A dual-site dietary intervention study to integrate dietary assessment methods

Not Applicable

• Conditions: utritional intake; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN13562899
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-01
• Last Update Posted: 16 October 2023
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Aged 18 – 70 years
2. Body Mass Index (BMI) 20-30 kg/m²

Exclusion Criteria

1. Have been involved in any other study during the previous 12 weeks, are not able to commit to the study (e.g., travel commitments) or are unwilling to collect urine and blood samples and wear the micro-camera
2. Had a weight change of more than 3kg in the preceding 3 months or are currently following a weight-loss diet
3. Have excess alcohol intake (more than 21 units per week) (e.g., a medium glass of wine = 2.3 units)
4. Are unwilling to abstain from drinking alcohol and avoiding strenuous exercise during the two 5-day test periods
5. Are unwilling to follow the study menus (e.g., dislike of food items, following a restrictive/specialised diet or receiving specialised dietary advice for a medical condition); participants will not be permitted to eat/drink anything else during the two 5-day test periods
6. Are not able to eat fish and/or meat (e.g., are vegan or vegetarian)
7. Have an allergy/intolerance to any of the food items in the menu
8. Have taken any dietary supplements in the last 3 months (e.g., multivitamins, fish oils)
9. Are pregnant or lactating
10. Currently, suffer from any of the following: eating disorders, diabetes, cancer, gastrointestinal disorders (e.g., inflammatory bowel disease or irritable bowel syndrome), kidney disease, liver disease, pancreatitis, HIV or AIDS or any other chronic illness
11. Are taking any of the following medications: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin, or thyroid hormones
12. Use illicit substances
13. Have been diagnosed with dementia or other conditions affecting memory
14. Have difficulty using laptops/tablets (e.g., cannot use these devices without assistance, are blind or have other conditions affecting sight, or have physical disabilities/conditions that affect your ability to press buttons)
15. Cannot read and understand English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The accuracy of dietary reporting will be measured at the end of each intervention week using dietary data collected from wearable micro cameras, spot urine samples, capillary blood samples, and self-report dietary recalls. Total daily consumption (grams per day) will be reported by wearable micro cameras and self-report dietary recalls. Liquid chromatography-mass spectrometry (LC-MS) will measure biomarkers of dietary components in spot urine samples and capillary blood samples and daily dietary intake will be reported using µg/ml concentrations of dietary exposure biomarkers.

Secondary Outcome Measures

Name	Time	Method
1. Creation of a multiplatform model of dietary intake using g/day measured from wearable micro-cameras and self-report dietary recalls, and µg/ml of dietary exposure biomarkers from spot urine samples and capillary blood samples at the end of the study<br>2. Design a dietary intake study informed by the results of the dietary intake study protocol in a free-living population at the end of the study<br><br>