NCT04761575

Brief Summary

The aim is to determine whether the eNutri web application can effectively estimate the dietary intake of a UK older population. The eNutri FFQ65+ study will validate the eNutri online food frequency questionnaire (FFQ) using 100 adults aged 65+ years. The FFQ will be validated against an online 24-hour dietary recall system (Intake24) and its reproducibility will be evaluated by the completion of two FFQs within a 14-day interval. In addition, all participants will also be asked to provide dried blood spot (DBS) samples which will be analysed for key biomarkers of nutritional intake and health. Biomarker results will be compared to FFQ results to further validate the eNutri FFQ.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

February 12, 2021

Last Update Submit

April 12, 2023

Conditions

Keywords

Food frequency questionnaireNutritionDietary intake

Outcome Measures

Primary Outcomes (1)

  • eNutri dietary intake

    eNutri FFQ1 dietary data

    Baseline

Secondary Outcomes (1)

  • eNutri dietary intake

    Day 14

Other Outcomes (5)

  • 24-hour dietary recall intake

    Baseline

  • Dried blood spot biomarkers

    Baseline

  • Height

    Baseline

  • +2 more other outcomes

Study Arms (1)

FFQ validation

All participants to complete all aspects of the study.

Other: Validation of the FFQ65+ via eNutri app

Interventions

All participants will provide two eNutri FFQ datasets within a 14-day interval along with three 24-hour dietary recalls and dried blood spot samples.

FFQ validation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 65 and over who live in the UK

You may qualify if:

  • Aged 65 years or over
  • Live in the UK
  • Able to spend approximately 30 minutes using a screen on a device
  • Do not have a diagnosis of dementia or another condition affecting memory
  • Do not have a food allergy or food intolerance (self- or medically diagnosed)
  • Are not following a weight loss diet
  • Generally eat on 2 or more occasions everyday

You may not qualify if:

  • Follow a specialised or restricted diet (not including vegan and vegetarian diets)
  • Have a medical condition or take medications that do not allow an individual to eat a stable diet on a day-to-day basis (e.g. severe gastrointestinal condition)
  • Anticipate changes to their diet within the next three weeks (e.g. surgery, holiday, receiving nutritional advice from a professional)
  • Have participated in another nutrition study that included a specific dietary regime in the last 4 weeks or are currently participating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6DZ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots will be collected from participants but will not be used to extract DNA. The dried blood spots will be used to validate the FFQ against selected biomarkers such as markers of health (e.g. cholesterol) and markers of nutrient intake (e.g. carotenoids).

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Julie Lovegrove, Professor

    Hugh Sinclair Unit of Human Nutrition, University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Hugh Sinclair Unit of Human Nutrition

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 21, 2021

Study Start

April 21, 2021

Primary Completion

November 22, 2021

Study Completion

November 22, 2021

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

The researchers are part of the FNS-Cloud Consortium. Anonymised FFQ, 24h recall and DBS data will be on shared on FNS-Cloud (in development; https://www.fns-cloud.eu/) at the end of the project.

Time Frame
Data available at the end of the project.
Access Criteria
Will depend on FNS-Cloud access criteria (https://www.fns-cloud.eu/) - to be decided by the consortium.

Locations