FortiPhy: Protein Bioavailability, Satiety and Appetite

NCT05512975 | Completed DMC

• 1 other identifier: UREC 22/20
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Protein-Energy Malnutrition

Keywords

Appetite; Older adults; Protein bioavailability; Satiety

Outcome Measures

Primary Outcomes (1)

• 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 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?

  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 Outcomes (3)

• Gastric emptying

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

• Ratings of palatability

  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)

• Ad-libitum meal consumption

  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)

Study Arms (3)

Control Porridge arm

EXPERIMENTAL

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

Dietary Supplement: Control Porridge arm

Dairy Protein Porridge arm

EXPERIMENTAL

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

Dietary Supplement: Dairy protein porridge arm

Plant Protein Porridge arm

EXPERIMENTAL

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

Dietary Supplement: Plant protein porridge arm

Interventions

Dairy protein porridge arm DIETARY_SUPPLEMENT

Regular porridge ingredients with additional delical whey protein fortification

Dairy Protein Porridge arm

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

Plant Protein Porridge arm

Control Porridge arm DIETARY_SUPPLEMENT

Regular porridge ingredients with no additional protein fortification

Control Porridge arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

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

Reading, RG66UR, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 33669435 BACKGROUND

• 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.

  PMID: 32825104 BACKGROUND

• 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.

  PMID: 34507731 BACKGROUND

• 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.

  PMID: 29704915 BACKGROUND

MeSH Terms

Conditions

Protein-Energy Malnutrition

Condition Hierarchy (Ancestors)

Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Lisa Methven

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded study. All participants will consume 2 fortified meals and 1 placebo/ control meal. All participants will be blinded to the intervention provided
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 23, 2022
• Study Start: October 31, 2022
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)