Nutrition PoorNCT03411603
Validation of a Nutrient Profiling System for Reformulation
An observational study of Nutrition Poor, run by Société des Produits Nestlé (SPN).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition Poor
- What is being tested?
- Diet and socio-demographic questionnaires
- How many people
- 6,991 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Representative samples of the US and French adult populations
Who may be able to join
- All participants of INCA2 and NHANES 2011-12 surveys
Who cannot join
- Missing dietary intake data
About this study
Official title: 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.
Read the 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).
- Conditions
- Nutrition Poor
- Being tested
- Diet and socio-demographic questionnaires
- Keywords
- nutrient profiling
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and socio-demographic questionnairesOther
24-hr recall or food diary questionnaires; socio-demographic questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diet and 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. Receives: Other: Diet and socio-demographic questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Eating Index 2010
Measure of dietary quality for the NHANES Survey, based on reported dietary intakes
Measured: 2011-12
PNNS-GS diet score
Measure of dietary quality for the French INCA2 Survey, based on reported dietary intakes
Measured: 2006-07
Secondary outcomes (3)
Mean Adequacy Ratio
Measure of individuals nutrient adequacy based on reported food intakes
Measured: 2006-07 and 2011-12
Mean Excess Ratio
Measure of excessive nutrient consumption, based on reported food intakes
Measured: 2006-07 and 2011-12
Energy density
Solid energy density of diets, based on reported food intakes
Measured: 2006-07 and 2011-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Jan 2006
- Primary completion31 Dec 2012
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition PoorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 6,991 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathryn Porter, Study director, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411603
- Sponsor's protocol ID
- AJCN/2017/172213
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The NHANES 2011-12 and INCA2 data are available to other researchers via the respective websites.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food and Diet Based Validations of a Nutrient Profiling System for Reformulation in Two Nationally Representative Surveys
- ClinicalTrials.gov ID
- NCT03411603
- Acronym / sponsor ID
- AJCN/2017/172213
- Conditions
- Nutrition Poor
- Keywords
- nutrient profiling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,991 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCA2 2006-07 | – | Other: Diet and socio-demographic questionnairesFrench 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. |
| NHANES 2011-12 | – | Other: Diet and socio-demographic questionnairesWave 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Representative samples of the US and French adult populations
Key inclusion criteria (1 listed)
- All participants of INCA2 and NHANES 2011-12 surveys
Key exclusion criteria (1 listed)
- Missing dietary intake data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and socio-demographic questionnaires24-hr recall or food diary questionnaires; socio-demographic questionnaires | Other | INCA2 2006-07, NHANES 2011-12 |
Primary outcome
Healthy Eating Index 2010
Time frame: 2011-12
Measure of dietary quality for the NHANES Survey, based on reported dietary intakes
PNNS-GS diet score
Time frame: 2006-07
Measure of dietary quality for the French INCA2 Survey, based on reported dietary intakes
3 secondary outcomes
Mean Adequacy Ratio
Time frame: 2006-07 and 2011-12
Mean Excess Ratio
Time frame: 2006-07 and 2011-12
Energy density
Time frame: 2006-07 and 2011-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Details of French dietary surveys. ANSES websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. The NHANES 2011-12 and INCA2 data are available to other researchers via the respective websites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Porter study director
Centers for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Poor, run by Société des Produits Nestlé (SPN).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Eating Index 2010 (time frame: 2011-12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.