The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents
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|ClinicalTrials.gov Identifier: NCT01192100|
Recruitment Status : Completed
First Posted : August 31, 2010
Last Update Posted : October 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Breakfast Skipping Behavioral: Normal Protein Breakfast Meals Behavioral: Protein-rich Breakfast Meals||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||August 2011|
Experimental: Breakfast Skipping
Breakfast skipping serves as the baseline/control arm since the participants habitually skip breakfast (i.e., skip breakfast at least 5 times/week). Thus, during the week prior to and including the testing day, the participants will continue to skip breakfast each morning.
Behavioral: Breakfast Skipping
Participants will continue to skip breakfast each morning.
Other Name: Control
Experimental: Normal Protein Breakfast Meals
For 7 days, the participants will consume normal protein breakfast meals each morning. These meals will consist of cereal-based foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 15% protein (13 g of dietary protein), 65% CHO, and 20% fat.
Behavioral: Normal Protein Breakfast Meals
Participants will consume normal protein breakfast meals each morning.
Experimental: Protein-rich Breakfast Meals
For 7 days, the participants will consume protein-rich breakfast meals each morning. These meals will consist of home-cooked foods and will be 350 kcal, which is approximately 18% of daily energy intake for overweight and obese adolescents ages 9-18 y. The macronutrient composition of these meals will contain 40% protein (35 g of protein), 40% CHO, and 20% fat.
Behavioral: Protein-rich Breakfast Meals
Participants will consume protein-rich breakfast meals each morning.
- Perceived Appetite and Satiety [ Time Frame: 5 weeks ]Questionnaires, assessing appetite sensations (i.e., hunger, fullness, prospective food consumption, motivation to eat), hedonic ratings (pleasure), and palatability will be completed throughout each of the testing days (which are separated by 2 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
- Appetite and Satiety Hormones (i.e., Ghrelin, PYY) [ Time Frame: 5 weeks ]25 total blood samples will be drawn throughout each of the testing days (which are separated by 2 weeks). Specifically, there will be 5 ml/sample; 125 ml (4.2 oz)/testing day. The samples will be collected in test tubes containing EDTA (ethylenediaminetetraacetic acid). Protease inhibitors will be added to the sample to reduce protein degradation. Samples will be centrifuged at -4°C for 15 minutes. The plasma will then be separated and stored in microcentrifuge tubes at -80°C for future analysis. Plasma total ghrelin and total PYY will be measure.
- Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses [ Time Frame: 5 weeks ]Brain activation responses will be assessed prior to dinner in each of the 3 testing days (separated by 2 weeks). During the fMRI brain scan procedure, the participants will focus on a set of photographs which will be projected onto a screen and easily viewed through a mirror. The fMRI paradigm incorporates stimuli from three categories of pictures including food, nonfood (animals), and blurred baseline images. Brain activation in the Insula, Amygdala, Hippocampus, and Parahippocampus will be examined when viewing food vs. animal pictures.
- Daily Energy Intake [ Time Frame: 5 weeks ]Energy intake during breakfast, lunch, dinner, and evening snacks of each testing day will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192100
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65211|
|Principal Investigator:||Heather J Leidy, MD||University of Missouri-Columbia|