Protein intake at meal and snack occasions

ISRCTN	ISRCTN11120152
DOI	https://doi.org/10.1186/ISRCTN11120152
Secondary identifying numbers	R11-01

Submission date: 11/03/2020
Registration date: 08/04/2020
Last edited: 28/10/2022

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 of protocol

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

Contact information

Dr Claire Berryman
Scientific

436 Sandels Building
Florida State University
Tallahassee
32306
United States of America

ORCID ID	0000-0002-7841-8226
Phone	+1 304-216-1050
Email	cberryman@fsu.edu

Dr Stefan Pasiakos
Scientific

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

ORCID ID	0000-0002-5378-5820
Phone	+1 508-202-8624
Email	stefan.m.pasiakos.civ@mail.mil

Study information

Study design	Cross-sectional epidemiological
Primary study design	Observational
Secondary study design	Epidemiological study
Study setting(s)	Other
Study type	Other
Participant information sheet	No participant information sheet available
Scientific title	Relationship between protein intake at specific meal and snacking occasions and cardiometabolic health outcomes in US adults
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	08/11/2018
Completion date	08/11/2019

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	10,112
Total final enrolment	10112
Key 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).
Key exclusion criteria	1. Less than 20 years old 2. Pregnant or lactating 3. Fasted
Date of first enrolment	01/01/2013
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

United States of America

Study participating centre

US Army Research Institute of Environmental Medicine

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

Sponsor information

US Army Research Institute of Environmental Medicine
Government

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

Phone	+1 508-202-8624
Email	stefan.m.pasiakos.civ@mail.mil
Website	http://www.usariem.army.mil/
"ROR"	https://ror.org/00rg6zq05

Funders

Funder type

Government

United States Army Medical Research and Development Command

No information available

Department of Defense Center Alliance for Nutrition and Dietary Supplement Research

No information available

Results and Publications

Intention to publish date	01/04/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
Publication and dissemination plan	The results of this study will be published in a peer-reviewed nutrition journal.
IPD sharing plan	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).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		23/01/2021	28/10/2022	Yes	No

Editorial Notes

28/10/2022: Publication reference and total final enrolment added.
03/04/2020: Trial’s existence confirmed by US Department of Defense.