Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/06/2020
Date assigned
10/06/2020
Last edited
10/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 2023

Who is funding the study?
University College Dublin (Ireland)

Who is the main contact?
Professor Lorraine Brennan
lorraine.brennan@ucd.ie

Trial website

Contact information

Type

Public

Primary contact

Prof Lorraine Brennan

ORCID ID

http://orcid.org/0000-0002-7711-7499

Contact details

University College Dublin
Belfield
Dublin
Dublin 4
Ireland
+35317166815
lorraine.brennan@ucd.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Impact of personalised nutrition advice on diet quality compared to general population advice in healthy volunteers: a randomised controlled trial

Acronym

Study hypothesis

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

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

Study design

Single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measure

Diet quality assessed by the Alternate Mediterranean Diet Score at baseline and 12 weeks

Secondary outcome measures

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.
2. Change in metabolite levels assessed from blood and urine samples taken at baseline and 12 weeks using untargeted metabolomic analysis.

Overall trial start date

20/11/2019

Overall trial end date

01/10/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged between 18 and 65 years
2. BMI ≥18.5 Kg/m2

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

98

Participant exclusion criteria

1. Pregnant or lactating
2. Diagnosed with metabolic disease which interferes with nutritional requirements

Recruitment start date

15/06/2020

Recruitment end date

01/08/2020

Locations

Countries of recruitment

Ireland

Trial participating centre

University College Dublin
Belfield
Dublin
D4
Ireland

Sponsor information

Organisation

University College Dublin

Sponsor details

Belfield
Dublin
Dublin 4
Ireland
+353 1 7166700
RFO@ucd.ie

Sponsor type

University/education

Website

http://www.ucd.ie/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
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.

Intention to publish date

01/10/2023

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/06/2020: Trial’s existence confirmed by University College Dublin Office of Research Ethics.