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Breakfast for Obesity

N/A
Waitlist Available
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 month, and 6 month
Awards & highlights

Study Summary

This trial will test whether eating a protein-rich breakfast can help improve weight management and glycemic control in obese adolescents.

Eligible Conditions
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 month, and 6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 month, and 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3-day Average Daily Intake Change
Cravings for Fats Change
Fat Mass Change
+4 more
Secondary outcome measures
Cognitive Function
Cortisol Change
Melatonin Change
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: High Protein (HP) BreakfastExperimental Treatment1 Intervention
The participants in the HP Breakfast group will be provided with HP Breakfasts to consume, at home, between 6:00-9:00 am each day over the 6-month intervention. The energy content of the breakfast meals will be standardized to 350 kcal. The energy content of the breakfast meals is ~18% of daily energy intake estimated from the energy expenditure equations specific for adolescents ages 13-19y. The HP breakfasts will be 34% protein (30g protein), 40% CHO, and 26% fat. The types of protein incorporated within the HP and HP meals will include a combination of animal (egg, dairy, animal tissue) and plant-based proteins (soy, pea, gluten). An 8-d breakfast rotation will occur throughout the 6 months.
Group II: Normal Protein (NP) BreakfastActive Control1 Intervention
The participants in the NP Breakfast group will be provided with NP Breakfasts to consume, at home, between 6:00-9:00 am each day over the 6-month intervention. The energy content of the breakfast meals will be standardized to 350 kcal. The energy content of the breakfast meals is ~18% of daily energy intake estimated from the energy expenditure equations specific for adolescents ages 13-19y. The NP breakfasts will be 11% protein (10g protein), 63% CHO, and 26% fat. The types of protein incorporated within the NP and HP meals will include a combination of animal (egg, dairy, animal tissue) and plant-based proteins (soy, pea, gluten). An 8-d breakfast rotation will occur throughout the 6 months.
Group III: Breakfast Skipping (BS)Placebo Group1 Intervention
The participants in the BS group will continue to skip breakfast each day over the 6-month intervention. They will have nothing to eat or drink (besides water) until 11 am.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Breakfast
2015
Completed Phase 3
~310

Find a Location

Who is running the clinical trial?

University of TennesseeOTHER
189 Previous Clinical Trials
141,926 Total Patients Enrolled
20 Trials studying Obesity
3,676 Patients Enrolled for Obesity
University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
81,141 Total Patients Enrolled
10 Trials studying Obesity
6,090 Patients Enrolled for Obesity
University of Kansas Medical CenterOTHER
464 Previous Clinical Trials
169,172 Total Patients Enrolled
20 Trials studying Obesity
103,612 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Increased Protein at Breakfast for Weight Management in Overweight Adolescents
Heather Leidy 2017. "Increased Protein at Breakfast for Weight Management in Overweight Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03146442.
~13 spots leftby May 2025
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