FortiPhy: Protein Bioavailability, Satiety and Appetite (NCT05512975) | Clinical Trial Compass
CompletedNot Applicable
FortiPhy: Protein Bioavailability, Satiety and Appetite
United Kingdom35 participantsStarted 2022-10-31
Plain-language 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 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.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Protein Bioavailability: Do the dairy and soya protein fortified porridge recipes increase protein bioavailability in
Timeframe: 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