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Validation of a Food Frequency Questionnaire

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ClinicalTrials.gov Identifier: NCT03138330
Recruitment Status : Completed
First Posted : May 3, 2017
Results First Posted : April 2, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Nutrition Other: this study is observational, it is not an intervention

Detailed Description:

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

Study Design
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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of Dietary Patterns and Inflammatory Salivary Biomarkers Among Healthy Toddlers of 15-36 Months Old in Singapore
Actual Study Start Date : December 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 31, 2016
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Salivary Inflammatory Biomarkers [ Time Frame: up to 1 month ]
    C-reactive protein, salivary IgA, alpha amylase


Biospecimen Retention:   Samples Without DNA
saliva

Eligibility Criteria
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Ages Eligible for Study:   15 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children who are aged 15-36 months and of Chinese, Indian or Malay ethnicity
Criteria

Inclusion Criteria:

  1. 15-36 months old boys and girls who are healthy
  2. Toddlers who are from either Chinese, Malay or Indian ethnic group

Exclusion Criteria:

  1. 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).
  2. Toddlers with history of antibiotics used in the last 1 week before the study.
  3. Toddlers with history of vaccination in the last 2 weeks before the study
  4. Toddlers with one or both parents of Caucasian origin.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138330


Sponsors and Collaborators
Danone Asia Pacific Holdings Pte, Ltd.
Investigators
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Principal Investigator: Elena Sandalova, PhD Danone Nutricia Early Life Nutrition
Study Chair: Smita Nambiar-Mann, PhD Danone Nutricia Early Life Nutrition
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT03138330    
Other Study ID Numbers: SGP. 1.A/A/3, PIEC2015/023.
First Posted: May 3, 2017    Key Record Dates
Results First Posted: April 2, 2020
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: the whole data set (without traceability to the participant) may be available for other researchers for secondary analyses

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No