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Validation of a Food Frequency Questionnaire

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03138330
Enrollment
95
Registered
2017-05-03
Start date
2015-12-31
Completion date
2016-12-31
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition

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.

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

Interventions

OTHERthis study is observational, it is not an intervention

Sponsors

Danone Asia Pacific Holdings Pte, Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
15 Months to 36 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Validated Food Frequency Questionnaireup to 1 monthNinety-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

MeasureTime frameDescription
Salivary Inflammatory Biomarkersup to 1 monthC-reactive protein, salivary IgA, alpha amylase

Participant flow

Participants by arm

ArmCount
FFQ Group
The study included toddlers of 15-39 months of age of Chinese, Malay, or Indian ethnicity in Singapore.
91
Total91

Baseline characteristics

CharacteristicFFQ Group
Age, Categorical
<=18 years
91 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous23 months
STANDARD_DEVIATION 7
Region of Enrollment
Singapore
91 participants
Sex: Female, Male
Female
47 Participants
Sex: Female, Male
Male
44 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 91
other
Total, other adverse events
0 / 91
serious
Total, serious adverse events
0 / 91

Outcome results

Primary

Validated Food Frequency Questionnaire

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.

Time frame: up to 1 month

Population: Ninety-one parents of Singaporean toddlers who completed the sqFFQ and a 2-day weighed food record. Here pearson correlation between the two methods (FFQ and food diary) is presented.

ArmMeasureGroupValue (NUMBER)
FFQ GroupValidated Food Frequency Questionnairetotal Energy0.39 Pearson correlation
FFQ GroupValidated Food Frequency QuestionnaireProtein0.35 Pearson correlation
FFQ GroupValidated Food Frequency Questionnairetotal fat0.28 Pearson correlation
FFQ GroupValidated Food Frequency Questionnairetotal carbohydrates0.32 Pearson correlation
FFQ GroupValidated Food Frequency Questionnairesugars0.42 Pearson correlation
FFQ GroupValidated Food Frequency Questionnairefibre0.56 Pearson correlation
FFQ GroupValidated Food Frequency QuestionnaireCalcium0.62 Pearson correlation
FFQ GroupValidated Food Frequency QuestionnaireIron0.28 Pearson correlation
Secondary

Salivary Inflammatory Biomarkers

C-reactive protein, salivary IgA, alpha amylase

Time frame: up to 1 month

Population: Subjects who had sufficient saliva sample for analysis. There was not sufficient saliva sample to measure the CRP values, thus CRP values are not reported.

ArmMeasureGroupValue (MEAN)Dispersion
FFQ GroupSalivary Inflammatory BiomarkersIgA119314 ug/mlStandard Deviation 157368
FFQ GroupSalivary Inflammatory BiomarkersAmylase79 ug/mlStandard Deviation 60

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026