Increased Protein at Breakfast for Weight Management in Overweight Adolescents

NCT ID: NCT03146442

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2023-04-30

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.

Conditions

Obesity, Adolescent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Normal Protein (NP) Breakfast

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.

Group Type: ACTIVE_COMPARATOR

Breakfast

Intervention Type: BEHAVIORAL

For 6 months, the participants will either skip breakfast or will habitually consume a NP or HP breakfast every day.

High Protein (HP) Breakfast

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.

Group Type: EXPERIMENTAL

Breakfast

Intervention Type: BEHAVIORAL

For 6 months, the participants will either skip breakfast or will habitually consume a NP or HP breakfast every day.

Breakfast Skipping (BS)

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.

Group Type: PLACEBO_COMPARATOR

Breakfast

Intervention Type: BEHAVIORAL

For 6 months, the participants will either skip breakfast or will habitually consume a NP or HP breakfast every day.

Interventions

Breakfast

For 6 months, the participants will either skip breakfast or will habitually consume a NP or HP breakfast every day.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

University of Tennessee

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Heather Leidy

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Texas at Austin

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39393494 (View on PubMed)

Other Identifiers

1611018490

Identifier Type: -

Identifier Source: org_study_id