Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/12/2017
Date assigned
10/01/2018
Last edited
10/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Protein intake patterns provide information to inform both policy guidelines and nutrition counseling for various groups in the US population. Dietary protein has gained considerable popularity over the past two decades. Protein has been shown to promote weight loss and maintenance while preserving muscle mass. Furthermore, increased protein intake is associated with lower body weight, BMI and waist circumference, and higher HDL-cholesterol levels. Whether widespread awareness of the advantages of dietary protein and increased availability of protein-containing food products have influenced dietary protein intake trends in the US population is unknown. This study looks at protein intake trends over the past 14 years (2001-2014) and assesses recent (2011-2014) conformance with recommended protein intake according to age, sex, and race and ethnicity in the US population.

Who can participate?
Individuals aged 2+ years, excluding pregnant and lactating women and fasted individuals, are included in the analysis

What does the study involve?
Previously collected data are extracted from the NHANES public database. NHANES is a large ongoing dietary survey of a nationally representative sample of the non-institutionalized US population. Usual protein intakes and trends during 2-year cycles of NHANES 2001–2014 are calculated. Sex, race and ethnicity differences are determined for protein intake and percentage of the population below the recommended protein intake.

What are the possible benefits and risks of participating?
This study will provide data related to protein intake trends over the past 14 years (2001-2014) and recent (2011-2014) conformance with recommended protein intake in the US population according to age, sex, and race/ethnicity, which may allow the identification of groups at risk of low protein intake. There are no risks associated with this study.

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?
January 2001 to December 2014

Who is funding the study?
1. 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 Stefan Pasiakos

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stefan Pasiakos

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R11-01

Study information

Scientific title

Protein intake trends and conformance with the Dietary Reference Intakes in the United States: analysis of the National Health and Nutrition Examination Survey, 2001–2014

Acronym

Study hypothesis

Systematic analysis of dietary protein intake may identify demographic groups within the American population not meeting the Dietary Reference Intakes (DRIs). The objective of this study was to analyze protein intake trends (2001-2014) and evaluate recent conformance to the DRIs (2011-2014) according to age, sex, and race and ethnicity in the US population.

Ethics approval

All participants or proxies provided written informed consent and the Research Ethics Review Board at the National Center for Health Statistics approved the survey protocol.

On 13/10/2010, the USARIEM Human Use Review Committee determined obtaining unidentifiable information does not
constitute human subjects research and, therefore, does not require full human use review for this protocol. Additional
information regarding the National Center for Health Statistics Ethics Review Board Approval for NHANES can be found
here: https://www.cdc.gov/nchs/nhanes/irba98.htm

Study design

Observational epidemiological study

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

Protein intake

Intervention

Data were extracted from a preexisting public database – a nationally representative survey of the US population, NHANES. NHANES is a large ongoing dietary survey of a nationally representative sample of the non-institutionalized US population. The data are collected and released by the National Center for Health Statistics of the Centers for Disease Control and Prevention (National Health and Nutrition Examination Survey; http://cdc.gov/NCHS/nhanes.htm) every 2 years. All data used have previously been collected. The database is accessible to the public (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 were employed, including multiple regression modeling.

Usual protein intakes and trends during 2-year cycles of NHANES 2001–2014 (n=57,980; 2+ y) were calculated as absolute (g/d), relative (g/kg ideal body weight/d) intakes, and as a percentage of total energy. Sex, race and ethnicity (Asian, Hispanic, non-Hispanic Black, and non-Hispanic White) differences were determined for protein intake and percent of the population below the Estimated Average Requirement, Recommended Dietary Allowance, and above and below the Acceptable Macronutrient Distribution Range.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Protein intake trends over the past 14 years (2001-2014) in the U.S. civilian population, extracted from the National Health and Nutrition Examination Survey

Secondary outcome measures

Recent (2011-2014) conformance with protein-specific DRIs according to age, sex, and race and ethnicity in the U.S. civilian population, extracted from the National Health and Nutrition Examination Survey

Overall trial start date

01/01/2001

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

All data to be used have previously been collected and are 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.

Individuals aged 2+ years, excluding pregnant and lactating women and fasted individuals, will be included in the analysis.

Participant type

Healthy volunteer

Age group

All

Gender

Both

Target number of participants

Females and males (n = 57,980, 2+ y) from NHANES 2001-2014 will be included in the analysis

Participant exclusion criteria

1. Less than 2 years old
2. Pregnant or lactating
3. Fasted

Recruitment start date

01/01/2001

Recruitment end date

31/12/2014

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
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, US Army Medical Research and Materiel Command, MRMC, USAMRMC

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 in a publically available repository (National Health and Nutrition Examination Survey; 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