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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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
Primary outcomes
-
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
-
Salivary Inflammatory Biomarkers
Time frame: up to 1 month
C-reactive protein, salivary IgA, alpha amylase
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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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