- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06879574
Identifying the Best Tools for Recording Diet in Free-living UK Adults (SODIAT-2 Study) (SODIAT-2)
Investigating a Data-driven Standardized and Objective Dietary Intake Assessment Tool in Free-living Individuals - SODIAT-2 Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The SODIAT project is a collaborative effort involving Aberystwyth University (AberU, project lead), University of Reading (UoR), Imperial College London (Imperial), and the University of Cambridge (UoC). Study 1, completed in July 2024, assessed the effectiveness of objective and subjective dietary intake assessment methods in highly-controlled clinical trial (protocol published at https://doi.org/10.12688/f1000research.155683.1) and informed the design of study 2.
Study 2 is led and sponsored by UoR. All study activities will be conducted remotely, with participants taking part from their usual locations (e.g., home, work).
►Screening and Welcome Week
Participants will use the online REDCap research platform to provide informed consent and complete a screening questionnaire to determine eligibility. Eligible participants will be contacted by a study researcher to discuss the study requirements, confirm consent, and schedule the study period.
A week before starting the 5-week study (Welcome Week), participants will be sent study materials/equipment and will be referred to the SODIAT webpage to view online video tutorials and read user guidelines for each study tool. Afterwards, participants will attend a video call with a study researcher to familiarize them with the study protocol and provide an opportunity to ask questions.
During the Welcome Week, participants will also self-collect a baseline blood sample (pre-video call) and complete the online eNutri FFQ to assess habitual diet. Within 2 days, they will then complete a condensed version of the FFQ to evaluate its effectiveness in estimating diet quality with reduced participant burden.
►5-week study period
Participants will follow their usual diet during weeks 1 & 5 and record their diet using study tools (wearable cameras, blood samples, urine samples and online FFQ) for 3 consecutive days (Monitoring Weeks). During week 3 (Calibration Week), participants will use the same study tools as before whilst consuming the 3-day test diet. There will be two test diets (one diet for meat/fish consumers and another slightly adapted for non-consumers), consisting of foods and drinks that are common in the UK. During this controlled part of the study, participants will be requested to eat/drink all foods and drinks provided (delivered by an online supermarket) but cannot consume anything extra. They will receive recommendations on serving sizes for each food/drink but participants can choose how much they eat (either more or less).
►Wearable cameras
Participants will wear a small camera unit mounted on glasses (or attached to their own frames) during the 3-day periods of weeks 1, 3, and 5 (days 1-3; 15-17 and 32-34). The camera automatically captures still images every 7 seconds to document food and drink intake. The camera will be worn from waking to going to bed, although participants will be instructed to remove the camera during private times (e.g., bathroom), sensitive locations (e.g., changing rooms, GP surgeries) and if unsafe to wear (e.g., driving), and log these occasions, as well as the camera start time, on a paper-based log. At the end of the study, encrypted SD cards containing the images will be returned to the research team at Imperial for secure processing.
Images will be pre-processed using AI to exclude irrelevant images, and blur identifying details (e.g., faces, device screens). Only anonymised images will be analysed by researchers to estimate dietary intake.
►Capillary blood samples
When fasted, participants will self-collect blood samples using OneDraw kits on day 4 of each study week (day 4, 18 and 35), which collect a few drops of blood from the upper arm/thigh onto a filter paper cartridge. A baseline sample will also be collected during the Welcome Week. Instructions and video tutorials will be provided, and samples will be mailed to researchers at UoC for storage and biomarker analysis.
►Spot urine samples
Over 4 consecutive days of each study week (days 1-4, 15-18, 32-35), participants will collect first morning void and last evening void urine samples using straw and vacuum tube kits. Samples will be temporarily stored in a refrigerator before mailing them to AberU for processing where biomarkers of food and drink intake will be analysed.
►Online FFQ (eNutri)
Participants will complete the online eNutri FFQ on six occasions. Both the original (long-format) and condensed FFQ will be completed during Welcome Week to capture habitual intake during the previous 4 weeks. During the study, a 3-day, condensed FFQ adapted to capture foods/drinks not well-represented by biomarker analysis, will be completed at the end of each recording week (day 4, 18 and 35). During the test diet week, the original FFQ, adapted to capture 3-day intakes, will also be completed (day 18). The FFQ inputs, nutrient and food group intakes, and diet quality data will be exported in pseudonymised format for analysis.
At the study's conclusion, participants will complete a short, online usability questionnaire about the study tools via REDCap (day 35).
Participants will mail their blood and urine samples at designated timepoints using pre-paid postage, and return all study equipment and logs at the end of the study via a courier collection.
Researchers will monitor adherence and communicate with participants as needed. Daily reminders will also be sent via email or text (SMS) message during the recording days.
► Statistical analysis
Accuracy of integrating multiple dietary assessment technologies to report dietary intake in free living environments will be measured during the calibration week (week 3) using dietary intake data collected from wearable cameras, spot urine samples, capillary blood samples, and self-reported FFQs.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Julie A Lovegrove, Professor
- Phone Number: +44 (0) 118 378 6418
- Email: j.a.lovegrove@reading.ac.uk
Study Contact Backup
- Name: Michelle Weech, Dr
- Email: m.weech@reading.ac.uk
Study Locations
-
-
-
Aberystwyth, United Kingdom, SY23 3DA
- Recruiting
- Department of Life Sciences, Aberystwyth University
-
Contact:
- Manfred Beckmann, Dr
- Phone Number: +44 1970622340
- Email: meb@aber.ac.uk
-
Contact:
- Amanda Lloyd, Dr
- Phone Number: +44 1970 622789
- Email: abl@aber.ac.uk
-
Principal Investigator:
- Manfred Beckmann, Dr
-
Sub-Investigator:
- John Draper, Professor
-
Sub-Investigator:
- Thomas Wilson, Dr
-
Sub-Investigator:
- Amanda Lloyd, Dr
-
Cambridge, United Kingdom, CB2 0QQ
- Not yet recruiting
- University of Cambridge, Pathology building level 4, Addenbrooke's Hospital
-
Contact:
- Albert Koulman, Dr
- Phone Number: +44 223 763202
- Email: ak675@cam.ac.uk
-
Principal Investigator:
- Albert Koulman, Dr
-
London, United Kingdom, W12 0NN
- Not yet recruiting
- Nutrition Research Section, Hammersmith Hospital Campus, Imperial College
-
Contact:
- Gary Frost, Professor
- Phone Number: +44 20 7594 0959
- Email: g.frost@imperial.ac.uk
-
Principal Investigator:
- Gary Frost, Professor
-
Sub-Investigator:
- Stamatia Giannarou, Dr
-
Sub-Investigator:
- Frank P.-W. Lo, Dr
-
Sub-Investigator:
- Adrian R Solis, Dr
-
Sub-Investigator:
- George Mylonas, Dr
-
-
Berkshire
-
Reading, Berkshire, United Kingdom, RG6 6DZ
- Recruiting
- Hugh Sinclair Unit of Human Nutrition, University of Reading
-
Principal Investigator:
- Julie A Lovegrove, Professor
-
Contact:
- Michelle Weech, Dr
- Email: m.weech@reading.ac.uk
-
Contact:
- Julie A Lovegrove
- Phone Number: +44 118 378 6418
- Email: j.a.lovegrove@reading.ac.uk
-
Sub-Investigator:
- Michelle Weech, Dr
-
Sub-Investigator:
- Rosalind Fallaize, Dr
-
Sub-Investigator:
- Eka Bobokhidze
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years and older
- Lives in Great Britain (England, Schotland and Walse)
- Able to read/understand instructions written in English and are fluent in English
Exclusion Criteria:
- 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.)
If the participants have recently taken part in another intervention study, a 4-week washout will be required before they are able to start the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary intake measured by wearable camera technology.
Time Frame: Days 1- 3 (week 1), days 15-17 (week 3) and days 32-34 (week 5).
|
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.
Time Frame: Morning and evening spot urine samples collected over 4 consecutive days on weeks 1, 3 and 5 (days 1-4, 15-18, 32-35).
|
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.
Time Frame: Samples collected at fasted state in the morning of days 4, 18 and 35 (weeks 1, 3 and 5).
|
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).
Time Frame: Days 4, 18 and 35 (weeks 1, 3 & 5).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Habitual dietary intake (original eNutri FFQ).
Time Frame: Baseline.
|
Habitual intake will be measured by the original 4-week eNutri FFQ.
Outcomes include dietary intakes (frequency, portion size and grams per day) for each FFQ item, nutrient intakes, food group intakes and diet quality score.
|
Baseline.
|
|
Habitual dietary intake (condensed original FFQ).
Time Frame: Baseline, after original eNutri FFQ.
|
Habitual intake will be measured by the condensed 4-week eNutri.
Outcomes include dietary intakes (frequency, portion size and grams per day) for each FFQ item, nutrient intakes, food group intakes and diet quality score.
|
Baseline, after original eNutri FFQ.
|
|
Calibration week dietary intake (3-day eNutri FFQ).
Time Frame: Day 18, week 3.
|
Food/drink intake during the 3-day calibration week ( week 3) will be measured by the 3-day FFQ.
Outcomes include dietary intakes (frequency, portion size and grams per day) for each FFQ item, nutrient intakes, food group intakes and diet quality score.
|
Day 18, week 3.
|
|
Usability questionnaire for each research tool.
Time Frame: Day 35, week 5.
|
Short qualitative feedback questionnaire will be administered online via REDCap to determine participants' perspectives on usability of each study tool (including Likert scale questions "strongly disagree to strongly agree" and free text responses).
|
Day 35, week 5.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UREC 24/43
- (MR/W028336/1) (Other Grant/Funding Number: Medical Research Council (MRC) and the Biotechnology and Biological Sciences Research Council (BBSRC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dietary Intake Assessment
-
Pennington Biomedical Research CenterCompletedFood Intake | Energy Intake | Dietary Assessment | Food PhotographyUnited States
-
Imperial College LondonRecruitingHealthy Volunteers | Blood Glucose | Wearables | Metabolism | Energy Intake | Digestion | Dietary Intake AssessmentUnited Kingdom
-
Imperial College LondonBoston University; University of Colorado, Denver; Baylor College of Medicine; University... and other collaboratorsRecruitingMalnutrition | Dietary Intake Assessment | Passive Dietary MonitoringUnited Kingdom
-
Far Eastern Memorial HospitalFu Jen Catholic UniversityRecruitingPregnancy | Nutrition | Methylation | Birth Outcomes | Homocysteine | Trimethylamine N-oxide (TMAO) | Dietary Intake Assessment | Dietary Quality | Infant NeurodevelopmentTaiwan
-
University of Kansas Medical CenterActive, not recruitingMRI | Cognition | Physical Function | Dietary Intake Assessment | Pre-frail | Pre-Frail Older AdultsUnited States
-
Penn State UniversityAlliance for Potato Research and EducationEnrolling by invitation
-
Uniformed Services University of the Health SciencesUniversity of Maryland, Baltimore; Pennington Biomedical Research Center; Henry... and other collaboratorsCompletedDietary IntakeUnited States
-
Tufts UniversityMassachusetts Institute of TechnologyCompleted
-
Purdue UniversityCompletedLow Protein Dietary Intake | High Protein Dietary IntakeUnited States
-
Peking University First HospitalNot yet recruitingDietary Sodium Intake
Clinical Trials on Measuring dietary intake
-
University of California, San DiegoCompleted
-
University of California, San FranciscoAga Khan University; Makerere University; Kathmandu University School of Medical... and other collaboratorsCompletedWasting | Stunting | Feeding Patterns | Feeding; Difficult, Newborn | Undernutrition | Feeding, BreastUganda, United States, Guinea-Bissau, Nepal, Pakistan
-
Harvard School of Public Health (HSPH)National Cancer Institute (NCI); National Institutes of Health (NIH); National...CompletedCardiovascular Diseases | Cerebrovascular Disorders | Neoplasms | Diabetes Mellitus | Endocrine System Diseases | Pregnancy Complications | Neurologic Symptoms | Metabolic Disease | Skeletal Anomalies
-
University of CopenhagenMaastricht University Medical CenterActive, not recruitingDiet, Healthy | Protein DeficiencyDenmark
-
Medical Research CouncilCompletedAberrant DNA Methylation
-
University of Texas Southwestern Medical CenterRecruitingChronic Kidney Disease Mineral and Bone Disorder | Chronic Kidney Disease (Stage 3-4)United States
-
DLR German Aerospace CenterCharite University, Berlin, Germany; University of Erlangen-Nürnberg; University...CompletedEnergy Metabolism | Bone Metabolism | Electrolyte Metabolism | Acid-Base Metabolism | Circulation SystemGermany
-
United States Army Research Institute of Environmental...USDA Grand Forks Human Nutrition Research Center; Eastern Michigan UniversityCompletedWeight Loss | Bone Loss | Muscle LossUnited States
-
King Saud Bin Abdulaziz University for Health SciencesCompleted
-
University of CopenhagenDairy Farmers of Canada; The Danish Dairy Research Foundation, Denmark; Dairy... and other collaboratorsCompleted