Nutrition Intervention to Measure Metabolic Response in Children

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139773
• Other study ID #: 15-09-094
• Status: Completed
• Phase: N/A
• First received: March 8, 2017
• Last updated: May 3, 2017
• Start date: May 15, 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: May 2017
• Source: University of Arkansas, Fayetteville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Habitual breakfast consumer

• No known medical issues

Exclusion Criteria:

• Food allergies

• Medication

• Claustrophobic

• Dietary restrictions

• Picky eater (determined by parent/guardian)

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Dietary Supplement:
• Control Breakfast Beverage
Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.
• Omega-3 Breakfast Beverage
Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.

Locations

Country	Name	City	State
United States	University of Arkansas	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas, Fayetteville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	The effect of breakfast type on postprandial appetite	Appetite assessment via visual analog scales	Change from baseline to four hours postprandial.
Primary	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.
Primary	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	Metabolic health measures	Plasma insulin, glucose, lipids	Baseline and day 14 of each intervention
Secondary	Gut microbiota	Assessment of gut microbiome	Baseline and day 14 of each intervention
Secondary	Proteomic analysis using TMT labeling	Proteomic analysis of baseline samples	Fasting levels at baseline