Effects of innovative plant protein fibre and physical activity on appetite and incidence of undernutrition in older adults.
What is this research about?
This study will investigate whether an innovative Plant Protein and Fibre (PPF) supplement alone or combined with physical activity can increase appetite, reduce incidence of undernutrition, and improve health in adults aged over 65 years.
Why are we doing this study?
Dietary protein and fibre are critical nutrients for older adults, and enhancing their intake is vital to preventing undernutrition and maintaining organ function and overall health.
Eating animal proteins (e.g., milk and beef) boosts muscle building to a greater extent than eating plant-based proteins (such as rice, pea or soy protein) in older adults. Plant-based proteins are known to be poorly digested, compared with animal-based proteins. However, eating plant-based proteins is better for the environment. Furthermore, exploiting the best from various types of plant proteins into an innovative product with a more desirable nutrient profile may serve as an effective strategy in combating undernutrition in an ageing population. Physical activity is an important factor of maintaining muscle mass at all stages in life, and is also independently related to appetite.
This study aims to find out if a newly developed innovative plant protein and fibre product alone or combined with physical activity can increase appetite, reduce incidence of undernutrition, and improve health in older adults.
Why have you been invited to take part
You have been invited to participate because you:
Are aged 65 years or older.
Are community-dwelling (without assistance)
Occasionally lack appetite (Assessed during screening)
Have a BMI of 20-28kg/m2
Have no medical conditions that impact appetite/taste and not be taking any medication known to impact appetite or taste
Are not a heavy smoker (<10 per day)
Mobile (ability to walk unaided or with a cane)
Other inclusion criteria also apply. If you are interested in participating in this trial, your full eligibility will be assessed during a screening visit.
How will your data be used?
The information gathered from the study will be used to generate information regarding how a personalised diet including plant proteins and fibre, combined with structured physical activity can affect appetite and health outcomes. The data may also be used to write a scientific article which will be published in a scientific journal. Data collected will be de-identified and made anonymous and will not be traceable back to individual participants. The anonymised data will also be shared with our partner universities through secure pathways, in accordance with our data management plan.
What will happen if you decide to take part in this research study?
After reading this information leaflet thoroughly and getting satisfactory answers to your questions if you subsequently wish to participate, please contact the lead researcher Brian Mullen for a pre-screening talk over the phone using the contact details outlined below. You will be asked to answer several screening questions to check you are eligible to participate in the study. If you are eligible based on the screening questions, you will be invited to meet with us in UCD. Prior to each visit you will be asked to complete a COVID-19 symptom questionnaire by email/telephone to ensure you are free of symptoms. At this first visit (visit 1), we will confirm your eligibility. We will also go through the study in detail with you and answer any questions you may have.
If you are happy to proceed in the study, you will then be asked to attend for two separate testing sessions in UCD before and after a 12-week intervention (see diagram below). These will take place during the week prior to commencing the intervention and in the week immediately after the intervention. Measures of body composition, energy expenditure, appetite, blood hormone levels, strength, cardiovascular fitness and urine and faecal samples will be taken. The 12-week intervention will involve being randomly assigned to either a personalised diet including daily plant protein/fibre supplementation and/or physical activity, or a control group.
Screening Visit (Visit 1)
During the eligibility visit we will measure your height and weight, ask you to complete questionnaires regarding your appetite and physical activity and ensure you match the inclusion/exclusion criteria and answer any further questions you may have. This visit should last no longer than 30 minutes. If you are eligible, we will arrange dates with you for your next test sessions, and when you will start the intervention.
Baseline measurements (Visit 2 – approximately 2.5 hours)
Approximately one week prior to commencing the intervention, you will be scheduled for baseline tests. You are asked to come into the Institute of Sport and Health at UCD in the morning in a fasted state (without eating or drinking anything other than water since the night before). The following measurements will be taken:
Body Composition: We will measure your body weight and height. We will also measure your body composition using bioelectrical impedance analysis (BIA) and Dual-energy X-ray Absorptiometry (DXA). For the BIA, you will stand upright in bare feet on the BIA and a very low, pain-free, and safe electrical signal will be sent through your feet to the rest of your body. For the DXA scan, you will be asked to lie-down on a comfortable bed and remain still while the scanner arm passes slowly over your body. The scan takes less than 10 minutes.
Resting Energy Requirements test: We will then assess the amount of energy your body requires when in a rested state. You will be asked to lie-down relaxed on a comfortable bed for up to 30 minutes where a ventilated hood system will be placed over your head. This will measure the amount of oxygen you consume, and carbon dioxide you breathe out, from which we can calculate your metabolism at rest.
Strength and endurance tests: We will then assess your endurance capacity by asking you to walk 400 metres in total. We will also assess muscular strength using a handgrip dynamometer, and leg strength using specialist equipment called Cybex.
Questionnaires: We will then ask you to complete a series of questionnaires related to your eating behaviour and lifestyle.
Samples: A faecal sample will be collected during this visit. You will be provided with an appropriate container for collection. You will have the option to collect the faecal sample at home prior to your visit or at the test centre.
Physical activity monitor: At the end of the visit you will be given a device to measure your sedentary behaviour and physical activity over the following week, this will be worn on the chest and leg. You are asked to wear this while going about your normal daily activities.
Food and activity diary: You will also be provided with a diary to record your food and drink intake and your physical activity over 3-days. Instruction will be given on how to complete both.
We will also answer any questions you may have about the study and provide you with a light snack.
Baseline appetite testing (Visit 3 - ~4 hours)
A week after visit 2 you will be asked to attend the Institute of Food and Health at UCD in the morning following an overnight fast (without eating or drinking anything other than water since the night before). A fasting blood sample will be collected. You will then be provided with a breakfast meal. Over the course of the following three hours, you will remain at rest appetite ratings and blood samples will be collected periodically. Then a lunch meal will be provided to you. Following the lunch meal another appetite rating will be taken. You will then be given instruction as to what will happen over the subsequent 12-weeks prior to your next visit.
12-week intervention:
Depending on which group you are randomly allocated to, over the next 12 weeks you will be asked to do the following:
Follow a personalised nutrition programme (including newly developed products embedded) & participate in a structured physical activity programme (see details below).
Continue to eat your usual diet while participating in a structured physical activity programme (see details below).
Follow a personalised nutrition programme (including newly developed products embedded) and continue your usual physical activity
Continue to eat your usual diet and your usual physical activity
Personalised Nutrition Programme
If you are assigned to a group involving a personalised nutrition intervention, you will be provided with plant protein & fibre supplements to consume twice daily alongside your normal meals. You will be given advice on how to take these, including recipes and meet with the study nutritionist/dietitian who will also provide you with advice on how to improve your diet. Periodically throughout the intervention, we will call you to go through a dietary recall to ask you about what you have eaten the previous day.
Physical activity Programme
If you are assigned to a group involving physical activity, this will involve structured exercise program based on the successful and safe LIFE trial, incorporating aerobic, strength, flexibility, and balance training. This will consist of attending two group sessions per week at UCD or a nearby community centre. You will also be given advice on training at home and asked to complete three sessions in your own per week.
Post-intervention appetite testing (Visit 4)
The post-intervention appetite test day will be conducted in an identical manner as the appetite test day prior to commencing the intervention. In the week prior you will be asked to wear a device to measure your sedentary behaviour and physical activity again and complete a diary to record your food and drink intake over 3-days.This will be completed in the same manner as prior to the intervention.
Follow-up measurements (Visit 5)
All measurements that were recorded at the start of the study (Visit 2) will be retested.
How will your privacy be protected?
If you participate in the study, your identity will remain confidential, and you will be assigned a unique study ID number. Your name will not be published or disclosed to anyone. All information which is collected about you during the course of the research will be kept strictly confidential. Any information about you such as your name and address will be removed once the data has been entered so that you cannot be recognised from it. This research will be carried out in compliance with the relevant GDPR regulations.
What are the benefits of taking part in this research study?
Your collaboration will help us to better understand the connection between your diet, plant protein and fibre intake, physical activity, and undernutrition with ageing. The results of this study could help us identify strategies to enhance appetite, dietary intake, and health in older adults. This would help to promote healthy and independent ageing. Additionally, you may benefit from supplementation with the nutritional ingredients we are studying, and if you are allocated to the physical activity program, you may improve your fitness and health status.
Will I be paid for taking part in this study?
No.
Will my expenses be covered for taking part in this study?
Yes. You will be reimbursed for any travel cost such as UCD parking.
What are the risks of taking part in this research study?
There exists only minimal risk in the present study. When a blood sample is drawn, there may be a small amount of discomfort when the needle punctures the skin and potential for a small amount of bruising to occur. To ensure this risk is kept to a minimum, you may be assured that samples will be taken with sterile techniques and performed by a trained and experienced phlebotomist. The participants will contact researcher Brian Mullen should any persisting discomfort arise following the visit to UCD. Please contact us using the email address or phone numbers given underneath. Upon contact, we will offer you advice. The researchers involved in this study are indemnified by University College Dublin, and medical insurance is in place. This research necessitates face-to-face meeting and interaction. As such, there is minimal risk of exposure to covid-19. The risk of covid-19 infection will be minimised through the use of appropriate personal protective equipment and hygiene standards. Furthermore, both participant and researcher will be assessed for any covid-19 related symptoms the day prior to their appointment.
Can you change your mind at any stage and withdraw from the study?
If at any time during the study you are uncomfortable with any of the testing or protocols, or if you can no longer commit to the study for whatever reason, you have the option to withdraw from the study up until the date of the final data collection.
How will you find out what happens with this project?
If you wish to find out the results of the project, please let us know and we will inform you of the results when the project is finished.
Who is organising and funding this research?
This study is organised by University College Dublin (UCD). The funding comes from the Health Research Board (HRB) Ireland, under the EU Healthy Diet for a Healthy Life (HDHL) Joint Programming Initiative (JPI) granted to UCD.
Has this study been reviewed by an ethics committee?
Yes. This study has been reviewed and accepted by the UCD Human Research Ethics Committee
Contact details for further information
If you would like any more information on this study, please feel free to contact a member of our dedicated APPETITE team at appetite@ucd.ie OR by phone on 087 2166496 or 01 716 3256.