Validation of a Nutrient Profiling System for Reformulation

Nutrition Poor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411603
• Other study ID #: AJCN/2017/172213
• Status: Completed
• Phase: N/A
• First received: January 11, 2018
• Last updated: January 25, 2018
• Start date: January 1, 2006
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6991
• Est. completion date: December 1, 2017
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All participants of INCA2 and NHANES 2011-12 surveys

Exclusion Criteria:

• Missing dietary intake data

Related Conditions & MeSH terms

• Malnutrition
• Nutrition Poor

Intervention

Other:
• Diet and socio-demographic questionnaires
24-hr recall or food diary questionnaires; socio-demographic questionnaires

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthy Eating Index 2010	Measure of dietary quality for the NHANES Survey, based on reported dietary intakes	2011-12
Primary	PNNS-GS diet score	Measure of dietary quality for the French INCA2 Survey, based on reported dietary intakes	2006-07
Secondary	Mean Adequacy Ratio	Measure of individuals nutrient adequacy based on reported food intakes	2006-07 and 2011-12
Secondary	Mean Excess Ratio	Measure of excessive nutrient consumption, based on reported food intakes	2006-07 and 2011-12
Secondary	Energy density	Solid energy density of diets, based on reported food intakes	2006-07 and 2011-12

External Links

•   Details of French dietary surveys. ANSES website
•   NHANES website