Validity and Reproducibility of Dietary Assessment Against Objective Measures

Completed

• Conditions: Validation Study

• Registration Number: NCT05600530
• Lead Sponsor: Inge Tetens

Brief Summary

A cross-sectional study with repeated measurements among healthy Danish adults to assess the validity and reproducibility of a self-administered 7-day web-based dietary assessment tool, myfood24® tested against objective biomarkers.

Detailed Description

Healthy volunteers (age 35-70 yrs; BMI 22-32) will be recruited for the study. Informed consent will be obtained and participants will complete a self-administered web-based 7-day 24-hour dietary recall tool (myfood24®).Validity of this dietary registration tool will be assessed by comparing the estimated intake of selected nutrients (protein, energy) and selected food groups (fruit and vegetables, whole grain, coffee, alcoholic beverages) against objective biomarkers obtained from a 24-hour urine sample, through a measurement of resting energy metabolic rate, and from a fasting blood sample, respectively. Reproducibility will be assessed by comparison of the results from two self-administered web-based 7-day 24-hour dietary recalls obtained 4 weeks (± 1 weeks) apart.

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-26
• Study Start: 2022-10-31
• Study First Posted: 2022-10-31
• Primary Completion: 2023-08-25
• Study Completion: 2023-08-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

• Clinically diagnosed chronic disease,
• use of corticosteroids or other medication that would potentially affect the nutrient metabolism or excretion of biomarkers of interest,
• presence of food allergy or intolerance that requires a special diet,
• pregnancy and lactation,
• excess physical activity (>5h/week of high intensity),
• current participation in another trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of protein intake	7 days	Agreement between mean protein intake per day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and nitrogen excretion in a 24-hr urine sample (urea corrected for creatine).

Secondary Outcome Measures

Name	Time	Method
Validation of energy intake	7 days	Agreement between mean energy intake per day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and resting metabolic rate (measured by ventilated hood).
Validation of vegetable and fruit intake	7 days	Agreement between mean intake of vegetable and fruit per day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and concentration of folate in a fasting blood sample.
Validation of alcohol intake	7 days	Agreement between mean alcohol intake pr day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and excretion of ethanol and ethyl conjugates in a 24-hr urine sample.
Validation of coffee intake	7 days	Agreement between mean coffee intake per day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and excretion of trigonelline and cyclo(isoleucylprolyl) in a 24-hr urine sample.
Reproducibility of dietary registration	Two times 4 weeks (+/- 1 week) apart	Agreement between two dietary intake measurements assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) obtained 4 (± 1 week) apart.
Validation of whole grain intake	7 days	Agreement between intake of whole grain per day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and excretion of alkylresorcinols in a fasting blood sample.

Trial Locations

Locations (1)

University of Copenhagen; 🇩🇰 Frederiksberg, DK, Denmark