- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03411603
Validation of a Nutrient Profiling System for Reformulation
Food and Diet Based Validations of a Nutrient Profiling System for Reformulation in Two Nationally Representative Surveys
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: The Nestlé Nutritional Profiling System (NNPS) has been developed to guide food and beverage reformulation. It is not known whether products passing the NNPS standards have a higher overall nutritional density, and whether the higher consumption of NNPS Pass products is associated with a higher dietary quality.
Objective: The objectives were (i) to compare the classifications derived from the NNPS and the validated UK Ofcom nutrient profiling system; and (ii) to assess the NNPS construct validity against healthy and unhealthy diets in French (Individual and National Survey on food Consumption 2006-2007) and the US (National Health and Nutrition Examination Surveys 2011-2012) nationally representative dietary surveys.
Design: NNPS outcomes (PASS, FAIL, Out-of-scope) of foods were compared to UK Ofcom outcomes. Contributions of NNPS outcomes to energy intakes were compared between diets nutritional quality classes defined by two methods: based on a food-based quality indicator (PNNS-GS in France, HEI-2010 in the US), or on a combination of three nutrient-based indicators (MAR, MER, energy density).
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All participants of INCA2 and NHANES 2011-12 surveys
Exclusion Criteria:
- Missing dietary intake data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
INCA2 2006-07
French National Dietary Intake Survey, conducted in 2006-2007 by the French Agency for Food, Environmental and Occupational Health Safety. Adults aged 18y and over, n=1918 included in the analyses. |
24-hr recall or food diary questionnaires; socio-demographic questionnaires
|
|
NHANES 2011-12
Wave 2011-12 of the National Health and Nutrition Examination Survey, the US national dietary intake Survey, conducted by the Centers for Disease Control and Prevention (CDC) Adults aged 18y and over, n=5073 included in the analyses.
|
24-hr recall or food diary questionnaires; socio-demographic questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthy Eating Index 2010
Time Frame: 2011-12
|
Measure of dietary quality for the NHANES Survey, based on reported dietary intakes
|
2011-12
|
|
PNNS-GS diet score
Time Frame: 2006-07
|
Measure of dietary quality for the French INCA2 Survey, based on reported dietary intakes
|
2006-07
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Adequacy Ratio
Time Frame: 2006-07 and 2011-12
|
Measure of individuals nutrient adequacy based on reported food intakes
|
2006-07 and 2011-12
|
|
Mean Excess Ratio
Time Frame: 2006-07 and 2011-12
|
Measure of excessive nutrient consumption, based on reported food intakes
|
2006-07 and 2011-12
|
|
Energy density
Time Frame: 2006-07 and 2011-12
|
Solid energy density of diets, based on reported food intakes
|
2006-07 and 2011-12
|
Collaborators and Investigators
Investigators
- Study Director: Kathryn Porter, Centers for Disease Control and Prevention
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJCN/2017/172213
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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