Nutrition Intervention to Measure Metabolic Response in Children

Study Overview
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Brief Summary
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The long-term objective of this study is to determine if habitual consumption of high-quality protein at breakfast will lead to improved energy metabolism and decreased daily energy intake in normal weight and overweight children. The investigators hypothesize that increasing protein intake at breakfast will improve energy metabolism and reduce energy intake throughout the day in overweight/obese school-aged children. The significance of the study is that improving nutrient intake at breakfast can potentially lead to a future reduction in childhood obesity rates.

Official Title
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Nutrition Intervention to Improve Energy Metabolism, Energy Intake, and Metabolic Response in Overweight and Obese School-aged Children

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Dietary Supplement: Control Breakfast Beverage
* Dietary Supplement: Omega-3 Breakfast Beverage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Habitual breakfast consumer No known medical issues Exclusion Criteria: Food allergies Medication Claustrophobic Dietary restrictions Picky eater (determined by parent/guardian)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Weight<br>Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids. | Dietary Supplement: Control Breakfast Beverage<br>* Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.<br>Dietary Supplement: Omega-3 Breakfast Beverage<br>* Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.<br>|
| Experimental: Overweight/Obese<br>Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids. | Dietary Supplement: Control Breakfast Beverage<br>* Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.<br>Dietary Supplement: Omega-3 Breakfast Beverage<br>* Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of breakfast type on energy expenditure four hours postprandial | Energy expenditure will be measured using indirect calorimetry via a TrueMax metabolic cart. | Change from baseline to four hours postprandial. | 
| The effect of breakfast type on postprandial appetite | Appetite assessment via visual analog scales | Change from baseline to four hours postprandial. | 
| The effect of breakfast type on appetite hormone secretion | Leptin, adiponectin, PYY, and CCK will be measured using ELISA method. | Change from baseline to four hours postprandial. | 
| The effect of breakfast type on energy expenditure over 14 days of dietary adaptation. | Whole-body energy expenditure will be measured using doubly-labeled water method | Fourteen days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic health measures | Plasma insulin, glucose, lipids | Baseline and day 14 of each intervention | 
| Gut microbiota | Assessment of gut microbiome | Baseline and day 14 of each intervention | 
| Proteomic analysis using TMT labeling | Proteomic analysis of baseline samples | Fasting levels at baseline |