A retrospective study of demographic and lifestyle factors associated with caffeine and dietary supplement use

ISRCTN	ISRCTN15296828
DOI	https://doi.org/10.1186/ISRCTN15296828
Secondary identifying numbers	R11-01

Submission date: 11/10/2017
Registration date: 20/10/2017
Last edited: 21/11/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
The relationships between consumption of caffeine or dietary supplements (DS) and health outcomes are controversial. Some studies have associated caffeine intake with negative outcomes such as caffeine dependence and cardiovascular (heart) disease. Other studies have linked caffeine intake with favorable outcomes, such as a reduced risk for Parkinson’s disease and beneficial effects on cognitive performance and mood state. Similarly, there is evidence to suggest that particular DS may improve aspects of health and well-being, such as sleep, exercise performance, and bone density. However, consumption of certain DS – particularly those sold for weight loss – has been associated with adverse outcomes, including renal (kidney) failure, myocardial infarction (heart attack) and stroke in military and civilian populations. Potential associations between caffeine or DS usage and health and performance outcomes have public health relevance for military as well as civilian populations. Current data on the characteristics, usage patterns and adverse effects of caffeine and DS on the general US population are not available. The aim of this study is to investigate relationships between caffeine and DS intake and various demographic and lifestyle variables in a representative sample of the US population using a nationally-representative, publicly-available database – the National Health and Nutrition Examination Survey (NHANES). A survey of Army-wide caffeine and DS use is being conducted by the US Army Research Institute of Environmental Medicine. It is essential to have civilian data for comparison and interpretation of Army data.

Who can participate?
Data is extracted from a pre-existing public database – a nationally representative survey of the US population, the National Health and Nutrition Examination Survey (NHANES)

What does the study involve?
Information on the relationship between caffeine and DS intake and various demographic and lifestyle data and adverse outcomes is extracted from the NHANES. The results of this study are compared to previously published survey-based research and to survey data published in the future. The populations studied are selected so that the results can be compared to military populations.

What are the possible benefits and risks of participating?
This study will provide data on the extent and patterns of use of caffeine and DS and possible adverse effects in the civilian population, providing information relevant to the Army and other DoD services including possible risks and benefits of DS or caffeine intake. This information will also provide reference population data for interpreting findings on caffeine and DS use by military personnel.

Where is the study run from?
US Army Research Institute of Environmental Medicine (USA)

When is the study starting and how long is it expected to run for?
October 2010 to December 2016

Who is funding the study?
1. US Army Medical Research and Materiel Command (USA)
2. Department of Defense Center Alliance for Nutrition and Dietary Supplement Research (USA)

Who is the main contact?
Dr Harris Lieberman

Contact information

Dr Harris Lieberman
Public

10 General Greene Avenue, Building 42
Natick, MA
01760
United States of America

Study information

Study design	Epidemiological retrospective investigation
Primary study design	Observational
Secondary study design	Epidemiological study
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A retrospective study of demographic and lifestyle factors associated with caffeine and dietary supplement use
Study hypothesis	Current data on the characteristics, usage patterns and adverse effects of caffeine and dietary supplements (DS) on the general US population are not available. This study will provide data on the extent and patterns of use of caffeine and DS and possible adverse effects in the civilian population, providing information relevant to the Army and other DoD services including possible risks and benefits of DS or caffeine intake. This information also will provide reference population data for interpreting findings on caffeine and DS use by military personnel.
Ethics approval(s)	The US Army Research Institute of Environmental Medicine (USARIEM) Scientific Review Board approved the research plan on 13/10/2010; the USARIEM Human Use Review Committee determined obtaining unidentifiable information did not constitute human subjects research and therefore did not require full human use review on 13/10/2010; final approval to implement the research protocol was granted by the USARIEM Commander on 13/10/2010.
Condition	Caffeine and dietary supplement intake and various demographic and lifestyle data and adverse outcomes
Intervention	Data will be extracted from a preexisting public database – a nationally representative survey of the US population, the National Health and Nutrition Examination Survey (NHANES) – to obtain information on the relationship between caffeine and DS intake and various demographic and lifestyle data and adverse outcomes. All data to be used have previously been collected. The database is accessible to the public through the Centers for Disease Control website on the World Wide Web (National Health and Nutrition Examination Survey; http://cdc.gov/NCHS/nhanes.htm) and does not contain any personal identifiers. Standard statistical methods for analysis of weighted population NHANES datasets will be employed, including multiple regression modeling.
Intervention type	Other
Primary outcome measure	The extent and patterns of use of caffeine and DS and possible adverse effects in the civilian population, extracted from the National Health and Nutrition Examination Survey
Secondary outcome measures	Reference population data for interpreting findings on caffeine and DS use by military personnel, extracted from the National Health and Nutrition Examination Survey
Overall study start date	01/10/2010
Overall study end date	31/12/2016

Eligibility

Participant type(s)	All
Age group	Adult
Sex	Both
Target number of participants	This is an epidemiological retrospective investigation. Data will be extracted from a pre-existing public database – a nationally representative survey of the US population.
Participant inclusion criteria	All data to be used have previously been collected and is part of an existing national public database (NHANES) accessible to the public through the Centers for Disease Control website on the World Wide Web (National Health and Nutrition Examination Survey; http://cdc.gov/NCHS/nhanes.htm). This data does not contain any personal identifiers.
Participant exclusion criteria	This is an epidemiological retrospective investigation. Data will be extracted from a preexisting public database – a nationally representative survey of the US population.
Recruitment start date	13/10/2010
Recruitment end date	31/12/2016

Locations

Countries of recruitment

United States of America

Study participating centre

US Army Research Institute of Environmental Medicine

Natick
01760
United States of America

Sponsor information

US Army Research Institute of Environmental Medicine
Government

10 General Greene Avenue, building 42
Natick, MA
01760
United States of America

"ROR"	https://ror.org/00rg6zq05

Funders

Funder type

Government

Medical Research and Materiel Command
Government organisation / National government

Alternative name(s): U.S. Army Medical Research and Materiel Command, US Army Medical Research and Materiel Command, MRMC, USAMRMC
Location: United States of America

Department of Defense Center Alliance for Nutrition and Dietary Supplement Research

No information available

Results and Publications

Intention to publish date	01/07/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	The results of this study should be published in a high-visibility peer-reviewed nutrition journal by mid-2018.
IPD sharing plan	De-identified data are available at the participant level for all study participants. These data can be found at: http://cdc.gov/NCHS/nhanes.htm.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	daily pattern of caffeine intake and demographics	01/01/2019	15/01/2019	Yes	No
Results article	Shift workers	12/03/2020	21/11/2023	Yes	No

Editorial Notes

21/11/2023: Publication reference added.
15/01/2019: Publication reference added.