protein, Fibre
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, University of Padova, Fraunhofer Institute for Interfacial Engineering and Biotechnology
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 15 Jun 2022 (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.
This study aims to assess the digestibility and efficacy of the study groups previously developed innovative plant-based protein and fibre products.
Detailed description
Older people are at high risk of undernutrition, which leads to serious adverse health outcomes, but effective preventive strategies are lacking. Effective, new strategies should focus on the etiology of undernutrition and directly address potential causes and mechanisms underpinning undernutrition.
Reduced food intake and restricted dietary diversity are direct consequences of poor appetite. Recent studies have shown, that older persons with a poor appetite demonstrate lower intake of protein and dietary fibre, and of several nutrient-rich food groups (e.g. meat, fish, wholegrains, vegetables), after adjustment for energy intake and other potential confounders, but a higher consumption of food groups low in micronutrients (e.g. fats, oils, sweets, and sodas), compared to those with good appetite.
Enhancing dietary protein and fibre intake in older Europeans is a key objective because intake of both nutrients is sub- optimal, not only in those with poor appetite. Adequate protein intake prevents excessive decline in muscle mass and function (sarcopenia), a widespread health-issue in older persons, intensified by undernutrition. Adequate dietary fibre intake prevents constipation and impedes the development of many chronic diseases prevalent in older people. Thus, targeting adequate protein and fibre intake may be particularly beneficial in this vulnerable population.
A preparatory short-term study will be performed to assess in 10 healthy older adults the net peripheral Amino Acid (AA) appearance following ingestion of 3 selected Plant-based Proteins and Fibre (PPF) products previously developed by the wider study collaborators, compared to the reference of 30 g whey protein. Plasma concentrations of AA from arterialised blood will be measured by ion exchange chromatography in blood samples (1 drawn before and 6 during 3 hours postprandial). This step will allow the research group to compare in-vitro (previous work) and in-vivo digestibility of several PPF mixtures and identify the product with both optimal amino acid composition and sensory properties as well as optimal post-prandial plasma amino acid profile to be used in further studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test meal incorporating the study groups innovative plant protein and fibre (variety 3) product. | Experimental | Dietary Supplement: Net peripheral AA appearance following ingestion of 3 selected PPF products compared to wheyThe standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 65.64g of plant protein and fibre variety 3 (3.09g leucine), 28.6g butter, 5.12g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance. |
| Test meal incorporating the study groups innovative plant protein and fibre (variety 5) product. | Experimental | Dietary Supplement: Net peripheral AA appearance following ingestion of 3 selected PPF products compared to wheyThe standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 67.78g of plant protein and fibre variety 3 (3.09g leucine), 27.79g butter, 4.63g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance. |
| Test meal incorporating the study groups innovative plant protein and fibre (variety 6) product. | Experimental | Dietary Supplement: Net peripheral AA appearance following ingestion of 3 selected PPF products compared to wheyThe standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 57.66g of plant protein and fibre variety 3 (3.09g leucine), 31.72g butter, 6.62g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance. |
| Test meal incorporating the control comparator (whey protein isolates), plus 10g of added pea fibre. | Active comparator | Dietary Supplement: Net peripheral AA appearance following ingestion of 3 selected PPF products compared to wheyThe standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 36.59g of unflavoured Optimum Nutrition gold standard 100% whey protein (3.09g leucine), 33.23g butter, 9.09g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Community-dwelling, Age 65+ years, not a heavy smoker (≤10/day), BMI 18-30 kg/m2
Key exclusion criteria (1 listed)
- Medical condition or medication known to impact appetite or energy intake, consumes more than 14 (female) or 21 (male) units of alcohol per week, inability to come to study centre, self-reported cognitive impairment or diagnosis of clinical depression, heavy smoker (>10/day)
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 |
|---|---|---|
| Net peripheral AA appearance following ingestion of 3 selected PPF products compared to wheyThe intervention will assess the effects of three difference varieties of plant-based protein and fibre supplements on net peripheral amino acid appearance in blood compared to whey protein with matched fibre content as a control arm. | Dietary supplement | Test meal incorporating the control comparator (whey protein isolates), plus 10g of added pea fibre., Test meal incorporating the study groups innovative plant protein and fibre (variety 3) product., Test meal incorporating the study groups innovative plant protein and fibre (variety 5) product., Test meal incorporating the study groups innovative plant protein and fibre (variety 6) product. |
Primary outcome
Acute change in amino acid appearance in peripheral blood following a test meal ingestion
Time frame: Blood samples will be taken at baseline, and at 30, 60, 90, 120, 150, & 180 minutes following ingestion of test sample
Arterialised blood samples will be drawn from antecubital vein and centrifuged at 4˚C for 10 minutes at 4000rpm and frozen at -80˚C until analysed. Samples will be analysed using HPLC methods and expressed in μmol/L.
2 secondary outcomes
Acute changes in appetite and desire to eat
Time frame: baseline, 30, 60, 90, 120, 150, & 180 minutes following ingestion of a sample meal
Sensory properties and palatability of the test meal after ingestion
Time frame: Immediately following test meal ingestion (single measure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- 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. This study is not recruiting at the moment.
Helen Roche, Prof principal investigator
University College Dublin
Katy Horner, Dr principal investigator
University College Dublin
Dominique Dardevet, Dr principal investigator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (INRAE)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey in people with Aging and Undernutrition, run by University College Dublin at 2 sites in 2 countries.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland, Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute change in amino acid appearance in peripheral blood following a test meal ingestion (time frame: Blood samples will be taken at baseline, and at 30, 60, 90, 120, 150, & 180 minutes following ingestion of test sample). 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 26 Sep 2022.