Impact of personalised nutrition advice on diet quality
| ISRCTN | ISRCTN15305840 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15305840 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University College Dublin |
| Funder | Investigator initiated and funded |
- Submission date
- 08/06/2020
- Registration date
- 10/06/2020
- Last edited
- 05/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims:
Personalised nutrition is commonly described as dietary advice tailored to an individual. Recent studies successfully demonstrated that personalised dietary advice is more effective in producing appropriate changes in dietary intake and health outcomes compared to general population level advice. However, the focus on individuals is still not easily achievable in a public health perspective and may have limited impact on populations.
To take into account the individual biological characteristics in personalised healthcare, metabotypes have been suggested as a potential tool. Metabotypes are groups of individuals defined based on their similarities in the metabolic profile. Metabotypes have been successfully associated with diet-related diseases and differential responses to interventions, which support their use as a means to deliver personalised dietary advice at a group level.
The investigators previous work developed a framework to deliver personalised nutrition advice based on metabotypes. They compared the advice delivered by the metabotype approach to the advice delivered by a dietician and demonstrated that there was a good agreement. This study aims to examine the effectiveness of such an approach to induce behaviour changes and in this instance changes in dietary quality.
Who can participate?
Healthy adults aged between 18 and 65 years old.
What does the study involve?
Participants will be randomly allocated to receive either dietary advice or personalised dietary advice. Measurements include the following: weight, height, waist circumference, hip circumference, blood pressure, blood sample levels of fats and sugars, urine sample, and a 4-day food diary. Participants will follow this dietary guidance for 12 weeks and then measurements will be repeated to see if there have been any improvements.
What are the possible benefits and risks of participating?
Risk: A small percentage of individuals feel faint or faint after giving blood. We will ask all participants to rest for a few minutes following the blood collection. Trained phlebotomists or health care individuals will take blood samples.
Benefits: There will be no direct benefit to the participants from taking part in the study. However, all participants will get to learn about their dietary intake.
Where is the study run from?
University College Dublin (Ireland)
When is the study starting?
From June 2020 to June 2021
Who is funding the study?
University College Dublin (Ireland)
Who is the main contact?
Professor Lorraine Brennan
lorraine.brennan@ucd.ie
Contact information
Public
University College Dublin
Belfield
Dublin
Dublin 4
Ireland
 ORCID ID |
0000-0002-7711-7499 |
|---|---|
| Phone | +35317166815 |
| lorraine.brennan@ucd.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Impact of personalised nutrition advice on diet quality compared to general population advice in healthy volunteers: a randomised controlled trial |
| Study objectives | Personalised dietary advice delivered using a biomarker-driven approach is more effective in changing diet quality than general dietary advice delivered at a population level. |
| Ethics approval(s) | Approved 20/12/2019, UCD Human Research Ethics Committee (Roebuck Castle, University College Dublin, Belfield, Dublin 4, Ireland; +353 1 716 8767; hrec@ucd.ie), ref: LS-19-98-Brennan |
| Health condition(s) or problem(s) studied | Improving quality of dietary intake |
| Intervention | Participants will be randomised (please give ratio of randomisation and method use to randomise) to one of two groups: 1. Intervention group receiving personalised dietary advice using a biomarker-driven approach 2. Control group receiving general dietary advice based on the Healthy Ireland food pyramid Participants will be followed over a period of 12 weeks. Following a baseline assessment (anthropometry, blood pressure, blood and urine samples, diet intake), participants will receive a report indicating key foods and guidance to follow to improve dietary quality. This will be delivered via email. Measurements will be repeated following 12 weeks and change in diet quality assessed. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Diet quality assessed by the Alternate Mediterranean Diet Score at baseline and 12 weeks |
| Key secondary outcome measure(s) |
1. Change in blood biochemistry assessed from lipid parameters and glycaemic parameters (For ex: glucose, Cholesterol, HDL, Triacylglycerol) of blood samples taken at baseline and 12 weeks. |
| Completion date | 28/06/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 98 |
| Total final enrolment | 107 |
| Key inclusion criteria | 1. Aged between 18 and 65 years 2. BMI ≥18.5 Kg/m2 |
| Key exclusion criteria | 1. Pregnant or lactating 2. Diagnosed with metabolic disease which interferes with nutritional requirements |
| Date of first enrolment | 15/06/2020 |
| Date of final enrolment | 01/08/2020 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
D4
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as consent from participants does not include this. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | secondary analysis | 15/11/2023 | 05/12/2023 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/12/2023: Publication reference added.
11/07/2022: The overall trial end date has been changed from 01/10/2023 to 28/06/2021 and the plain English summary has been updated accordingly.
07/07/2022: The total final enrolment number has been added.
09/06/2020: Trial’s existence confirmed by University College Dublin Office of Research Ethics.
