Trials / Completed
CompletedNCT01192100
The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- University of Missouri-Columbia · Academic / Other
- Sex
- Female
- Age
- 15 Years – 20 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess whether the daily addition of a protein-rich breakfast leads to beneficial changes in appetite control, food intake regulation,and cognitive function in overweight \& obese 'breakfast skipping' young women.
Detailed description
Breakfast skipping, which is a common, yet unhealthy dietary habit among young women, has been strongly associated with over-eating (especially in the evening), weight gain, and obesity. Breakfast skipping has also been shown to reduce cognitive function in this population. However, it is unclear as to whether the addition of breakfast, with specific emphasis on increased dietary protein, leads to improvements in these outcomes. This study will provide mechanistic evidence supporting the addition of a protein-rich breakfast to improve and/or re-establish appetite control, energy intake regulation, and cognitive function in overweight/obese 'breakfast skipping' young women. 22 overweight and obese 'breakfast skipping' adolescent girls will participate in the following randomized within-subject crossover-design breakfast study. The participants will randomly complete the follow breakfast patterns at home for 6 days: 1) Breakfast Skipping; 2) Consumption of Normal Protein breakfast meals(i.e., 350 kcal; 15% of the meal as protein, 65% CHO, \& 20% fat); and 3) Consumption of Protein-Rich breakfast meals (i.e., 350 kcal; 40% of the meal as protein, 40% CHO, \& 20% fat). On the 7th day of each pattern, the participants will report to the MU-Brain Imaging Center in the morning to complete the respective 10-h testing day. The participants will begin the testing day by either skipping breakfast or consuming their respective breakfast meal. Blood samples and assessments of perceived appetite, pleasure/reward, and cognitive function will be collected/completed at specific times throughout the day. A standardized lunch will also be provided. Prior to dinner, a brain scan will be completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food pictures. Following the fMRI, the participants will be provided with an ad libitum dinner buffet to consume of the facility. They will also be given evening snacks to consume ad libitum, at home throughout the remainder of the day. There is a 7-day washout period between each breakfast pattern. Primary outcomes include morning, mid-day, afternoon, and evening appetite, satiety, pleasure/reward, hormonal responses (plasma glucose, insulin, ghrelin, and PYY concentrations), brain activation patterns, evening energy intake, and daily energy intake.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Breakfast Skipping | Participants will continue to skip breakfast each morning. |
| BEHAVIORAL | Normal Protein Breakfast Meals | Participants will consume normal protein breakfast meals each morning. |
| BEHAVIORAL | Protein-rich Breakfast Meals | Participants will consume protein-rich breakfast meals each morning. |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2011-05-01
- Completion
- 2011-08-01
- First posted
- 2010-08-31
- Last updated
- 2020-04-03
- Results posted
- 2020-04-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01192100. Inclusion in this directory is not an endorsement.