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Completed

NCT Number: NCT03411603

Validation of a Nutrient Profiling System for Reformulation

The objectives of the study are to assess the validity of Nestlé reformulation criteria in two national dietary surveys: the US NHANES 2011, and the French INCA2 2006-07.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All participants of INCA2 and NHANES 2011-12 surveys

Exclusion criteria

  • Missing dietary intake data

Treatment and study plan

Diet and socio-demographic questionnaires

Other

24-hr recall or food diary questionnaires; socio-demographic questionnaires

Primary outcomes

  1. Healthy Eating Index 2010

    Time frame: 2011-12

    Measure of dietary quality for the NHANES Survey, based on reported dietary intakes

  2. PNNS-GS diet score

    Time frame: 2006-07

    Measure of dietary quality for the French INCA2 Survey, based on reported dietary intakes

Secondary outcomes

  1. Mean Adequacy Ratio

    Time frame: 2006-07 and 2011-12

    Measure of individuals nutrient adequacy based on reported food intakes

  2. Mean Excess Ratio

    Time frame: 2006-07 and 2011-12

    Measure of excessive nutrient consumption, based on reported food intakes

  3. Energy density

    Time frame: 2006-07 and 2011-12

    Solid energy density of diets, based on reported food intakes

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Food and Diet Based Validations of a Nutrient Profiling System for Reformulation in Two Nationally Representative Surveys

Important dates

Study start
2006
Primary completion
2012
Study completion
2017
First posted
Jan 26, 2018
Registry last updated
Jan 26, 2018

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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