Protein-Energy MalnutritionNCT05512975
FortiPhy: Protein Bioavailability, Satiety and Appetite
A study testing Dairy protein porridge arm and Plant protein porridge arm in people with Protein-Energy Malnutrition, run by University of Reading at 1 site in United Kingdom.
Trial summary
Older adults have very specific food and nutrient requirements and often struggle to meet these needs due to poor appetite, reduced functionality and dexterity. Protein (both quality and quantity) is an important macronutrient in maintaining muscle in older adults which can help prevent falls, delay disease onset and… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Protein-Energy Malnutrition
- What is being tested?
- Dairy protein porridge arm and Plant protein porridge arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Oct 2022to 12 Dec 2024
- Phase
- Interventional
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 70 years or over (no upper age limit), equal number of males and females
- BMI range: 18.5-30kg/m2
- Regularly consume 3 meals a day (with breakfast by 11am, lunch and dinner)
- Able to test the dishes provided
- Able to feed themselves
- Able to provide informed consent
- Understand English
Who cannot join
- Existing neurological or gastrointestinal condition
- Current chewing or swallowing difficulties (such as dysphagia)
- Existing cognitive or psychiatric disorder
- Taking medications that can significantly affect taste changes, appetite or gastric emptying
- On a special or therapeutic diet
- Have any food allergies or intolerances that will be worsened with meals provided in the study
Show all 12Show fewer
- Have a history or drug or alcohol misuse
- Smoke more than 10 cigarettes a day
- Those who score ≤22 on the T-CogS exam
- For participants providing blood samples:
- Anaemia (men: haemoglobin<130 g/L and women <115 g/L)
- Hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom
Reading, RG66UR
About this study
Official title: Evaluation of Protein Bioavailability, Satiety and Appetite Responses to Protein Fortified Porridge in Older Adults
Older adults have very specific food and nutrient requirements and often struggle to meet these needs due to poor appetite, reduced functionality and dexterity. Protein (both quality and quantity) is an important macronutrient in maintaining muscle in older adults which can help prevent falls, delay disease onset and help individuals maintain independence. Fortifying regular/ everyday foods with additional protein is one strategy to help older adults meet these increased protein needs. However, it is well established that protein is the most satiating of the nutrients we eat, yet less is known about how this is impacted by age and protein type. This study aims to test 2 protein fortified porridge recipes in older adults (and a control recipe) with outcomes focused on protein bioavailability, appetite and satiety responses.
Read the detailed description
Older adults have very specific food needs, not just in terms of the nutritional composition, but also because of reduced ability to prepare foods due to reduced functionality and dexterity. Foods may also become less appealing and less palatable with decreases in smell, taste and sight. Older adults often have a smaller appetite due to numerous factors including sensory decline, frailty, reduced activity and delayed gastric emptying. As such, fortified recipes of normal everyday foods can provide palatable familiar foods, that can be easy to prepare, whilst providing sufficient nutrients in a smaller portion size.
Within meals, the quality and quantity of dietary protein plays a significant role in maintaining muscle mass in older adults which can prevent falls and help older adults maintain their independence. Animal-based proteins (such as diary proteins) are complete protein sources that can lead to an improved muscle mass synthesis response compared to plant-based protein. However, it is also well established that protein is the most satiating of the nutrients we eat; yet less is known about how this is effected by age and by protein type. Hence, the addition of protein to a meal may result in an undesirable compensatory decrease in food intake in older adults, which may worsen undernutrition rather than preventing it. This issue is all the more worthwhile to investigate as ageing is known to alter hunger and satiety regulation mechanisms. Gastric emptying and gastrointestinal transit has been shown to delay in older adults. Slower gastric emptying can result in the stomach remaining distended a longer period of time and satiety being maintained. In addition, several studies have demonstrated the presence of higher levels of the hormones that control appetite in older compared to young individuals.
This study will be testing protein fortified porridge, a recipe that has been developed with older adults. It will assess how much of the protein in the meals is absorbed into the body and the impact it has on food intake, appetite, emptying from the stomach and hormones related to appetite. It will compare three recipes: a standard porridge recipe (control), a recipe fortified with milk protein (animal based protein), and a recipe fortified with soya (plant based protein).
- Conditions
- Protein-Energy Malnutrition
- Being tested
- Dairy protein porridge arm, Plant protein porridge arm, Control Porridge arm
- Keywords
- Appetite, Older adults, Protein bioavailability, Satiety
- Medical subject headings
- Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy protein porridge armDietary supplement
Regular porridge ingredients with additional delical whey protein fortification
Plant protein porridge armDietary supplement
Regular porridge ingredients with the addition of extruded soya protein fortification and soya milk instead of regular dairy milk
Control Porridge armDietary supplement
Regular porridge ingredients with no additional protein fortification
| Study group | Role | What they receive |
|---|---|---|
| Control Porridge arm | Experimental | Control/ regular protein porridge recipe, not containing any additional protein fortification. Receives: Dietary Supplement: Control Porridge arm |
| Dairy Protein Porridge arm | Experimental | Porridge containing regular protein ingredients with dairy protein fortification (delical- a whey protein powder) Receives: Dietary Supplement: Dairy protein porridge arm |
| Plant Protein Porridge arm | Experimental | Porridge containing regular protein ingredients with plant protein fortification (extruded soy and soya milk) Receives: Dietary Supplement: Plant protein porridge arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Bioavailability: Do the dairy and soya protein fortified porridge recipes increase protein bioavailability in
Blood samples will be taken every 15-30 minutes following meal ingestion, and protein bioavailability will be determined in the samples using HPLC analysis.
Measured: 15-30 minute intervals for up to 4 hours following meal ingestion. This will be done for all 3 test meals provided to the participant
Secondary outcomes (1)
Appetite rating: Do the dairy and soya protein fortified recipes increase satiety and appetite responses in older adults compared to the non-fortified meals?
Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
Measured: 30 minute intervals for up to 4 hours following meal ingestion. This will be done for all 3 test meals provided to the participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start31 Oct 2022
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Protein-Energy MalnutritionStudies 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
- Model description
- Single group, cross-over design where each participant will consume one of 3 different porridge recipes on separate testing visits. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 3 study visits and all porridges will be provided in a blind manner.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Institute of Food, Fisheries and Aquaculture research (NOFIMA), National Research Institute for Agriculture, Food and environment (INRAE), Biotechnology and Biological Sciences Research Council, European Joint Programming Initiative A Healthy Diet for a Healthy Life (JPI HDHL)
- Responsible party
- Principal investigator, Lisa Methven, University of Reading
- Investigators
- Lisa Methven, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512975
- Sponsor's protocol ID
- UREC 22/20
- Status last verified
- Feb 2025
- First submitted
- 11 Aug 2022
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.
Publications
Norton V, Lignou S, Methven L. Influence of Age and Individual Differences on Mouthfeel Perception of Whey Protein-Fortified Products: A Review. Foods. 2021 Feb 16;10(2):433. doi: 10.3390/foods10020433.
PubMed 33669435Norton V, Lignou S, Bull SP, Gosney MA, Methven L. An Investigation of the Influence of Age and Saliva Flow on the Oral Retention of Whey Protein and Its Potential Effect on the Perception and Acceptance of Whey Protein Beverages. Nutrients. 2020 Aug 19;12(9):2506. doi: 10.3390/nu12092506.
PubMed 32825104Clegg ME, Tarrado Ribes A, Reynolds R, Kliem K, Stergiadis S. A comparative assessment of the nutritional composition of dairy and plant-based dairy alternatives available for sale in the UK and the implications for consumers' dietary intakes. Food Res Int. 2021 Oct;148:110586. doi: 10.1016/j.foodres.2021.110586. Epub 2021 Jul 3.
PubMed 34507731Clegg ME, Williams EA. Optimizing nutrition in older people. Maturitas. 2018 Jun;112:34-38. doi: 10.1016/j.maturitas.2018.04.001. Epub 2018 Apr 4.
PubMed 29704915
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Protein Bioavailability, Satiety and Appetite Responses to Protein Fortified Porridge in Older Adults
- ClinicalTrials.gov ID
- NCT05512975
- Acronym / sponsor ID
- UREC 22/20
- Conditions
- Protein-Energy Malnutrition
- Keywords
- Appetite, Older adults, Protein bioavailability, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- The Norwegian Institute of Food, Fisheries and Aquaculture research (NOFIMA), National Research Institute for Agriculture, Food and environment (INRAE), Biotechnology and Biological Sciences Research Council, European Joint Programming Initiative A Healthy Diet for a Healthy Life (JPI HDHL)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 23 Aug 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.
Older adults have very specific food and nutrient requirements and often struggle to meet these needs due to poor appetite, reduced functionality and dexterity. Protein (both quality and quantity) is an important macronutrient in maintaining muscle in older adults which can help prevent falls, delay disease onset and help individuals maintain independence. Fortifying regular/ everyday foods with additional protein is one strategy to help older adults meet these increased protein needs. However, it is well established that protein is the most satiating of the nutrients we eat, yet less is known about how this is impacted by age and protein type. This study aims to test 2 protein fortified porridge recipes in older adults (and a control recipe) with outcomes focused on protein bioavailability, appetite and satiety responses.
Detailed description
Older adults have very specific food needs, not just in terms of the nutritional composition, but also because of reduced ability to prepare foods due to reduced functionality and dexterity. Foods may also become less appealing and less palatable with decreases in smell, taste and sight. Older adults often have a smaller appetite due to numerous factors including sensory decline, frailty, reduced activity and delayed gastric emptying. As such, fortified recipes of normal everyday foods can provide palatable familiar foods, that can be easy to prepare, whilst providing sufficient nutrients in a smaller portion size.
Within meals, the quality and quantity of dietary protein plays a significant role in maintaining muscle mass in older adults which can prevent falls and help older adults maintain their independence. Animal-based proteins (such as diary proteins) are complete protein sources that can lead to an improved muscle mass synthesis response compared to plant-based protein. However, it is also well established that protein is the most satiating of the nutrients we eat; yet less is known about how this is effected by age and by protein type. Hence, the addition of protein to a meal may result in an undesirable compensatory decrease in food intake in older adults, which may worsen undernutrition rather than preventing it. This issue is all the more worthwhile to investigate as ageing is known to alter hunger and satiety regulation mechanisms. Gastric emptying and gastrointestinal transit has been shown to delay in older adults. Slower gastric emptying can result in the stomach remaining distended a longer period of time and satiety being maintained. In addition, several studies have demonstrated the presence of higher levels of the hormones that control appetite in older compared to young individuals.
This study will be testing protein fortified porridge, a recipe that has been developed with older adults. It will assess how much of the protein in the meals is absorbed into the body and the impact it has on food intake, appetite, emptying from the stomach and hormones related to appetite. It will compare three recipes: a standard porridge recipe (control), a recipe fortified with milk protein (animal based protein), and a recipe fortified with soya (plant based protein).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single group, cross-over design where each participant will consume one of 3 different porridge recipes on separate testing visits. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 3 study visits and all porridges will be provided in a blind manner.
| Arm | Type | Receives |
|---|---|---|
| Control Porridge arm | Experimental | Dietary Supplement: Control Porridge armControl/ regular protein porridge recipe, not containing any additional protein fortification. |
| Dairy Protein Porridge arm | Experimental | Dietary Supplement: Dairy protein porridge armPorridge containing regular protein ingredients with dairy protein fortification (delical- a whey protein powder) |
| Plant Protein Porridge arm | Experimental | Dietary Supplement: Plant protein porridge armPorridge containing regular protein ingredients with plant protein fortification (extruded soy and soya milk) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Aged 70 years or over (no upper age limit), equal number of males and females
- BMI range: 18.5-30kg/m2
- Regularly consume 3 meals a day (with breakfast by 11am, lunch and dinner)
- Able to test the dishes provided
- Able to feed themselves
Key exclusion criteria (12 listed)
- Existing neurological or gastrointestinal condition
- Current chewing or swallowing difficulties (such as dysphagia)
- Existing cognitive or psychiatric disorder
- Taking medications that can significantly affect taste changes, appetite or gastric emptying
- On a special or therapeutic diet
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 |
|---|---|---|
| Dairy protein porridge armRegular porridge ingredients with additional delical whey protein fortification | Dietary supplement | Dairy Protein Porridge arm |
| Plant protein porridge armRegular porridge ingredients with the addition of extruded soya protein fortification and soya milk instead of regular dairy milk | Dietary supplement | Plant Protein Porridge arm |
| Control Porridge armRegular porridge ingredients with no additional protein fortification | Dietary supplement | Control Porridge arm |
Primary outcome
Protein Bioavailability: Do the dairy and soya protein fortified porridge recipes increase protein bioavailability in
Time frame: 15-30 minute intervals for up to 4 hours following meal ingestion. This will be done for all 3 test meals provided to the participant
Blood samples will be taken every 15-30 minutes following meal ingestion, and protein bioavailability will be determined in the samples using HPLC analysis.
1 secondary outcome
Appetite rating: Do the dairy and soya protein fortified recipes increase satiety and appetite responses in older adults compared to the non-fortified meals?
Time frame: 30 minute intervals for up to 4 hours following meal ingestion. This will be done for all 3 test meals provided to the participant
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 17 Feb 2025.
- Background: PubMed 33669435Norton V, Lignou S, Methven L. Influence of Age and Individual Differences on Mouthfeel Perception of Whey Protein-Fortified Products: A Review. Foods. 2021 Feb 16;10(2):433. doi: 10.3390/foods10020433.
- Background: PubMed 32825104Norton V, Lignou S, Bull SP, Gosney MA, Methven L. An Investigation of the Influence of Age and Saliva Flow on the Oral Retention of Whey Protein and Its Potential Effect on the Perception and Acceptance of Whey Protein Beverages. Nutrients. 2020 Aug 19;12(9):2506. doi: 10.3390/nu12092506.
- Background: PubMed 34507731Clegg ME, Tarrado Ribes A, Reynolds R, Kliem K, Stergiadis S. A comparative assessment of the nutritional composition of dairy and plant-based dairy alternatives available for sale in the UK and the implications for consumers' dietary intakes. Food Res Int. 2021 Oct;148:110586. doi: 10.1016/j.foodres.2021.110586. Epub 2021 Jul 3.
- Background: PubMed 29704915Clegg ME, Williams EA. Optimizing nutrition in older people. Maturitas. 2018 Jun;112:34-38. doi: 10.1016/j.maturitas.2018.04.001. Epub 2018 Apr 4.
- Individual participant dataSharing planned: No. No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unliked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.
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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.
Lisa Methven principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy protein porridge arm and Plant protein porridge arm in people with Protein-Energy Malnutrition, run by University of Reading 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 7 inclusion and 12 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 17 Feb 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. 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?
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?
Protein Bioavailability: Do the dairy and soya protein fortified porridge recipes increase protein bioavailability in (time frame: 15-30 minute intervals for up to 4 hours following meal ingestion. This will be done for all 3 test meals provided to the participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05512975, which also lists 4 linked publications.
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 17 Feb 2025.