Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03146442
Study type Interventional
Source University of Texas at Austin
Contact
Status Completed
Phase N/A
Start date August 1, 2017
Completion date April 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT03358524 - Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia Phase 4
Active, not recruiting NCT04213014 - Guys/Girls Opt for Activities for Life Trial (GOAL) to Increase Young Adolescents' Physical Activity and Healthy Eating N/A
Active, not recruiting NCT06089876 - The Use of Mobile Applications in Obese and Overweight Adolescents for Health Improvement N/A
Recruiting NCT05030636 - Novel Role of Exercise Timing in Obesity N/A
Completed NCT02952170 - Impact of Weight Loss Surgery in Adolescents With NAFLD N/A
Recruiting NCT03963557 - Cognitive Function and Body Mass Index in Children and Adolescents
Completed NCT04044833 - Evaluation of the Effects of Planned Trainings Given to Obese Adolescent Girls on Healthy Lifestyle Behaviors and Menstrual Symptoms
Completed NCT05095883 - Correlation Between Body Weight and Foot Progression Angle in Adolescents
Withdrawn NCT05834062 - Phentermine/Topiramate as Preventive Pharmacotherapy for Obesity Phase 2
Completed NCT06152068 - Insulin Resistance, Lipid Profile, CRP, IL-18 and Carotid Intima-Media Thickness (CIMT) Diameter in Obese Adolescents
Enrolling by invitation NCT04094324 - Mental Health in Children and Youth Within Pediatric Care
Not yet recruiting NCT05984043 - Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences N/A
Not yet recruiting NCT02973867 - Myokines Role During Obesity N/A
Active, not recruiting NCT04252677 - Health Literacy and Obesogenic Behaviors N/A
Active, not recruiting NCT04719052 - Mediterranean Enriched Diet for Tackling Youth Obesity N/A
Completed NCT05966870 - Unsweetened Sparkling Water and Changes in Sweetness Perception in Adolescents N/A
Recruiting NCT05393570 - Lifestyle Improvement for Teens With Bariatric Surgery N/A
Enrolling by invitation NCT05778266 - Effect of L-citrulline and HIIT on Arterial Stiffness and MAFLD in Adolescents N/A
Completed NCT06377137 - High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction N/A
Completed NCT04780828 - Investigation of the Effects of Different Levels of Obesity on the Respiratory System