Development of a Total Nutrient Index

January 12, 2018 updated by: Regan Bailey, National Institute of Health and Nutrition
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Children (</=18 years) and adults (>/=19 years) will be examined separately given the differential usage patterns in frequency and type of dietary supplements.

Exclusion Criteria:

  • Pregnant and lactating females will be excluded from analysis because they are more likely to use dietary supplements than the general population.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
NHANES 2011 to 2014

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Health and Nutrition

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Purdue University

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCIR01_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

NHANES data are publicly available

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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