Validation of a Nutrient Profiling System for Reformulation

January 25, 2018 updated by: Société des Produits Nestlé (SPN)

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

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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

6991

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Representative samples of the US and French adult populations

Description

Inclusion Criteria:

  • All participants of INCA2 and NHANES 2011-12 surveys

Exclusion Criteria:

  • Missing dietary intake data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Kathryn Porter, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Actual)

December 31, 2012

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJCN/2017/172213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The NHANES 2011-12 and INCA2 data are available to other researchers via the respective websites.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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