Clinical trial NCT03146442: Increased Protein at Breakfast for Weight Management in Overweight Adolescents
Official title: Increased Protein at Breakfast for Weight Management in Overweight Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Adolescent
Keywords: increased dietary protein
breakfast
weight management
satiety
glucose control
fMRI
cognitive performance
memory
attention
executive function
structural MRI
sleep quality
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: University of Kansas Medical Center
name: University of Tennessee
First posted: 2017-05-10
Enrollment: 103
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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)
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fat Mass Change
timeFrame: Baseline, 3 month, and 6 month
measure: 3-day Average Daily Intake Change
timeFrame: Baseline, 3 month, and 6 month
measure: Glucose Excursions Change
timeFrame: Baseline, 3 month, and 6 month
measure: PYY Change
timeFrame: Baseline, 3 month, and 6 month
measure: Fullness Change
timeFrame: Baseline, 3 month, and 6 month
measure: Cravings for Fats Change
timeFrame: Baseline, 3 month, and 6 month
measure: fMRI Anterior Cingulate Neural Response Change
timeFrame: Baseline, 3 month, and 6 month
Secondary outcomes:
measure: Sleep Health
timeFrame: Baseline, 3 month, and 6 month
measure: Cognitive Function
timeFrame: Baseline, 3 month, and 6 month
measure: Structural MRI Change
timeFrame: Baseline and 6 month
measure: Cortisol Change
timeFrame: Baseline, 3 month, and 6 month
measure: Melatonin Change
timeFrame: Baseline, 3 month, and 6 month
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References: