NCT03399812

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

January 8, 2018

Last Update Submit

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

EXPERIMENTAL
Dietary Supplement: Animal protein

Pea protein isolate

ACTIVE COMPARATOR
Dietary Supplement: Plant protein

Interventions

Animal proteinDIETARY_SUPPLEMENT

The animal protein intervention is a smoothie containing 40 grams of whey protein isolate.

Whey protein isolate
Plant proteinDIETARY_SUPPLEMENT

The animal protein intervention is a smoothie containing 40 grams of pea protein isolate.

Pea protein isolate

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Interventions

Plant Proteins

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Jamie Baum

    University of Arkansas, Fayetteville

    PRINCIPAL INVESTIGATOR

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

Locations