Nutrition Intervention to Measure Metabolic Response in Children

Not Applicable

Completed

• Conditions: Obesity, Childhood
• Interventions: Dietary Supplement: Control Breakfast Beverage; Dietary Supplement: Omega-3 Breakfast Beverage

• Registration Number: NCT03139773
• Lead Sponsor: University of Arkansas, Fayetteville

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-15
• Primary Completion: 2016-11-30
• Study Completion: 2016-11-30
• Study First Submitted: 2017-03-08
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-01
• Last Update Submitted: 2017-05-03
• Study First Posted: 2017-05-04
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Habitual breakfast consumer
• No known medical issues

Exclusion Criteria

• Food allergies
• Medication
• Claustrophobic
• Dietary restrictions
• Picky eater (determined by parent/guardian)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal Weight	Control Breakfast Beverage	Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids.
Normal Weight	Omega-3 Breakfast Beverage	Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids.
Overweight/Obese	Control Breakfast Beverage	Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids.
Overweight/Obese	Omega-3 Breakfast Beverage	Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Metabolic health measures	Baseline and day 14 of each intervention	Plasma insulin, glucose, lipids
Proteomic analysis using TMT labeling	Fasting levels at baseline	Proteomic analysis of baseline samples
Gut microbiota	Baseline and day 14 of each intervention	Assessment of gut microbiome

Trial Locations

Locations (1)

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States