Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/10/2017
Date assigned
20/10/2017
Last edited
20/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Dr Harris Lieberman

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R11-01

Study information

Scientific title

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

Acronym

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

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.

Study design

Epidemiological retrospective investigation

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/10/2010

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

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 type

All

Age group

Adult

Gender

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 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

Trial participating centre

US Army Research Institute of Environmental Medicine
01760

Sponsor information

Organisation

US Army Research Institute of Environmental Medicine

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Medical Research and Materiel Command

Alternative name(s)

U.S. Army Medical Research and Materiel Command, USAMRMC, MRMC

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Department of Defense Center Alliance for Nutrition and Dietary Supplement Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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.

Intention to publish date

01/07/2018

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes