- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05512975
FortiPhy: Protein Bioavailability, Satiety and Appetite
Evaluation of Protein Bioavailability, Satiety and Appetite Responses to Protein Fortified Porridge in Older Adults
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lisa Methven
- Phone Number: 44(0)1183788714
- Email: l.methven@reading.ac.uk
Study Locations
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Reading, United Kingdom, RG66UR
- Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control Porridge arm
Control/ regular protein porridge recipe, not containing any additional protein fortification.
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Regular porridge ingredients with no additional protein fortification
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Experimental: Dairy Protein Porridge arm
Porridge containing regular protein ingredients with dairy protein fortification (delical- a whey protein powder)
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Regular porridge ingredients with additional delical whey protein fortification
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Experimental: Plant Protein Porridge arm
Porridge containing regular protein ingredients with plant protein fortification (extruded soy and soya milk)
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Regular porridge ingredients with the addition of extruded soya protein fortification and soya milk instead of regular dairy milk
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Blood samples will be taken every 15-30 minutes following meal ingestion, and protein bioavailability will be determined in the samples using HPLC analysis.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
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30 minute intervals for up to 4 hours following meal ingestion. This will be done for all 3 test meals provided to the participant
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric emptying
Time Frame: 15-30 minute intervals for up to 4 hours following meal ingestion
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Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test
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15-30 minute intervals for up to 4 hours following meal ingestion
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Ratings of palatability
Time Frame: 5 minutes (VAS scales for palatability once following the consumption of the test meal. This will be done for all 3 test meals provided to the participant, on the 3 separate days)
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Palatability ratings are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
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5 minutes (VAS scales for palatability once following the consumption of the test meal. This will be done for all 3 test meals provided to the participant, on the 3 separate days)
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Ad-libitum meal consumption
Time Frame: 20 minutes (consumption of the meal weighed once post consumption. This will be done for all 3 test meals provided to the participant, on the 3 separate days)
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Consumption of the ad-libitum meal is measured (g).
Participants are instructed to eat until they feel comfortable full and are given 20 min to consume the meal.
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20 minutes (consumption of the meal weighed once post consumption. This will be done for all 3 test meals provided to the participant, on the 3 separate days)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- Norton 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.
- Clegg 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.
- Clegg 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UREC 22/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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