Identifying the Best Tools for Recording Diet in Free-living UK Adults (SODIAT-2 Study)

NCT06879574 | Recruiting DMC

• 2 other identifiers: UREC 24/43(MR/W028336/1)
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of the SODIAT-2 study is to evaluate the effectiveness of dietary intake assessment tools in a real-world setting. These tools include wearable cameras, spot urine samples, capillary blood samples, and a web-based food frequency questionnaire (FFQ). The main questions it aims to answer are: Is the accuracy of dietary assessment improved in free-living environments when a combination of subjective and objective assessments tools are used? Secondary research questions are: Can wearable cameras accurately monitor the daily dietary intake of free-living individuals? Does a combination of capillary blood samples and spot urine samples provide a robust assessment of the nutrient status and habitual dietary exposure in a free-living setting? Can data-driven integration of multiple emerging technologies create a dietary assessment tool that is low burden, accurate and scalable in free-living populations? Can a condensed FFQ estimate diet quality as effectively as a detailed FFQ? Participants will: Use the dietary assessment tools (wearable camera, spot urine, capillary blood, and eNutri FFQ web-app) as instructed over a 5-week period from their home and/or working space. Take part in two monitoring weeks (week 1 and week 5) where they will record their usual dietary intake over 3 days. Consume an identical 3-day study meal plan during the test (calibration) diet week 3, whilst repeating the monitoring week measurements. This study aims to recruit 133 adults living in Great Britain (GB) to better understand how these tools perform outside of a clinical environment.

Conditions

Dietary Intake Assessment; Food Intake Measurement

Keywords

Nutrition; Health; Dietary reporting; Misreporting

Outcome Measures

Primary Outcomes (4)

• Dietary intake measured by wearable camera technology.

  Wearable cameras will be worn by the participants during the study days. Images from wearable cameras will be analysed to estimate what foods and drinks were consumed during the study days, as well as estimating their portion sizes (grams per day).

  Days 1- 3 (week 1), days 15-17 (week 3) and days 32-34 (week 5).

• Dietary intake measured by spot urine.

  A range of biomarkers indicating what a person has eaten/drank will be measured in urine samples.

  Morning and evening spot urine samples collected over 4 consecutive days on weeks 1, 3 and 5 (days 1-4, 15-18, 32-35).

• Dietary intake measured by blood sample.

  A range of food/drink biomarkers will be measured in capillary blood samples to indicate what a person has eaten/ drank.

  Samples collected at fasted state in the morning of days 4, 18 and 35 (weeks 1, 3 and 5).

• Monitoring/calibration week dietary intake (condensed 3-day FFQ).

  Food/drink intake during the 3-day study periods will be measured by the 3-day condensed FFQ (adapted to capture foods not represented by biomarker analysis). Outcomes include dietary intakes (frequency, portion size and grams per day) for each FFQ item, nutrient intakes, food group intakes and diet quality score.

  Days 4, 18 and 35 (weeks 1, 3 & 5).

Secondary Outcomes (4)

• Habitual dietary intake (original eNutri FFQ).

  Baseline.

• Habitual dietary intake (condensed original FFQ).

  Baseline, after original eNutri FFQ.

• Calibration week dietary intake (3-day eNutri FFQ).

  Day 18, week 3.

• Usability questionnaire for each research tool.

  Day 35, week 5.

Study Arms (1)

Free-living adults living in GB

The study aims to recruit 133 adults living in GB with BMI more than 18.5 kg/m2 who are fluent in English. Participants will monitor their usual dietary intake during two 3-day monitoring periods during weeks 1 and 5 by wearing camera technology, self-collecting blood and urine samples at designated times, and completing online food frequency questionnaire on multiple occasions. During the calibration week (week 3) participants will consume the same 3-day test diet (either the diet for meat/fish consumers or non-consumers, as identified at screening).

Other: Measuring dietary intake

Interventions

Measuring dietary intake OTHER

During 5-week study, participants will monitor their usual dietary intake during two 3-day periods (on weeks 1 and 5). During week 3 (calibration week) participants will consume a test diet. Wearable camera technology, self-collected blood and urine samples, and online FFQ (eNutri) will be used to monitor food intake during study weeks. Study tools as well as foods/drinks for the test diet will be delivered to each participant and they will be asked to comply with the study procedures in their home or working environment. Participants will post study samples and the study equipment/logs at designated times using pre-paid envelopes or a courier collection, respectively.

Free-living adults living in GB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UK population.

You may qualify if:

• years and older
• Lives in Great Britain (England, Schotland and Walse)
• Able to read/understand instructions written in English and are fluent in English

You may not qualify if:

• Diagnosed or self-report as being underweight (have a body mass index (BMI) of less than 18.5 kg/m2)
• Are unwilling/unable to collect urine and blood samples, use the wearable camera as instructed and/or spend 20-30 min online recording what they've recently had to eat/drink on multiple occasions
• Are unwilling/unable to have a video call with a researcher with cameras turned on
• Are unwilling/unable to post samples on specific days and receive/send a larger parcel at the start/end of the study (note: all return packaging and postage will be provided by us and will include a courier delivery and collection)
• Are unwilling/unable to receive a single grocery delivery from Sainsbury's or Tesco online supermarkets (delivery to be arranged by us), includes living in a postcode area that cannot receive grocery deliveries from Tesco or Sainsburys as well as not having space to refrigerate and freeze items.
• Are unwilling/unable to eat/drink any items on the calibration menu, e.g., food allergies/intolerances, dislike of food items, unable eat (e.g. vegan or have to avoid for a medical condition) or cannot eat 3 meals plus snacks daily (note: vegetarians can take part)
• Are unwilling/unable to avoid taking dietary and herbal supplements for at least 1 week before and during the 5-week study (e.g. fish oils, vitamins, iron, protein shakes, nutrient powders, joint care)
• Are pregnant, may be pregnant or breast-feeding
• Currently experiencing, recovering or at a high risk of an eating disorder (e.g., previous diagnosis, or concerns that you have an unhealthy relationship with food)
• Have a health condition, are taking medication and/or undergoing medical treatment that affects metabolism, appetite and/or ability to eat the calibration menu (e.g. cancer, chemotherapy, diabetes, gastrointestinal disorders (such as inflammatory bowel disease, Crohn's disease), kidney disease, liver disease, HIV or AIDS)
• Are taking any of the following medications: androgens, blood thinners, phenytoin, erythromycin, or thyroid hormones
• Long-term use of any of the following medications: anti-inflammatories (NSAIDS), steroids/corticosteroids or antibiotics (eligible following a 4-week washout after short term use; eligible if use is infrequent)
• Use illicit substances/recreational drugs
• Have been diagnosed with dementia or other conditions affecting memory
• Do not have anyone at home, work, etc. to help them if they require assistance to use the study tools (such as arthritis, Parkinson's disease, sight loss, etc.)

Sponsors & Collaborators

• University of Reading: lead
• Aberystwyth University: collaborator
• University of Cambridge: collaborator
• Imperial College London: collaborator

Study Sites (4)

Hugh Sinclair Unit of Human Nutrition, University of Reading

Reading, Berkshire, RG6 6DZ, United Kingdom

RECRUITING

Department of Life Sciences, Aberystwyth University

Aberystwyth, SY23 3DA, United Kingdom

RECRUITING

University of Cambridge, Pathology building level 4, Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

NOT YET RECRUITING

Nutrition Research Section, Hammersmith Hospital Campus, Imperial College

London, W12 0NN, United Kingdom

NOT YET RECRUITING

Related Links

• SODIAT webpage

Biospecimen

Retention: SAMPLES WITH DNA

Urine and blood samples will be retained. Dried capillary blood samples will be retained at the UoC but will not be used to extract DNA. They will be analysed for biomarkers of food/drink intake (e.g. fats and dairy products). Urine samples will be processed and retained in an acellular form (ensuring they are not relevant for DNA extraction) at the AberU. A range of biomarkers of food /drink intake will be measured at the end of study.

Study Officials

• Manfred Beckmann, Dr

  Department of Life Sciences, Aberystwyth University

  PRINCIPAL INVESTIGATOR

• Julie A Lovegrove, Professor

  Hugh Sinclair Unit of Human Nutrition Department of Food and Nutritional Sciences, University of Reading

  PRINCIPAL INVESTIGATOR

• Gary Frost, Professor

  Nutrition Research Section, Hammersmith Hospital Campus, Imperial College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie A Lovegrove, Professor

CONTACT

+44 (0) 118 378 6418; j.a.lovegrove@reading.ac.uk

Michelle Weech, Dr

CONTACT

m.weech@reading.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 17, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: To be made available at the point of publication.
• Access Criteria: The SODIAT Project Lead, Dr Manfred Beckmann (AberU) will have overall authority over the central data repository. The Principal Investigator at UoR, Professor Julie Lovegrove, will have authority over any data collected and stored at UoR, including REDCap and eNutri.

Locations

GB (4)