FortiPhy: Protein Bioavailability, Satiety and Appetite

NCT ID: NCT05512975

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2024-12-12

Brief Summary

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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

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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

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Protein-Energy Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Single blinded study. All participants will consume 2 fortified meals and 1 placebo/ control meal. All participants will be blinded to the intervention provided

Study Groups

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Control Porridge arm

Control/ regular protein porridge recipe, not containing any additional protein fortification.

Group Type EXPERIMENTAL

Control Porridge arm

Intervention Type DIETARY_SUPPLEMENT

Regular porridge ingredients with no additional protein fortification

Dairy Protein Porridge arm

Porridge containing regular protein ingredients with dairy protein fortification (delical- a whey protein powder)

Group Type EXPERIMENTAL

Dairy protein porridge arm

Intervention Type DIETARY_SUPPLEMENT

Regular porridge ingredients with additional delical whey protein fortification

Plant Protein Porridge arm

Porridge containing regular protein ingredients with plant protein fortification (extruded soy and soya milk)

Group Type EXPERIMENTAL

Plant protein porridge arm

Intervention Type DIETARY_SUPPLEMENT

Regular porridge ingredients with the addition of extruded soya protein fortification and soya milk instead of regular dairy milk

Interventions

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Dairy protein porridge arm

Regular porridge ingredients with additional delical whey protein fortification

Intervention Type DIETARY_SUPPLEMENT

Plant protein porridge arm

Regular porridge ingredients with the addition of extruded soya protein fortification and soya milk instead of regular dairy milk

Intervention Type DIETARY_SUPPLEMENT

Control Porridge arm

Regular porridge ingredients with no additional protein fortification

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Norwegian Institute of Food, Fisheries and Aquaculture research (NOFIMA)

UNKNOWN

Sponsor Role collaborator

National Research Institute for Agriculture, Food and environment (INRAE)

UNKNOWN

Sponsor Role collaborator

Biotechnology and Biological Sciences Research Council

OTHER

Sponsor Role collaborator

European Joint Programming Initiative A Healthy Diet for a Healthy Life (JPI HDHL)

UNKNOWN

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Lisa Methven

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Methven

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom

Reading, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 33669435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32825104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34507731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29704915 (View on PubMed)

Other Identifiers

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UREC 22/20

Identifier Type: -

Identifier Source: org_study_id

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