Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/03/2020
Date assigned
08/04/2020
Last edited
03/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.usariem.army.mil/

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

Publication citations

Additional files

Editorial Notes

03/04/2020: Trial’s existence confirmed by US Department of Defense.