FortiPhy: Protein Bioavailability, Satiety and Appetite

Protein-Energy Malnutrition Clinical Trial

Official title:

Evaluation of Protein Bioavailability, Satiety and Appetite Responses to Protein Fortified Porridge in Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05512975
• Other study ID #: UREC 22/20
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2022
• Source: University of Reading
• Contact: Lisa Methven
• Phone: 44(0)1183788714
• Email: l.methven[@]reading.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: July 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Malnutrition
• Protein-Energy Malnutrition

Intervention

Dietary Supplement:
• Dairy protein porridge arm
Regular porridge ingredients with additional delical whey protein fortification
• Plant protein porridge arm
Regular porridge ingredients with the addition of extruded soya protein fortification and soya milk instead of regular dairy milk
• Control Porridge arm
Regular porridge ingredients with no additional protein fortification

Locations

Country	Name	City	State
United Kingdom	Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom	Reading

Sponsors (5)

Lead Sponsor	Collaborator
University of Reading	Biotechnology and Biological Sciences Research Council, European Joint Programming Initiative A Healthy Diet for a Healthy Life (JPI HDHL), National Research Institute for Agriculture, Food and environment (INRAE), The Norwegian Institute of Food, Fisheries and Aquaculture research (NOFIMA)

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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). pii: E2506. doi: 10.3390/nu12092506. — View Citation

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). pii: 433. doi: 10.3390/foods10020433. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gastric emptying	Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test	15-30 minute intervals for up to 4 hours following meal ingestion
Other	Ratings of palatability	Palatability ratings are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).	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)
Other	Ad-libitum meal consumption	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.	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)
Primary	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.	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	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).	30 minute intervals for up to 4 hours following meal ingestion. This will be done for all 3 test meals provided to the participant