Protein-Energy Malnutrition Clinical Trial
Official title:
Evaluation of Protein Bioavailability, Satiety and Appetite Responses to Protein Fortified Porridge in Older Adults
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.
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Sensory Science Centre, Department of Food and Nutritional Science, University of Reading, Reading, Berkshire, United Kingdom | Reading |
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) |
United Kingdom,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT03664141 -
Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study)
|
Phase 3 | |
Not yet recruiting |
NCT04628117 -
Effect of Oral Nutritional Supplementation on Oxidative Stress in Protein-energy Wasting Patients With Peritoneal Dialysis
|
N/A | |
Completed |
NCT03712306 -
The (Cost)Effectiveness of Increasing Protein Intake on Physical Funtioning in Older Adults
|
N/A | |
Not yet recruiting |
NCT01981083 -
Egg Albumin-Based Protein Supplement Versus Renal-specific Supplement in Hemodialysis Patients
|
Phase 4 | |
Completed |
NCT00135590 -
Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients
|
N/A | |
Recruiting |
NCT02931812 -
Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation
|
||
Not yet recruiting |
NCT06399250 -
Three Channel Food Concept: the Effect Meal Service on Food Intake During Hospitalization
|
||
Active, not recruiting |
NCT06154161 -
Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
|
N/A | |
Completed |
NCT06058247 -
Reducing In-Hospital and 60-Day Mortality in ICU Patients After Surgery With Strict Nutritional Supplementation
|
N/A | |
Completed |
NCT00069134 -
Study of Antioxidants and Oxidants in Malnourished Children
|
N/A | |
Completed |
NCT00561093 -
Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients
|
Phase 3 | |
Recruiting |
NCT03901742 -
Usefulness of Protein-enriched Infant Formula in Pediatric Intensive Care.
|
N/A | |
Active, not recruiting |
NCT02959125 -
NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
|
N/A | |
Completed |
NCT01259999 -
Energy Dense Formula to People Living in Old Peoples Home
|
N/A |