Development of a Total Nutrient Index

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: Completed
• Conditions: Diet Habit
• Intervention / Treatment: Other: No intervention in observational studies

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: Observational
• Enrollment (Actual): 10000

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrient quality index	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

• Sponsor: National Institute of Health and Nutrition
• Collaborators: Purdue University

Publications and helpful links

General 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.
• Cowan 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.
• Bailey 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID 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