Obesity, AdolescentNCT03146442
Increased Protein at Breakfast for Weight Management in Overweight Adolescents
A study testing Breakfast in people with Obesity, Adolescent, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent
- What is being tested?
- Breakfast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Adolescent obesity continues to be a major public health concern due to the increased risk of developing chronic diseases, including, but not limited to, type 2 diabetes. Thus, strategies are vitally needed that target weight management and glycemic control to reverse the obesity epidemic and prevent and/or delay serious health complications in young people. The daily consumption of breakfast has been touted as an essential part of the diet to prevent and/or treat obesity. While breakfast was once thought to be 'the most important meal of the day', this notion has recently been challenged due to the paucity of existing causal evidence. In addition, interest in the study of breakfast and weight management has highlighted the importance of macronutrient content, particularly increased dietary protein at breakfast, as a critical factor. Pilot data has illustrated reductions in body fat mass and improvements in glycemic control following the daily consumption of high protein breakfasts over a short period in overweight adolescents. However, it is unclear as to whether these effects would occur over the long-term and what mechanisms-of-action contribute to the improvements in these health outcomes. Aim 1 will determine whether a causal link exists between breakfast, particularly one rich in dietary protein, and weight management in young people. To accomplish this, 150 overweight, habitual breakfast-skipping adolescents will complete the following long-term randomized, tightly-controlled breakfast trial. Participants will be randomly provided with high protein breakfasts (350kcal; 34% protein (30g protein), 40% CHO, and 26% fat); isocaloric normal protein breakfasts (350kcal; 11% protein (10g protein), 63% CHO, and 26% fat); or will continue to skip breakfast for 6 mo. Baseline, 3, and 6 body weight, body composition, and free-living glycemic control will be assessed. In addition, daily intake, with particular focus on evening snacking behavior, will also be measured at baseline, 3, and 6 mo. Aim 2 will identify the appetitive, hormonal, and neural signals by which a protein breakfast modulates ingestive (i.e., eating) behavior and weight management. To address this aim, a sub-set of the 150 (n=75) will complete 10-h testing days during baseline, 3, and 6 mo. Repeated assessments of perceived appetite, satiety, and food cravings along with appetite-regulating hormonal responses (i.e., plasma ghrelin, GLP-1, PYY, and HVA (the primary dopamine metabolite)) will be measured throughout the day. In addition, post-breakfast and pre-dinner functional (fMRI) brain scans will also be completed to identify neural activation to food stimuli in cortico-limbic brain regions known to modulate food motivation, reward, and cravings along with structural scans. Aim 3 will identify specific appetitive, hormonal, and neural signals as strong predictors of ingestive behavior and weight management. Within this sub-set of 150, aim 4 will determine whether a causal link exists between breakfast, particularly one rich in dietary protein, and cognitive performance (memory, attention, and executive function). These assessments will also be paired with structural scans. The measures collected in Aim 2 will be analyzed in combination with food choice, daily intake, weight loss, and reductions in body fat following the 6-mo interventions. Collectively, this project will provide novel evidence testing the consumption of a high protein breakfast as a dietary strategy to combat obesity in young people.
- Conditions
- Obesity, Adolescent
- Being tested
- Breakfast
- Keywords
- increased dietary protein, breakfast, weight management, satiety, glucose control, fMRI, cognitive performance, memory, attention, executive function, structural MRI, sleep quality
- Medical subject headings
- Pediatric Obesity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreakfastBehavioural
For 6 months, the participants will either skip breakfast or will habitually consume a NP or HP breakfast every day.
| Study group | Role | What they receive |
|---|---|---|
| Normal Protein (NP) Breakfast | Active comparator | 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. Receives: Behavioral: Breakfast |
| High Protein (HP) Breakfast | Experimental | 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. Receives: Behavioral: Breakfast |
| Breakfast Skipping (BS) | Placebo comparator | 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. Receives: Behavioral: Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline, 3 month, and 6 month
Secondary outcomes (5)
Sleep Health
Free-living sleep will be measured for 7 days through actigraphy. The device will be worn on the wrist for 7 days and the participant will continuously wear it over the next 7 days for an overall measurement of sleep quality. Sleep quality and daytime sleepiness will also be assessed using sleep diaries and questionnaires.
Measured: Baseline, 3 month, and 6 month
Cognitive Function
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. 30 minutes prior to breakfast, participants will begin a series of cognitive tests assessing memory, attention, and executive function. At +0 min, the participants will consume the respective breakfast (or continue to skip breakfast). At +90 and +150 min, participants will complete the same series of cognitive tests assessing memory, attention, and executive function.
Measured: Baseline, 3 month, and 6 month
Structural MRI 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). After breakfast, the participants will complete a brain scan that includes structural analysis.
Measured: Baseline and 6 month
Cortisol Change
Salivary samples will be collected prior to sleep onset and upon waking at various times throughout baseline, 3-month, and 6-month testing periods. The samples will be collected in mini cryo-tubes and stored at -80°C for future analysis. Salivary cortisol will be measured using a competitive immunoassay designed and validated for the quantitative determination of melatonin in saliva (Salimetrics, State College, PA).
Measured: Baseline, 3 month, and 6 month
Melatonin Change
Salivary samples will be collected prior to sleep onset and upon waking at various times throughout baseline, 3-month, and 6-month testing periods. The samples will be collected in mini cryo-tubes and stored at -80°C for future analysis. Salivary melatonin will be measured using a competitive immunoassay designed and validated for the quantitative determination of melatonin in saliva (Salimetrics, State College, PA).
Measured: Baseline, 3 month, and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Aug 2017
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants will be randomly assigned to the following breakfast groups: high protein breakfast (350kcal; 34% protein (30g protein), 40% CHO, and 26% fat); normal protein breakfast (350kcal; 11% protein (10g protein), 63% CHO, and 26% fat); or breakfast skipping (0 kcal)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center, University of Tennessee
- Responsible party
- Principal investigator, Heather Leidy, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146442
- Sponsor's protocol ID
- 1611018490
- Status last verified
- Oct 2023
- First submitted
- 7 May 2017
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39393494
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Protein at Breakfast for Weight Management in Overweight Adolescents
- ClinicalTrials.gov ID
- NCT03146442
- Acronym / sponsor ID
- 1611018490
- Conditions
- Obesity, Adolescent
- Keywords
- increased dietary protein, breakfast, weight management, satiety, glucose control, fMRI, cognitive performance, memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center, University of Tennessee
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adolescent obesity continues to be a major public health concern due to the increased risk of developing chronic diseases, including, but not limited to, type 2 diabetes. Thus, strategies are vitally needed that target weight management and glycemic control to reverse the obesity epidemic and prevent and/or delay serious health complications in young people. The daily consumption of breakfast has been touted as an essential part of the diet to prevent and/or treat obesity. While breakfast was once thought to be 'the most important meal of the day', this notion has recently been challenged due to the paucity of existing causal evidence. In addition, interest in the study of breakfast and weight management has highlighted the importance of macronutrient content, particularly increased dietary protein at breakfast, as a critical factor. Pilot data has illustrated reductions in body fat mass and improvements in glycemic control following the daily consumption of high protein breakfasts over a short period in overweight adolescents. However, it is unclear as to whether these effects would occur over the long-term and what mechanisms-of-action contribute to the improvements in these health outcomes. Aim 1 will determine whether a causal link exists between breakfast, particularly one rich in dietary protein, and weight management in young people. To accomplish this, 150 overweight, habitual breakfast-skipping adolescents will complete the following long-term randomized, tightly-controlled breakfast trial. Participants will be randomly provided with high protein breakfasts (350kcal; 34% protein (30g protein), 40% CHO, and 26% fat); isocaloric normal protein breakfasts (350kcal; 11% protein (10g protein), 63% CHO, and 26% fat); or will continue to skip breakfast for 6 mo. Baseline, 3, and 6 body weight, body composition, and free-living glycemic control will be assessed. In addition, daily intake, with particular focus on evening snacking behavior, will also be measured at baseline, 3, and 6 mo. Aim 2 will identify the appetitive, hormonal, and neural signals by which a protein breakfast modulates ingestive (i.e., eating) behavior and weight management. To address this aim, a sub-set of the 150 (n=75) will complete 10-h testing days during baseline, 3, and 6 mo. Repeated assessments of perceived appetite, satiety, and food cravings along with appetite-regulating hormonal responses (i.e., plasma ghrelin, GLP-1, PYY, and HVA (the primary dopamine metabolite)) will be measured throughout the day. In addition, post-breakfast and pre-dinner functional (fMRI) brain scans will also be completed to identify neural activation to food stimuli in cortico-limbic brain regions known to modulate food motivation, reward, and cravings along with structural scans. Aim 3 will identify specific appetitive, hormonal, and neural signals as strong predictors of ingestive behavior and weight management. Within this sub-set of 150, aim 4 will determine whether a causal link exists between breakfast, particularly one rich in dietary protein, and cognitive performance (memory, attention, and executive function). These assessments will also be paired with structural scans. The measures collected in Aim 2 will be analyzed in combination with food choice, daily intake, weight loss, and reductions in body fat following the 6-mo interventions. Collectively, this project will provide novel evidence testing the consumption of a high protein breakfast as a dietary strategy to combat obesity in young people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to the following breakfast groups: high protein breakfast (350kcal; 34% protein (30g protein), 40% CHO, and 26% fat); normal protein breakfast (350kcal; 11% protein (10g protein), 63% CHO, and 26% fat); or breakfast skipping (0 kcal)
| Arm | Type | Receives |
|---|---|---|
| Normal Protein (NP) Breakfast | Active comparator | Behavioral: BreakfastThe 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 | Experimental | Behavioral: BreakfastThe 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 comparator | Behavioral: BreakfastThe 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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreakfastFor 6 months, the participants will either skip breakfast or will habitually consume a NP or HP breakfast every day. | Behavioural | Breakfast Skipping (BS), High Protein (HP) Breakfast, Normal Protein (NP) Breakfast |
Primary outcome
Fat Mass Change
Time frame: Baseline, 3 month, and 6 month
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.
3-day Average Daily Intake Change
Time frame: Baseline, 3 month, and 6 month
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.
Glucose Excursions Change
Time frame: Baseline, 3 month, and 6 month
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.
PYY Change
Time frame: Baseline, 3 month, and 6 month
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).
Fullness Change
Time frame: Baseline, 3 month, and 6 month
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).
Cravings for Fats Change
Time frame: Baseline, 3 month, and 6 month
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).
fMRI Anterior Cingulate Neural Response Change
Time frame: Baseline, 3 month, and 6 month
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.
5 secondary outcomes
Sleep Health
Time frame: Baseline, 3 month, and 6 month
Cognitive Function
Time frame: Baseline, 3 month, and 6 month
Structural MRI Change
Time frame: Baseline and 6 month
Cortisol Change
Time frame: Baseline, 3 month, and 6 month
Melatonin Change
Time frame: Baseline, 3 month, and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 39393494Piacquadio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast in people with Obesity, Adolescent, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat Mass Change (time frame: Baseline, 3 month, and 6 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03146442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.