Breakfast and Metabolism in Men
The Effect of Breakfast on Energy Metabolism, Appetite, and Food Intake in Men
1 other identifier
interventional
33
1 country
1
Brief Summary
This study will determine the short-term postprandial effects of protein source at breakfast on energy metabolism, markers of metabolic health, appetite, and food intake and young and older men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2017
CompletedFirst Submitted
Initial submission to the registry
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
January 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedJuly 17, 2018
July 1, 2018
5 months
January 8, 2018
July 15, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Energy expenditure
Energy expended per minute will be measured using indirect calorimetry.
Time frame is every 30 minutes for four hours following intervention.
Appetite
Appetite will be assessed using a traditional 100-mm visual analog scale (VAS) (3) with opposing anchors (e.g., "extremely hungry" or "not hungry at all") at time points 15, 30, 60, 90, 120, 180 and 240 min. Questions consisted of: "how hungry do you feel at this moment", "how full do you feel at this moment", "how strong is your desire to eat this moment" and "how much food do you think you can eat at this moment." Participants were asked to place an "X" on the 100-mm VAS in the place that pertained to their perceived appetite feelings at each time point." Participants were asked to place an "X" on the 100-mm VAS in the place that pertained to their perceived appetite feelings at each time point. The averages for each time point are taken to represent the feeling of appetitive at a particular time point.
Time frame is every 30 minutes for four hours following intervention.
Secondary Outcomes (1)
24-hour food intake
Food intake will be recorded for one day.
Other Outcomes (1)
Appetite biomarkers
Time frame is every 30 minutes for four hours following intervention.
Study Arms (2)
Whey protein isolate
EXPERIMENTALPea protein isolate
ACTIVE COMPARATORInterventions
The animal protein intervention is a smoothie containing 40 grams of whey protein isolate.
The animal protein intervention is a smoothie containing 40 grams of pea protein isolate.
Eligibility Criteria
You may qualify if:
- Male
- No medication
- Athlete (elite or professional)
You may not qualify if:
- Diet-related conditions
- Food allergies
- Does not regularly consume protein supplements
- Claustrophobic
- Underweight
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas
Fayetteville, Arkansas, 72704, United States
Related Publications (1)
Hawley AL, Gbur E, Tacinelli AM, Walker S, Murphy A, Burgess R, Baum JI. The Short-Term Effect of Whey Compared with Pea Protein on Appetite, Food Intake, and Energy Expenditure in Young and Older Men. Curr Dev Nutr. 2020 Jan 22;4(2):nzaa009. doi: 10.1093/cdn/nzaa009. eCollection 2020 Feb.
PMID: 32072131DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie Baum
University of Arkansas, Fayetteville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 8, 2018
First Posted
January 16, 2018
Study Start
December 15, 2017
Primary Completion
April 30, 2018
Study Completion
June 30, 2018
Last Updated
July 17, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share