Increased Protein at Breakfast for Weight Management in Overweight Adolescents
1 other identifier
interventional
103
1 country
1
Brief Summary
Adolescent obesity, negatively affecting the lives of over 18 million (34%) US adolescents, continues to be a major public health concern due to the increased risk of developing chronic diseases, including type 2 diabetes. Thus, there is a great need to develop effective, dietary strategies that target health outcomes, including weight management and glycemic control in young people. One particular strategy that is gaining scientific support includes the daily consumption of a protein-rich breakfast. This study will identify the potential role of protein at breakfast as a key component of a healthy diet for improvements in appetite control, satiety, and weight management to reverse the obesity epidemic and prevent and/or delay serious health complications in young people.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
May 7, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedOctober 31, 2023
October 1, 2023
5.7 years
May 7, 2017
October 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Fat Mass Change
Whole body fat mass will be determined with Dual X-ray Absorptiometry (DXA). The DXA uses a linear X-ray fan beam with switched-pulse dual-energy and a multi-element detector array. The whole body scan takes \<1.8 sec with radiation exposure of 0.01mGy.
Baseline, 3 month, and 6 month
3-day Average Daily Intake Change
Free-living daily energy intake will be assessed for 3 consecutive days through daily food packouts. The participants will be provided with an excess of macronutrient-specific meals, snacks, and beverages to consume, ad libitum, throughout each day in addition to the required, respective breakfast treatment. The quantity of food provided will be \~50% more than their estimated, weight-maintaining energy intake. All food items will be initially weighed and recorded. The participants will be instructed to return all uneaten foods as well as all wrappers and containers from consumed food. Any partially eaten, returned items will be weighed accordingly. Daily energy content will be assessed from these packouts.
Baseline, 3 month, and 6 month
Glucose Excursions Change
Free-living, glucose measures will be performed for 6 consecutive days using Continuous Glucose Monitoring Device. The participants will report to our facility during one afternoon for insertion. A small area on the participant's abdomen will be cleaned and the tiny glucose sensor will be inserted just under the skin and held in place with Tegederm. The sensor measures glucose every 10sec and records an average glucose value every 5min for up to 144h.Calibration is performed by 4 finger sticks/d with a glucose analyzer.
Baseline, 3 month, and 6 month
PYY Change
During a single clinical visit, 22 blood samples (4 ml/sample) will be collected throughout a 10-h period. The samples will be collected in EDTA test tubes containing pefabloc SC and DPP-IV to reduce protein degradation. Within 10-min of collection, the samples will be centrifuged, and the plasma will be stored at -80°C for future analysis. Plasma total PYY will be measured using magnetic bead-based multi-analyte assays (Millipore, St.Charles, MO) \& Luminex technologies (Luminex Corporation, Austin, TX).
Baseline, 3 month, and 6 month
Fullness Change
During a single clinical visit, 22 questionnaires, assessing feelings of 'fullness' will be collected over a 10-h period. The questionnaires contain VAS incorporating a 100mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The Adaptive Visual Analog Scale Software will be used for data collection (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX).
Baseline, 3 month, and 6 month
Cravings for Fats Change
During a single clinical visit, 22 questionnaires, assessing cravings for fat foods will be collected over a 10-h period. The questionnaires contain VAS incorporating a 100mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The Adaptive Visual Analog Scale Software will be used for data collection (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX).
Baseline, 3 month, and 6 month
fMRI Anterior Cingulate Neural Response Change
During a single clinical visit, the participants will arrive at the testing facilities 1-h prior to breakfast, following a 10-h overnight fast. The participants will be taken to a self-contained, comfortable, quiet room. At +0 min, the participants will consume the respective breakfast (or continue to skip breakfast). Immediately after breakfast, the participants will complete a food cue-stimulated fMRI brain scan. After the completion of the scan participants will complete the remaining testing procedures. At approximately 4-h after breakfast the participants will be provided with a standardized lunch and then continue with testing procedures. 3.5-h following lunch, participants will complete a final fMRI brain scan.
Baseline, 3 month, and 6 month
Secondary Outcomes (5)
Sleep Health
Baseline, 3 month, and 6 month
Cognitive Function
Baseline, 3 month, and 6 month
Structural MRI Change
Baseline and 6 month
Cortisol Change
Baseline, 3 month, and 6 month
Melatonin Change
Baseline, 3 month, and 6 month
Study Arms (3)
Normal Protein (NP) Breakfast
ACTIVE COMPARATORThe 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.
High Protein (HP) Breakfast
EXPERIMENTALThe 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.
Breakfast Skipping (BS)
PLACEBO COMPARATORThe 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.
Interventions
For 6 months, the participants will either skip breakfast or will habitually consume a NP or HP breakfast every day.
Eligibility Criteria
You may qualify if:
- All ethnicities
- BMI: 25-34kg/m2 or 85th-98th percentile
- Skips Breakfast (\<110 kcal prior to 10 am) at least 4 days/week for the past year
- Never smoked or used other tobacco products
- Willing to consume the study breakfasts
- Generally healthy
You may not qualify if:
- Clinically diagnosed with an eating disorder
- Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
- Currently or previously on a weight loss or other special diet (in the past 6 months)
- Gained/lost ≥4.5kg over the past 6 months
- Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months)
- Normal cognitive restraint (assessed from the Three Factor Eating Habits Questionnaire)
- Does not consistently eat lunch and/or dinner every day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas at Austinlead
- University of Kansas Medical Centercollaborator
- University of Tennesseecollaborator
Study Sites (1)
University of Texas at Austin
Austin, Texas, 78723, United States
Related Publications (1)
Piacquadio KA, Margolis LM, Gwin JA, Leidy HJ. Preliminary Evidence Supports that Long-Term Consumption of Higher-Protein Breakfast Promotes Higher Expression of Select miRNA Associated with Cardiometabolic Health in Adolescents. J Nutr. 2024 Dec;154(12):3585-3591. doi: 10.1016/j.tjnut.2024.10.007. Epub 2024 Oct 10.
PMID: 39393494DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind, the PI and outcomes assessor will be blinded to the intervention arms (which will be designated with code words). The participants in the high protein and normal protein intervention arms will be blinded to the protein content within the breakfast meals (which will be designated with code words).
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 7, 2017
First Posted
May 10, 2017
Study Start
August 1, 2017
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
October 31, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share