Impact of personalised nutrition advice on diet quality

ISRCTN ISRCTN15305840
DOI https://doi.org/10.1186/ISRCTN15305840
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

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

Prof Lorraine Brennan
Public

University College Dublin
Belfield
Dublin
Dublin 4
Ireland

ORCiD logoORCID ID 0000-0002-7711-7499
Phone +35317166815
Email lorraine.brennan@ucd.ie

Study information

Study designSingle-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleImpact of personalised nutrition advice on diet quality compared to general population advice in healthy volunteers: a randomised controlled trial
Study hypothesisPersonalised 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
ConditionImproving quality of dietary intake
InterventionParticipants 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 typeBehavioural
Primary outcome measureDiet quality assessed by the Alternate Mediterranean Diet Score at baseline and 12 weeks
Secondary outcome measures1. 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.
2. Change in metabolite levels assessed from blood and urine samples taken at baseline and 12 weeks using untargeted metabolomic analysis.
Overall study start date20/11/2019
Overall study end date28/06/2021

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants98
Total final enrolment107
Participant inclusion criteria1. Aged between 18 and 65 years
2. BMI ≥18.5 Kg/m2
Participant exclusion criteria1. Pregnant or lactating
2. Diagnosed with metabolic disease which interferes with nutritional requirements
Recruitment start date15/06/2020
Recruitment end date01/08/2020

Locations

Countries of recruitment

  • Ireland

Study participating centre

University College Dublin
Belfield
Dublin
D4
Ireland

Sponsor information

University College Dublin
University/education

Belfield
Dublin
Dublin 4
Ireland

Phone +353 1 7166700
Email RFO@ucd.ie
Website http://www.ucd.ie/
ROR logo "ROR" https://ror.org/05m7pjf47

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/10/2023
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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

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.