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Completed

NCT Number: NCT03138330

Validation of a Food Frequency Questionnaire

The purpose of this study is to collect nutritional information from young children aged 15-36 months to validate a newly developed food frequency questionnaire.

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Key information

Conditions

Nutrition

Age range

15 month–36 month

Sex eligibility

All sexes

Study type

Observational

About this study

The primary purpose of this study is to validate a semi-quantitative food frequency questionnaire (FFQ) against a reference method (2-day weighed food records) in a sample of young children aged 15-36 months.

In addition to dietary data, the investigators also collected information on parental demographics, toddler health with regards to allergies and intolerance, parental feeding practices, parent and child weight and height and lastly, saliva samples to study inflammatory markers.

Therefore, in addition to the validation of the FFQ- the data will also be used to study associations between dietary patterns, food and nutrient intake and (i) parental feeding practices and (ii) inflammatory biomarkers from saliva

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 15-36 months old boys and girls who are healthy
  • Toddlers who are from either Chinese, Malay or Indian ethnic group

Exclusion criteria

  • Toddlers with any acute or chronic illness, such as chronic inflammatory bowel disease, or illness that negatively affects food intake (e.g. Crohn's disease or ulcerative colitis).
  • Toddlers with history of antibiotics used in the last 1 week before the study.
  • Toddlers with history of vaccination in the last 2 weeks before the study
  • Toddlers with one or both parents of Caucasian origin.

Treatment and study plan

this study is observational, it is not an intervention

Other

Primary outcomes

  1. Validated Food Frequency Questionnaire

    Time frame: up to 1 month

    Ninety-one parents completed the sqFFQ and a 2-day weighed food record as the reference method. Intake of energy and nutrients (energy, carbohydrates, fat, protein, fibre, sugars, calcium and iron) were determined for each method and compared using Pearson correlations.

Secondary outcomes

  1. Salivary Inflammatory Biomarkers

    Time frame: up to 1 month

    C-reactive protein, salivary IgA, alpha amylase

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Registry information

Official study title

Validation of Dietary Patterns and Inflammatory Salivary Biomarkers Among Healthy Toddlers of 15-36 Months Old in Singapore

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 3, 2017
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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