Diet HabitNCT03400436
Development of a Total Nutrient Index
An observational study of Diet Habit, run by National Institute of Health and Nutrition.
Trial summary
Dietary supplements are an important contributor to overall nutrient exposures for a large proportion of the U.S. population. Currently no standardized method exists to measure their use and contribution to total nutrient intakes, substantially limiting the rigor and reproducibility of their measurement. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diet Habit
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The NHANES is a nationally representative, cross-sectional continuous survey that includes non-institutionalized, civilian U.S. residents using a complex, stratified, multistage probability cluster sampling design. The NHANES data are publicly available and are released in 2-year datasets to ensure confidentiality of the participants and to allow for adequate sample size for statistical analysis. The NHANES data are planned and collected by the National Center for Health Statistics of the Centers for Disease Control and Prevention. Written informed consent is obtained for all participants or proxies and the survey protocol is approved by the research ethics review board at the National Center for Health Statistics. Currently, we plan to use NHANES 2011-2012 and 2013-2014 data cycles because these are the first to include oversampling of non-Hispanic Asian Americans and have supplement intake data collected on both the 24HRs and the 30-day frequency questionnaire.
Who may be able to join
- Children (</=18 years) and adults (>/=19 years) will be examined separately given the differential usage patterns in frequency and type of dietary supplements.
Who cannot join
- Pregnant and lactating females will be excluded from analysis because they are more likely to use dietary supplements than the general population.
About this study
Dietary supplements are an important contributor to overall nutrient exposures for a large proportion of the U.S. population. Currently no standardized method exists to measure their use and contribution to total nutrient intakes, substantially limiting the rigor and reproducibility of their measurement. The purpose of this proposed project is to develop a standardized, data-driven, and valid metric that can be to measure use of and nutrient exposures from dietary supplements for use in research, clinical, and monitoring settings.
Read the detailed description
Diet is a modifiable exposure that can positively or negatively impact health. More than half of adults and one-third of children use dietary supplements that contain nutrients critical to human health. Currently no metric exists to measure overall total nutrient exposures from all sources. Without measuring the contribution of dietary supplements, exposure classification is incomplete both for nutrient inadequacy and nutrient excess. Our highly qualified team proposes to develop the first comprehensive total nutrient index using a data-driven strategy with the nationally-representative National Health and Nutrition Examination Survey (NHANES). Indexes and scores are the preferred metric for use in nutrition because this method provides a standardized framework to compare across studies. In fact, the 2015 Dietary Guidelines for Americans Advisory Committee report, building on systematic reviews from the USDA Nutrition Evidence Library, were able to conclude that only diet classified by indexes and scores were useful for informing nutrition policy. The synthesis of the data in report yielded strong and consistent evidence for dietary patterns classified by indexes and scores and cardiovascular disease and weight status, and moderate evidence for dietary patterns and type 2 diabetes. However, no index or score is available that accounts for nutrients derived from dietary supplements and medications. In Aim 1, the investigators will develop a usual intake model that captures habitual intakes from food, beverages, dietary supplements, and medication, mitigiating the measurement error to the extent possible with self-reported dietary intakes. In Aim 2, the investigators will characterize the patterns of nutrients intake using data reduction techniques to create the most salient items to include in the index. The patterns will be carefully examined with regard to biomarkers, health behaviors, and measures of bone and body composition to create a scoring algorithm for the total nutrient index. In Aim 3, the investigators will test the reliability and the validity of the total nutrient index. The purpose of the total nutrient index is to provide a tool that can be used for research, monitoring, and policy purposes. Improving measures of dietary exposure will improve our ability to show causal links to health, ultimately enabling successful intervention strategies, and the use of the NHANES data to develop the total nutrient index greatly enhances its external validity.
- Conditions
- Diet Habit
- Being tested
- No intervention in observational studies
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention in observational studiesOther
No intervention in observational studies
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient quality index
This study will develop the nutrient quality index; this will be the tool used to measure nutrient quality in other studies.
Measured: NHANES 2011 to 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study startJan 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Health and Nutrition
- Sponsor type
- Other government
- Collaborators
- Purdue University
- Responsible party
- Principal investigator, Regan Bailey, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400436
- Sponsor's protocol ID
- NCIR01_1
- Status last verified
- Jan 2018
- First submitted
- 2 Nov 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NHANES data are publicly available
Publications
Jun S, Cowan AE, Dodd KW, Tooze JA, Gahche JJ, Eicher-Miller HA, Guenther PM, Dwyer JT, Potischman N, Bhadra A, Forman MR, Bailey RL. Association of food insecurity with dietary intakes and nutritional biomarkers among US children, National Health and Nutrition Examination Survey (NHANES) 2011-2016. Am J Clin Nutr. 2021 Sep 1;114(3):1059-1069. doi: 10.1093/ajcn/nqab113.
PubMed 33964856Cowan AE, Jun S, Tooze JA, Dodd KW, Gahche JJ, Eicher-Miller HA, Guenther PM, Dwyer JT, Moshfegh AJ, Rhodes DG, Bhadra A, Bailey RL. Comparison of 4 Methods to Assess the Prevalence of Use and Estimates of Nutrient Intakes from Dietary Supplements among US Adults. J Nutr. 2020 Apr 1;150(4):884-893. doi: 10.1093/jn/nxz306.
PubMed 31851315Bailey RL, Dodd KW, Gahche JJ, Dwyer JT, Cowan AE, Jun S, Eicher-Miller HA, Guenther PM, Bhadra A, Thomas PR, Potischman N, Carroll RJ, Tooze JA. Best Practices for Dietary Supplement Assessment and Estimation of Total Usual Nutrient Intakes in Population-Level Research and Monitoring. J Nutr. 2019 Feb 1;149(2):181-197. doi: 10.1093/jn/nxy264.
PubMed 30753685
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Total Nutrient Index
- ClinicalTrials.gov ID
- NCT03400436
- Acronym / sponsor ID
- NCIR01_1
- Conditions
- Diet Habit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- National Institute of Health and NutritionOther government
- Collaborators
- Purdue University
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 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.
Dietary supplements are an important contributor to overall nutrient exposures for a large proportion of the U.S. population. Currently no standardized method exists to measure their use and contribution to total nutrient intakes, substantially limiting the rigor and reproducibility of their measurement. The purpose of this proposed project is to develop a standardized, data-driven, and valid metric that can be to measure use of and nutrient exposures from dietary supplements for use in research, clinical, and monitoring settings.
Detailed description
Diet is a modifiable exposure that can positively or negatively impact health. More than half of adults and one-third of children use dietary supplements that contain nutrients critical to human health. Currently no metric exists to measure overall total nutrient exposures from all sources. Without measuring the contribution of dietary supplements, exposure classification is incomplete both for nutrient inadequacy and nutrient excess. Our highly qualified team proposes to develop the first comprehensive total nutrient index using a data-driven strategy with the nationally-representative National Health and Nutrition Examination Survey (NHANES). Indexes and scores are the preferred metric for use in nutrition because this method provides a standardized framework to compare across studies. In fact, the 2015 Dietary Guidelines for Americans Advisory Committee report, building on systematic reviews from the USDA Nutrition Evidence Library, were able to conclude that only diet classified by indexes and scores were useful for informing nutrition policy. The synthesis of the data in report yielded strong and consistent evidence for dietary patterns classified by indexes and scores and cardiovascular disease and weight status, and moderate evidence for dietary patterns and type 2 diabetes. However, no index or score is available that accounts for nutrients derived from dietary supplements and medications. In Aim 1, the investigators will develop a usual intake model that captures habitual intakes from food, beverages, dietary supplements, and medication, mitigiating the measurement error to the extent possible with self-reported dietary intakes. In Aim 2, the investigators will characterize the patterns of nutrients intake using data reduction techniques to create the most salient items to include in the index. The patterns will be carefully examined with regard to biomarkers, health behaviors, and measures of bone and body composition to create a scoring algorithm for the total nutrient index. In Aim 3, the investigators will test the reliability and the validity of the total nutrient index. The purpose of the total nutrient index is to provide a tool that can be used for research, monitoring, and policy purposes. Improving measures of dietary exposure will improve our ability to show causal links to health, ultimately enabling successful intervention strategies, and the use of the NHANES data to develop the total nutrient index greatly enhances its external validity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The NHANES is a nationally representative, cross-sectional continuous survey that includes non-institutionalized, civilian U.S. residents using a complex, stratified, multistage probability cluster sampling design. The NHANES data are publicly available and are released in 2-year datasets to ensure confidentiality of the participants and to allow for adequate sample size for statistical analysis. The NHANES data are planned and collected by the National Center for Health Statistics of the Centers for Disease Control and Prevention. Written informed consent is obtained for all participants or proxies and the survey protocol is approved by the research ethics review board at the National Center for Health Statistics. Currently, we plan to use NHANES 2011-2012 and 2013-2014 data cycles because these are the first to include oversampling of non-Hispanic Asian Americans and have supplement intake data collected on both the 24HRs and the 30-day frequency questionnaire.
Key inclusion criteria (1 listed)
- Children (</=18 years) and adults (>/=19 years) will be examined separately given the differential usage patterns in frequency and type of dietary supplements.
Key exclusion criteria (1 listed)
- Pregnant and lactating females will be excluded from analysis because they are more likely to use dietary supplements than the general population.
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 |
|---|---|---|
| No intervention in observational studiesNo intervention in observational studies | Other | – |
Primary outcome
Nutrient quality index
Time frame: NHANES 2011 to 2014
This study will develop the nutrient quality index; this will be the tool used to measure nutrient quality in other studies.
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 17 Jan 2018.
- Derived from this study: PubMed 33964856Jun S, Cowan AE, Dodd KW, Tooze JA, Gahche JJ, Eicher-Miller HA, Guenther PM, Dwyer JT, Potischman N, Bhadra A, Forman MR, Bailey RL. Association of food insecurity with dietary intakes and nutritional biomarkers among US children, National Health and Nutrition Examination Survey (NHANES) 2011-2016. Am J Clin Nutr. 2021 Sep 1;114(3):1059-1069. doi: 10.1093/ajcn/nqab113.
- Derived from this study: PubMed 31851315Cowan AE, Jun S, Tooze JA, Dodd KW, Gahche JJ, Eicher-Miller HA, Guenther PM, Dwyer JT, Moshfegh AJ, Rhodes DG, Bhadra A, Bailey RL. Comparison of 4 Methods to Assess the Prevalence of Use and Estimates of Nutrient Intakes from Dietary Supplements among US Adults. J Nutr. 2020 Apr 1;150(4):884-893. doi: 10.1093/jn/nxz306.
- Derived from this study: PubMed 30753685Bailey RL, Dodd KW, Gahche JJ, Dwyer JT, Cowan AE, Jun S, Eicher-Miller HA, Guenther PM, Bhadra A, Thomas PR, Potischman N, Carroll RJ, Tooze JA. Best Practices for Dietary Supplement Assessment and Estimation of Total Usual Nutrient Intakes in Population-Level Research and Monitoring. J Nutr. 2019 Feb 1;149(2):181-197. doi: 10.1093/jn/nxy264.
- Individual participant dataSharing planned: No. NHANES data are publicly available
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit, run by National Institute of Health and Nutrition.
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 17 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?
Nutrient quality index (time frame: NHANES 2011 to 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400436, which also lists 3 linked publications.
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 17 Jan 2018.