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Nutrition Intervention to Measure Metabolic Response in Children

Primary Purpose

Obesity, Childhood

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Breakfast Beverage
Omega-3 Breakfast Beverage
Sponsored by
University of Arkansas, Fayetteville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity, Childhood

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Habitual breakfast consumer
  • No known medical issues

Exclusion Criteria:

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

Sites / Locations

  • University of Arkansas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal Weight

Overweight/Obese

Arm Description

Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids.

Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids.

Outcomes

Primary Outcome Measures

The effect of breakfast type on energy expenditure four hours postprandial
Energy expenditure will be measured using indirect calorimetry via a TrueMax metabolic cart.
The effect of breakfast type on postprandial appetite
Appetite assessment via visual analog scales
The effect of breakfast type on appetite hormone secretion
Leptin, adiponectin, PYY, and CCK will be measured using ELISA method.
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

Secondary Outcome Measures

Metabolic health measures
Plasma insulin, glucose, lipids
Gut microbiota
Assessment of gut microbiome
Proteomic analysis using TMT labeling
Proteomic analysis of baseline samples

Full Information

First Posted
March 8, 2017
Last Updated
May 3, 2017
Sponsor
University of Arkansas, Fayetteville
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1. Study Identification

Unique Protocol Identification Number
NCT03139773
Brief Title
Nutrition Intervention to Measure Metabolic Response in Children
Official Title
Nutrition Intervention to Improve Energy Metabolism, Energy Intake, and Metabolic Response in Overweight and Obese School-aged Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 15, 2016 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arkansas, Fayetteville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Weight
Arm Type
Experimental
Arm Description
Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids.
Arm Title
Overweight/Obese
Arm Type
Experimental
Arm Description
Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Breakfast Beverage
Intervention Description
Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Breakfast Beverage
Intervention Description
Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.
Primary Outcome Measure Information:
Title
The effect of breakfast type on energy expenditure four hours postprandial
Description
Energy expenditure will be measured using indirect calorimetry via a TrueMax metabolic cart.
Time Frame
Change from baseline to four hours postprandial.
Title
The effect of breakfast type on postprandial appetite
Description
Appetite assessment via visual analog scales
Time Frame
Change from baseline to four hours postprandial.
Title
The effect of breakfast type on appetite hormone secretion
Description
Leptin, adiponectin, PYY, and CCK will be measured using ELISA method.
Time Frame
Change from baseline to four hours postprandial.
Title
The effect of breakfast type on energy expenditure over 14 days of dietary adaptation.
Description
Whole-body energy expenditure will be measured using doubly-labeled water method
Time Frame
Fourteen days
Secondary Outcome Measure Information:
Title
Metabolic health measures
Description
Plasma insulin, glucose, lipids
Time Frame
Baseline and day 14 of each intervention
Title
Gut microbiota
Description
Assessment of gut microbiome
Time Frame
Baseline and day 14 of each intervention
Title
Proteomic analysis using TMT labeling
Description
Proteomic analysis of baseline samples
Time Frame
Fasting levels at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Habitual breakfast consumer No known medical issues Exclusion Criteria: Food allergies Medication Claustrophobic Dietary restrictions Picky eater (determined by parent/guardian)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie I Baum, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Nutrition Intervention to Measure Metabolic Response in Children

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