NCT02272153

Brief Summary

The satiety effects of the combination of protein and fiber within egg and whole grain breakfast meals. High protein with low and high-fiber is hypothesized to be more satiating than low protein, low fiber.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

October 20, 2014

Last Update Submit

January 14, 2015

Conditions

Food Selection

Outcome Measures

Primary Outcomes (1)

  • Satiety

    Measure satiety by visual analog scales (VAS)

    210 minutes

Secondary Outcomes (2)

  • Food intake

    210 minutes

  • Blood glucose response

    180 minutes

Study Arms (3)

Egg refined grain

ACTIVE COMPARATOR

Eggs with white toast

Other: Egg refined grainOther: Egg Whole GrainOther: Cereal Refined grain

Egg whole grain

ACTIVE COMPARATOR

Eggs with whole grain toast

Other: Egg refined grainOther: Egg Whole GrainOther: Cereal Refined grain

Cereal Refined grain

ACTIVE COMPARATOR

rice cereal with white toast

Other: Egg refined grainOther: Egg Whole GrainOther: Cereal Refined grain

Interventions

Egg refined grainOTHER
Cereal Refined grainEgg refined grainEgg whole grain
Egg Whole GrainOTHER
Cereal Refined grainEgg refined grainEgg whole grain
Cereal Refined grainOTHER
Cereal Refined grainEgg refined grainEgg whole grain

Eligibility Criteria

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

You may qualify if:

  • healthy,
  • non-smoking,
  • BMI of 18-27,
  • non-dieting,
  • typically consumes breakfast/lunch

You may not qualify if:

  • distaste for eggs,
  • vegetarian,
  • current smoker,
  • restrained eating habits,
  • recent weight change,
  • history of significant disease of past medical history,
  • pregnant,
  • lactating irregular menstrual cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Science and Nutrition

Saint Paul, Minnesota, 55108, United States

Location

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Joanne L Slavin, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 22, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations

US(1)