NCT05610137

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

October 20, 2022

Last Update Submit

July 19, 2024

Conditions

Keywords

Dietary intake24-hour recallBiomarkers

Outcome Measures

Primary Outcomes (1)

  • The extent of agreement between the 24-hour dietary recall assisted with digital photography and food weighing in energy and nutrient reporting.

    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 Outcomes (12)

  • The average protein intake (g/day)

    Through study completion, an avarege of 1 month

  • The average sodium intake (mg/day)

    Through study completion, an avarege of 1 month

  • The average potassium intake (mg/day)

    Through study completion, an avarege of 1 month

  • The average plasma vitamin C (mg/dL)

    Through study completion, an avarege of 1 month

  • The average plasma vitamin B1 (nmol/L)

    Through study completion, an avarege of 1 month

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vidarium, Nutrition, Health and Wellness Research Center

MedellĂ­n, Antioquia, 050023, Colombia

Location

Related Publications (49)

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Biospecimen

Retention: SAMPLES WITH DNA

Feces

Study Officials

  • Vanessa Corrales Aguadelo, Msc

    Vidarium, Research Center on Nutrition, Health and Wellness - Nutresa Business Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 20, 2022

First Posted

November 9, 2022

Study Start

October 18, 2022

Primary Completion

December 15, 2022

Study Completion

December 30, 2022

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

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)

Shared Documents
SAP, CSR, ANALYTIC CODE
Time Frame
The data will be available when the results are published.
Access Criteria
Public

Locations