Breakfast and Metabolism in Men

The Effect of Breakfast on Energy Metabolism, Appetite, and Food Intake in Men

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Animal protein; Dietary supplement: Plant protein

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • University of Arkansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male
• No medication
• Athlete (elite or professional)

Exclusion Criteria:

• Diet-related conditions
• Food allergies
• Does not regularly consume protein supplements
• Claustrophobic
• Underweight

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whey protein isolate	Dietary supplement: Animal protein; The animal protein intervention is a smoothie containing 40 grams of whey protein isolate.
Active Comparator: Pea protein isolate	Dietary supplement: Plant protein; The animal protein intervention is a smoothie containing 40 grams of pea protein isolate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour food intake	Food intake following the intervention will be recorded using food records.	Food intake will be recorded for one day.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite biomarkers	PYY, CCK and orexin will be measured.	Time frame is every 30 minutes for four hours following intervention.

Collaborators and Investigators

• Sponsor: University of Arkansas, Fayetteville
• Investigators: Principal Investigator: Jamie Baum, University of Arkansas, Fayetteville

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 15, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1708038914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No