Validity and Reproducibility of Dietary Assessment Against Objective Measures

Validation Study Clinical Trial

— VALID  

Official title:

Validity and Reproducibility of A Self-administered Web-based 24-hour Dietary Assessment Tool Among Danish Adults Against Objective Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05600530
• Other study ID #: M243
• Status: Completed
• Start date: October 31, 2022
• Est. completion date: August 25, 2023

Study information

• Verified date: October 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion criteria:

• Apparently healthy adults between 35 and 70 years old

• Body mass index (BMI) between 22-32 kg/m2

• Weight stable defined as gain or loss of < 2.5% body weight during the past 3 months;

• Willingness to maintain current dietary and physical activity habits throughout the study period.

• Have high-speed internet access;

• Able to speak, read and write Danish;

• Willing to visit the Department of Nutrition, Exercise, and Sports (NEXS).

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

Related Conditions & MeSH terms

• Validation Study

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Frederiksberg	DK

Sponsors (1)

Lead Sponsor	Collaborator
Inge Tetens

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of protein intake	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).	7 days
Secondary	Validation of energy intake	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).	7 days
Secondary	Validation of vegetable and fruit intake	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.	7 days
Secondary	Validation of whole grain intake	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.	7 days
Secondary	Validation of alcohol intake	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.	7 days
Secondary	Validation of coffee intake	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.	7 days
Secondary	Reproducibility of dietary registration	Agreement between two dietary intake measurements assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) obtained 4 (± 1 week) apart.	Two times 4 weeks (+/- 1 week) apart