FortiPhy: Protein Bioavailability, Satiety and Appetite
Primary Purpose
Protein-Energy Malnutrition
Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dairy protein porridge arm
Plant protein porridge arm
Control Porridge arm
Sponsored by
About this trial
This is an interventional prevention trial for Protein-Energy Malnutrition focused on measuring Appetite, Older adults, Protein bioavailability, Satiety
Eligibility Criteria
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)
Sites / Locations
- Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Control Porridge arm
Dairy Protein Porridge arm
Plant Protein Porridge arm
Arm Description
Control/ regular protein porridge recipe, not containing any additional protein fortification.
Porridge containing regular protein ingredients with dairy protein fortification (delical- a whey protein powder)
Porridge containing regular protein ingredients with plant protein fortification (extruded soy and soya milk)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05512975
First Posted
August 11, 2022
Last Updated
August 21, 2022
Sponsor
University of Reading
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)
1. Study Identification
Unique Protocol Identification Number
NCT05512975
Brief Title
FortiPhy: Protein Bioavailability, Satiety and Appetite
Official Title
Evaluation of Protein Bioavailability, Satiety and Appetite Responses to Protein Fortified Porridge in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading
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)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein-Energy Malnutrition
Keywords
Appetite, Older adults, Protein bioavailability, Satiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Masking Description
Single blinded study. All participants will consume 2 fortified meals and 1 placebo/ control meal. All participants will be blinded to the intervention provided
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Porridge arm
Arm Type
Experimental
Arm Description
Control/ regular protein porridge recipe, not containing any additional protein fortification.
Arm Title
Dairy Protein Porridge arm
Arm Type
Experimental
Arm Description
Porridge containing regular protein ingredients with dairy protein fortification (delical- a whey protein powder)
Arm Title
Plant Protein Porridge arm
Arm Type
Experimental
Arm Description
Porridge containing regular protein ingredients with plant protein fortification (extruded soy and soya milk)
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy protein porridge arm
Intervention Description
Regular porridge ingredients with additional delical whey protein fortification
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant protein porridge arm
Intervention Description
Regular porridge ingredients with the addition of extruded soya protein fortification and soya milk instead of regular dairy milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Porridge arm
Intervention Description
Regular porridge ingredients with no additional protein fortification
Primary Outcome Measure Information:
Title
Protein Bioavailability: Do the dairy and soya protein fortified porridge recipes increase protein bioavailability in
Description
Blood samples will be taken every 15-30 minutes following meal ingestion, and protein bioavailability will be determined in the samples using HPLC analysis.
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
Secondary Outcome Measure Information:
Title
Appetite rating: Do the dairy and soya protein fortified recipes increase satiety and appetite responses in older adults compared to the non-fortified meals?
Description
Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
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
Other Pre-specified Outcome Measures:
Title
Gastric emptying
Description
Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test
Time Frame
15-30 minute intervals for up to 4 hours following meal ingestion
Title
Ratings of palatability
Description
Palatability ratings are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
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)
Title
Ad-libitum meal consumption
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Methven
Phone
44(0)1183788714
Email
l.methven@reading.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Methven
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom
City
Reading
ZIP/Postal Code
RG66UR
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
33669435
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):433. doi: 10.3390/foods10020433.
Results Reference
background
PubMed Identifier
32825104
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):2506. doi: 10.3390/nu12092506.
Results Reference
background
PubMed Identifier
34507731
Citation
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.
Results Reference
background
PubMed Identifier
29704915
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.
Results Reference
background
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FortiPhy: Protein Bioavailability, Satiety and Appetite
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