Protein intake and health outcomes
| ISRCTN | ISRCTN16651067 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16651067 |
- Submission date
- 22/09/2021
- Registration date
- 01/10/2021
- Last edited
- 18/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Emerging evidence suggests that increased protein intake is associated with several health outcomes. Higher total protein intake is proposed to help preserve lean body mass and improve body composition during weight loss in adults. Other literature suggests high protein diets may help improving blood lipids, markers of glycaemic control, and blood pressure. Further, some studies observed a better sleep quality among persons with high compared to low protein intake. However, thus far evidence is either limited to a few studies examining this research question or inconclusive about the role of the type and timing of protein intake.
The aim of the project is to investigate the ability of increased protein intake to alter health outcomes including muscle function, sleep quality, metabolic health, and quality of life.
Who can participate?
Male and female healthy adults aged 50 years or older.
What does the study involve?
Participants will be randomly allocated to one of the following:
1) an intervention group receiving a high protein ready-to-mix drink (~20g of milk protein isolate),
2) an intervention group receiving a high protein ready-to-mix drink (~20g of plant protein mix),
3) a control group receiving a ready-to-mix drink based on carbohydrates (maltodextrin).
Samples and measurements will be taken before the intervention and at 12 weeks.
What are the possible benefits and risks of participating?
Higher total protein intake is proposed to help preserve lean body mass and improve body composition in older adults. Other literature suggests high protein diets may help improve blood lipids, markers of glycaemic control, blood pressure, as well as sleep quality. In older adults, general health, including the mentioned markers, is more and more limited. Protein intake is often insufficient. The high-protein drink will offer an easy way to increase the amount of protein in this age group.
Where is the study run from?
University College Dublin, Conway Institute (Ireland)
When is the study starting and how long is it expected to run for?
September 2021 to January 2023
Who is funding the study?
We received funding from multiple sources including the H2020 European Research Council and the Marie Skłodowska-Curie Career Development Fellowship in the National Technology Centre Programme funded through a co-fund with the European Union’s Horizon 2020 and Enterprise Ireland. All test products were provided by Kerry Group, Ireland.
Who is the main contact?
Dr. Janine Wirth, janine.wirth@ucd.ie
Contact information
Scientific
UCD Institute of Food and Health
Belfield
Dublin
4
Ireland
 ORCID ID |
0000-0001-7075-9686 |
|---|---|
| Phone | +353 (0)1 716 6811 |
| janine.wirth@ucd.ie |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Impact of protein intake on health outcomes |
| Study objectives | The aim of the project is to investigate the ability of increased protein intake to alter health outcomes including muscle function, metabolic health, sleep quality, and quality of life (QoL). We hypothesise a positive effect of increased protein intake on these health outcome that might depend on the type of protein consumed. |
| Ethics approval(s) | Approved 23/09/2021, UCD Human Research Ethics Committee (Roebuck Castle, University College Dublin Belfield, Dublin 4, Ireland; +353 1 716 8767; hrec@ucd.ie), ref: LS-21-67-Wirth-Brennan |
| Health condition(s) or problem(s) studied | Improve muscle function (and body composition, metabolic health, sleep quality, and overall quality of life) in older adults |
| Intervention | This is a double-blinded randomised controlled intervention study with older adults designed to measure the impact of increased protein intake and markers of general health, including muscle function, metabolic health, sleep quality, and QoL. Participants will be randomly allocated (using an online tool) to one of the following: 1) an intervention group receiving a high dairy-based protein ready-to-mix (RTM) drink (~20g of milk protein isolate), 2) an intervention group receiving a high plant-based protein RTM drink (~20g of pea/rice protein mix), 3) a control group receiving a RTM drink based on carbohydrates (maltodextrin). Prior to the intervention, the participants will have the following measured: dietary intake, sleep quality (Pittsburgh sleep quality index = PSQI), and quality of life (SF-36 questionnaire). All will be posted or emailed and filled out by participants. In addition, blood pressure will be measured, a blood sample will be taken, handgrip and leg press strength tests will be performed, as well as a timed up and go test. Furthermore, anthropometry (weight, height, waist circumference, hip circumference, and body composition using BODPOD) will be measured. At week 12, participants will return for the final visit when all the measurements will be repeated in the same way as before. |
| Intervention type | Supplement |
| Primary outcome measure | Muscle strength (hand grip, leg press) at baseline and 12 weeks |
| Secondary outcome measures | Measured at baseline and 12 weeks: 1. Functional mobility (timed up and go test) 2. Body composition (fat mass, fat-free mass) measured using BodPod. 3. Biomarkers: cholesterol, glucose, triglycerides 4. Sleep quality (Pittsburgh Sleep Quality Index) 5. Quality of life (SF-36 questionnaire) |
| Overall study start date | 23/09/2021 |
| Completion date | 27/01/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 171 participants, allowing for drop-outs (57 for each group). The sample size was ascertained using GPower software based on the association between protein intake and handgrip strength. Assuming a small effect size of 0.12, a power of 0.8 and an alpha of 0.05, 141 participants are necessary to include into the nutrition intervention study. We added 20% (10 participants per group) to allow drop-outs. Handgrip strength is a commonly used measure of muscle function in populations of older adults. |
| Key inclusion criteria | Healthy male and female adults aged 50 years and older |
| Key exclusion criteria | 1. A diagnosed chronic/metabolic disease which alters nutritional needs (e.g. thyroid disorders, diabetes, inflammatory bowel diseases). 2. Food allergy/intolerance against peas, milk products 3. Athletes/bodybuilders meeting all the following: 4. Training in sports to improve his/her performance 5. actively competing in sports competitions 6. formally registered in a local/national/regional sport 7. To have sport training or competition as his/her major activity or focus of personal interest; devoting several hours in all or most of the days for these activities, exceeding the time allocated to other types of professional or leisure activities. 8. Pregnant, lactating 9. Anyone unable to give consent or converse fluently in English |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 31/10/2022 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Belfield
Dublin
4
Ireland
Sponsor information
University/education
UCD Institute of Food and Health
Belfield
Dublin
4
Ireland
| Phone | +353 (0)833991008 |
|---|---|
| lorraine.brennan@ucd.ie | |
| Website | http://www.ucd.ie/ |
"ROR" |
https://ror.org/05m7pjf47 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme, European Union Framework Programme for Research and Innovation
Results and Publications
| Intention to publish date | 28/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We plan to publish the results in a peer-reviewed nutritional journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/05/2024 | 18/11/2024 | Yes | No |
Editorial Notes
18/11/2024: Publication reference added.
28/04/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2022 to 31/10/2022.
2. The overall trial end date was changed from 30/08/2022 to 27/01/2023.
3. The intention to publish date was changed from 28/02/2023 to 28/09/2023.
27/01/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2021 to 31/05/2022.
2. The overall trial end date has been changed from 31/05/2022 to 30/08/2022 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 31/10/2022 to 28/02/2023.
28/09/2021: Trial's existence confirmed by University College London.
