Increased Protein at Breakfast for Weight Management in Overweight Adolescents
Condition: Obesity, Adolescent
MeSH terms: Overweight; Pediatric Obesity
Study type: Interventional

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.
    

Intervention name(s): Breakfast
Intervention type(s): Behavioral
Intervention description(s): For 6 months, the participants will either skip breakfast or will habitually consume a NP or HP breakfast every day.
Allocation: Randomized
Intervention model: Factorial Assignment
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)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: increased dietary protein; breakfast; weight management; satiety; glucose control; fMRI; cognitive performance; memory; attention; executive function; structural MRI; sleep quality