NCT03083145

Brief Summary

The objective of this study is to determine how the protein source and the physical form of food consumed at breakfast impact food intake. Research will be conducted by assessing feelings of hunger, food preference and blood glucose in healthy adults following the ingestion protein-based (animal versus plant) drinks similar calorie and protein content.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2016

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

March 9, 2017

Last Update Submit

March 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Appetite assessment

    Appetite was assessed using visual analog scales

    2 hours

Secondary Outcomes (1)

  • Snack intake using checklist

    1 hour

Study Arms (2)

Educational Messaging

ACTIVE COMPARATOR

Whey protein beverage and pea protein beverages administered in a randomized order with a one- to two-week washout period between beverages.

Dietary Supplement: Whey Protein BeverageDietary Supplement: Pea Protein BeverageBehavioral: Snack Tray Choices

No Messaging

ACTIVE COMPARATOR

Whey protein beverage and pea protein beverages administered in a randomized order with a one- to two-week washout period between beverages.

Dietary Supplement: Whey Protein BeverageDietary Supplement: Pea Protein BeverageBehavioral: Snack Tray Choices

Interventions

Whey Protein BeverageDIETARY_SUPPLEMENT

Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.

Educational MessagingNo Messaging
Pea Protein BeverageDIETARY_SUPPLEMENT

Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.

Educational MessagingNo Messaging

Items were selected from a snack tray filled with healthy and unhealthy snacks in order to determine if educational messaging influenced snack choices. Shack choices wre recorded on a check list by a third party observer.

Educational MessagingNo Messaging

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, no known health conditions

You may not qualify if:

  • Taking medication, excluding hormonal birth control
  • Food allergies
  • Food intolerances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 17, 2017

Study Start

February 1, 2016

Primary Completion

May 15, 2016

Study Completion

June 1, 2016

Last Updated

March 17, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations