Plain English Summary
Background and study aims
Greater protein intakes are associated with lower body weight, body mass index, waist circumference and increased HDL-cholesterol concentrations. However, the relationship between protein intake during specific eating occasions and cardio metabolic health is not well described. This study measured protein intake at meals (breakfast, lunch, dinner) and combined snacking occasions and evaluated associations between protein intake at meals or snacking occasions and markers of cardio metabolic health in US adults.
The purpose of this study was to characterize dietary protein intake at meal (breakfast, lunch, or dinner) and combined snacking occasions, evaluate the associations between protein intake at specific eating occasions and markers of cardio metabolic health, and estimate protein intakes at specific eating occasions that benefit cardio metabolic health in U.S. adults.
Who can participate?
Data will be provided by the National Health and Nutrition Examination Survey (NHANES) database.
What does the study involve?
Data were extracted from a pre-existing 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.
What are the possible benefits and risks of participating?
None
Where is the study run from?
US Army Research Institute of Environmental Medicine
When is the study starting and how long is it expected to run for?
January 2013 to December 2014
Who is funding the study?
1. United States Army Medical Research and Development Command
2. Department of Defense Center Alliance for Nutrition and Dietary Supplement Research (USA)
Who is the main contact?
Dr Claire Berryman
cberryman@fsu.edu
Dr Stefan Pasiakos
stefan.m.pasiakos.civ@mail.mil
Trial website
Contact information
Type
Scientific
Primary contact
Dr Claire Berryman
ORCID ID
http://orcid.org/0000-0002-7841-8226
Contact details
436 Sandels Building
Florida State University
Tallahassee
32306
United States of America
+1 304-216-1050
cberryman@fsu.edu
Type
Scientific
Additional contact
Dr Stefan Pasiakos
ORCID ID
http://orcid.org/0000-0002-5378-5820
Contact details
10 General Greene Avenue
Building 42
Natick
01760
United States of America
+1 508-202-8624
stefan.m.pasiakos.civ@mail.mil
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
R11-01
Study information
Scientific title
Relationship between protein intake at specific meal and snacking occasions and cardiometabolic health outcomes in US adults
Acronym
Study hypothesis
Is the amount of dietary protein consumed at a specific eating occasion associated with markers of cardiometabolic health and the optimal protein quantity needed during those eating occasions to improve health?
The purpose of this study was to characterize dietary protein intake at meal (breakfast, lunch, or dinner) and combined snacking occasions, evaluate the associations between protein intake at specific eating occasions and markers of cardiometabolic health, and estimate protein intakes at specific eating occasions that benefit cardiometabolic health in U.S. adults.
Ethics approval
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
Cross-sectional epidemiological
Primary study design
Observational
Secondary study design
Epidemiological study
Trial setting
Other
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Protein intake at meal and snack occasions
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.
Deciles of individual usual intake (IUI) for protein at meals and combined snacking occasions were calculated using NHANES 2013-2016 data (n=10,112; ≥ 19 y). Regression analysis was used to determine decile and linear trends for cardiometabolic risk factors by IUI for protein at specific meals (breakfast, lunch, or dinner) and combined snacking occasions. Both models 1 and 2 included age, age*2, sex, race or ethnicity (Hispanic, white, black, Asian, other), physical activity level, poverty income ratio, and protein IUI at other eating occasions throughout the day as model covariates. Model 1 also included total energy IUI at the eating occasion being analyzed as an additional covariate. Model 2 also included carbohydrate and fat IUI at the eating occasion being analyzed and BMI (non-weight-related variables) as additional covariates. Cardiometabolic variables were regressed by decile of IUI protein intake greater than or equal to a given decile to help determine amounts of protein associated with changes in cardiometabolic factors. The regressions were done one protein intake decile at a time. For example, decile 1 is compared to all others, then deciles 1 and 2 with all others, and so on. Independent t-tests were used to evaluate differences between decile groups. Data are interpreted with Bonferroni-corrected P < 0.0042 (0.05/12 variables) considered significant.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Data extracted from the National Health and Nutrition Examination Survey (2013-2016):
1. Protein intake at specific eating occasions
2. Markers of cardiometabolic health:
2.1 Body mass index kg/m²
2.2 Waist circumference (cm)
2.3 Systolic and diastolic blood pressure (mmHg)
2.4 Fasting triglycerides
2.5 Total cholesterol
2.6 LDL-cholesterol
2.7 HDL-cholesterol
2.8 Glucose and insulin concentrations
2.9 Homeostatic model assessment of insulin resistance (HOMA-IR)
2.10 Cardiovascular disease (CVD) risk score
Secondary outcome measures
None
Overall trial start date
08/11/2018
Overall trial end date
08/11/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All data 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).
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
10,112
Participant exclusion criteria
1. Less than 20 years old
2. Pregnant or lactating
3. Fasted
Recruitment start date
01/01/2013
Recruitment end date
31/12/2016
Locations
Countries of recruitment
United States of America
Trial participating centre
US Army Research Institute of Environmental Medicine
10 General Greene Avenue
Building 42
Natick
01760
United States of America
Sponsor information
Organisation
US Army Research Institute of Environmental Medicine
Sponsor details
10 General Greene Avenue
Building 42
Natick
01760
United States of America
+1 508-202-8624
stefan.m.pasiakos.civ@mail.mil
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
United States Army Medical Research and Development Command
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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 will be published in a peer-reviewed nutrition journal.
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
01/04/2020
Participant level data
Stored in repository
Basic results (scientific)
Publication list