Effects of Protein and Fiber at Breakfast on Appetite, Blood Sugar, and Cholesterol

Study Overview
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Brief Summary
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The objectives of the research are to assess the effects of increased protein and fiber intake at breakfast on neural activation in brain regions associated with appetitive drive and reward-driven eating, measures of subjective appetite, and ingestive behavior in overweight adults. Additional outcomes of interest include the effects of the breakfast intervention on blood sugar and cholesterol profiles.

Detailed Description
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The objectives of the research are to assess the effects of increased protein and fiber intake at breakfast on neural activation in brain regions associated with appetitive drive and reward-driven eating, measures of subjective appetite, and ingestive behavior in overweight adults. Additional outcomes of interest include the effects of the breakfast intervention on 24-hour glucose profile as well as fasting and postprandial glycemic and lipemic regulation. The investigators will test the effects of consuming breakfasts with normal protein/normal fiber (NPNF), normal protein/high fiber (NPHF), high protein/normal fiber (HPNF), and high protein/high fiber (HPHF) for two weeks in a randomized cross-over study.

Official Title
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Relative Effects of Chronic Consumption of Egg Protein at Breakfast With and Without Fiber on Brain Neural Activation, Appetite, Glycemic and Lipemic Control and Self-selected Energy Intake

Conditions
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Glucose Control, Brain Activity, Appetite, Ingestive Behavior, Cholesterol

Intervention / Treatment
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* Other: Dietary control of protein and fiber intake at breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female age 21 - 45 years BMI 25-29.9 kg/m2 Exclusion Criteria: Irregular menstrual cycles current smoker medications or supplements that affect appetite pregnant or lactating not weight stable acutely ill diabetic claustrophobic any implantation unsafe in magnetic resonance imaging (MRI) environment

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Average Protein and Fiber at Breakfast<br>Dietary control of protein and fiber intake at breakfast. Participants will eat a 400 kcal breakfast with an average amount of protein and fiber for this age group for 2 weeks. | Other: Dietary control of protein and fiber intake at breakfast<br>* Participants will be provided breakfast meals for 4, 2 week long interventions. The intervention arms are 1) average protein and fiber, 2) average protein and high fiber, 3) high protein and average fiber, and 4) high protein and fiber.<br>|
| Experimental: Average Protein and High Fiber at Breakfast<br>Dietary control of protein and fiber intake at breakfast. Participants will eat a 400 kcal breakfast with an average amount of protein and higher than average amount of fiber for this age group for 2 weeks. | Other: Dietary control of protein and fiber intake at breakfast<br>* Participants will be provided breakfast meals for 4, 2 week long interventions. The intervention arms are 1) average protein and fiber, 2) average protein and high fiber, 3) high protein and average fiber, and 4) high protein and fiber.<br>|
| Experimental: High Protein and Average Fiber at Breakfast<br>Dietary control of protein and fiber intake at breakfast. Participants will eat a 400 kcal breakfast with an average amount of fiber and higher than average amount of protein for this age group for 2 weeks. | Other: Dietary control of protein and fiber intake at breakfast<br>* Participants will be provided breakfast meals for 4, 2 week long interventions. The intervention arms are 1) average protein and fiber, 2) average protein and high fiber, 3) high protein and average fiber, and 4) high protein and fiber.<br>|
| Experimental: Higher Protein and Fiber at Breakfast<br>Dietary control of protein and fiber intake at breakfast. Participants will eat a 400 kcal breakfast with a higher than average amount of protein and fiber for this age group for 2 weeks. | Other: Dietary control of protein and fiber intake at breakfast<br>* Participants will be provided breakfast meals for 4, 2 week long interventions. The intervention arms are 1) average protein and fiber, 2) average protein and high fiber, 3) high protein and average fiber, and 4) high protein and fiber.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activation measured with functional magnetic resonance imaging and its association with measures subjective of appetite, self-selected daily energy intake, and energy intake at an ad libitum lunch. | Aim 1: Assess the effects of a higher than normal protein and fiber intake at breakfast on neural activation of brain regions associated with appetitive drive and reward-driven eating, measures subjective of appetite, self-selected daily energy intake, and energy intake at an ad libitum lunch. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour blood glucose profile | Aim 2: Assess the effects of higher than normal protein and fiber intake at breakfast on 24-hour glucose profile using a continuous glucose monitoring system. | 16 Weeks | 
| Fasting and postprandial blood glucose, insulin, and lipid concentrations | Aim 3: Assess the effects of higher than normal protein and fiber intake at breakfast on fasting and postprandial glycemic and lipemic regulation. | 16 Weeks |