Application of the 24-hour Recall Methodology Assisted by Digital Photographs for the Analysis of Dietary Intake (IngFood)

January 17, 2023 updated by: Vanessa Corrales Agudelo

Application of the 24-hour Recall Methodology Assisted by Digital Photographs and Homologation With Colombian Foods for the Analysis of Dietary Intake

With this project, the investigators expect to standardize a reliable and optimized methodology based on a 24-hour recall tool assisted by digital photographs with a complete output of foods and nutritional information for the Colombian population.

Study Overview

Status

Completed

Conditions

Detailed Description

After recruitment, participants (20) will receive a detailed explanation of the objectives and conditions of the study and will sign the informed consent. Dietary intake assessments will be conducted using 24-hour dietary recalls, assisted with digital photographs registry of the food and beverages consumed, and a brief description (the two 24 dietary recalls will be applied on different and non-consecutive days). Simultaneously, food weighing using a home kitchen scale and drink volume measurements will be used as a reference. For the analysis of nutritional information, the daily food intake extracted from food photologs will be entered into the automated Self-Administered Dietary Assessment Tool (ASA24®). Macro- and micronutrient intake using the actual food weights recorded by the participants, will be estimated from the USDA FNDDS 2017-2018 database, and polyphenols composition from a phenol database.

On the day of each 24-h dietary recall, participants will collect a 24-h urine sample to assess their protein, sodium, and potassium intake. Additionally, the day after each 24 dietary recall, participants will also provide blood samples to determine circulating levels of vitamin C, vitamin B1, vitamin K1, folate, zinc, copper, and beta-carotene; and fecal samples to identify vegetable species in feces.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050023
        • Vidarium, Nutrition, Health and Wellness Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Twenty subjects, general population. Participants should not change their dietary habits during the study.

Description

Inclusion Criteria:

  • Men and women older than 18 years
  • Who owns a smartphone.
  • Autonomous in the use of a smartphone.
  • With internet access.

Exclusion Criteria:

  • Subjects who do not photograph the food and/or do not record them.
  • Subjects that do not accept the interview for the clarification of doubts related to the food after the photographic report.
  • People who can not stay at home for at least the evaluation days to facilitate the weighing of food.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The extent of agreement between the 24-hour dietary recall assisted with digital photography and food weighing in energy and nutrient reporting.
Time Frame: Through study completion, an avarege of 1 month
The average of the two 24 hour periods within each method. Bland Altman analysis of energy and macronutrient (carbohydrates, fat, protein) intake.
Through study completion, an avarege of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The average protein intake (g/day)
Time Frame: Through study completion, an avarege of 1 month
Protein intake is estimated based on the concept that nitrogen-containing products of dietary protein plus nitrogenous products of endogenous protein breakdown are excreted as either urea or non-urea nitrogen. The urea nitrogen appearance (UNA) rate is measured as the amount of urea excreted in urine plus the net amount accumulated in body water. Protein intake is urine nitrogen excreted in grams/day + (weight in kilograms X 0.031g nitrogen/kg/day) multiplied by 6.25. These calculated values are very close to actual nitrogen or protein intake values.
Through study completion, an avarege of 1 month
The average sodium intake (mg/day)
Time Frame: Through study completion, an avarege of 1 month
24-hour urinary sodium excretion is the most accurate estimate of daily sodium intake and is not subject to recall bias. About 90% of the sodium consumed (from all sources) is excreted in the urine. Sodium intake (mg/day) is sodium in 24-h urine (adjusted for % of intake excreted in urine) multiplied by the total urine volume.
Through study completion, an avarege of 1 month
The average potassium intake (mg/day)
Time Frame: Through study completion, an avarege of 1 month
24-hour urinary potassium excretion is the most accurate estimate of daily intake and is not subject to recall bias. Therefore, potassium intake (mg/day) is potassium in 24-h urine (adjusted for % of intake excreted in urine) multiplied by the total urine volume.
Through study completion, an avarege of 1 month
The average plasma vitamin C (mg/dL)
Time Frame: Through study completion, an avarege of 1 month
Humans, unlike most animals, are unable to synthesize vitamin C endogenously, so it is an essential dietary component. Plasma levels of this vitamin commonly measured by HPLC are considered as circulating values of the micronutrient and represent the recent intake. References values range 0.4-2.0 mg/dL
Through study completion, an avarege of 1 month
The average plasma vitamin B1 (nmol/L)
Time Frame: Through study completion, an avarege of 1 month
Levels of this vitamin measured by High-Performance Liquid Chromatography (HPLC) in blood is a sensitive, specific, and precise method for determining the nutritional status of thiamine. Thiamine is obtained from the diet and body stores are limited. Circulating values of the micronutrient and represent the recent intake. References values range 70-180 nmol/L
Through study completion, an avarege of 1 month
The average plasma vitamin K1 (phylloquinone) (ng/mL)
Time Frame: Through study completion, an avarege of 1 month
The concentration of this vitamin measured by High-Performance Liquid Chromatography (HPLC) in fasting serum is a strong indicator of dietary intake and status. Circulating values of the micronutrient and representing the recent intake. References values in adults > 18 years range: 0.10-2.20 ng/mL.
Through study completion, an avarege of 1 month
The average serum folate (N-(5)-methyl tetrahydrofolate) (ug/L)
Time Frame: Through study completion, an avarege of 1 month
Approximately 20% of the folate absorbed daily is derived from dietary sources; the remainder is synthesized by intestinal microorganisms. The level of this vitamin is measured by chemiluminescent immunoassay and is a strong indicator of dietary intake. Normal or elevated circulating values of this micronutrient represent the recent intake. Reference values in adults are ≥ 4.0 ug/L.
Through study completion, an avarege of 1 month
The average serum copper (ug/dL)
Time Frame: Through study completion, an avarege of 1 month
The concentration of this microelement is measured by flame atomic absorption spectrometry and is a strong indicator of dietary intake. Values of this micronutrient represent the recent intake. Reference values in adults range from 73-129 ug/dL in Males: and 77-206 ug/dL in females
Through study completion, an avarege of 1 month
The average serum zinc ug/dL
Time Frame: Through study completion, an avarege of 1 month
Zinc is obtained entirely from the diet; it is analyzed in serum by inductively coupled plasma-mass spectrometry and is a strong indicator of dietary intake. Values of this micronutrient represent the recent intake. Normal serum zinc levels range from 66 to 106 ug/dL in adults.
Through study completion, an avarege of 1 month
The average beta-carotene (ug/dL)
Time Frame: Through study completion, an avarege of 1 month
Beta-carotene, a fat-soluble nutrient, is a precursor to vitamin A and is analyzed in serum spectrometry and is a reflection of the quantities of carotene (provitamin A) ingested and absorbed by the intestine. Values of this micronutrient represent the recent intake. Normal serum beta-carotene levels range 4-51 ug/dL in males: and 6-77 ug/dL in females.
Through study completion, an avarege of 1 month
The average polyphenols intake (mg/GAE/day)
Time Frame: Through study completion, an avarege of 1 month
Polyphenols are an important class of phytochemicals related with health. They will be estimated from the 24 dietary recalls coupled with a food polyphenols database.
Through study completion, an avarege of 1 month
The average abundance vegetable species in the stool
Time Frame: Through study completion, an avarege of 1 month
High-throughput sequencing technologies have provided an efficient approach for assessing plant diversity combining various bioinformatics pipelines to assign DNA sequences into species.
Through study completion, an avarege of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanessa Corrales Agudelo

Investigators

  • Principal Investigator: Vanessa Corrales Aguadelo, Msc, Vidarium, Research Center on Nutrition, Health and Wellness - Nutresa Business Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 9, 2022

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FC001-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data will be available when the results are published. The data can be obtained by downloading from the cloud (ex: NCBI-SRA or Github)

IPD Sharing Time Frame

The data will be available when the results are published.

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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