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Completed

NCT Number: NCT05512975

FortiPhy: Protein Bioavailability, Satiety and Appetite

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Reading, RG66UR, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dairy protein porridge arm

Dietary Supplement

Regular porridge ingredients with additional delical whey protein fortification

Plant protein porridge arm

Dietary Supplement

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

Control Porridge arm

Dietary Supplement

Regular porridge ingredients with no additional protein fortification

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).

Other outcomes

  1. Gastric emptying

    Time frame: 15-30 minute intervals for up to 4 hours following meal ingestion

    Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test

  2. 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)

    Palatability ratings are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).

  3. 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)

    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.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • 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)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2022
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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