Nutrition Intervention to Measure Metabolic Response in Children

May 3, 2017 updated by: Jamie Baum, University of Arkansas, Fayetteville

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72704
        • University of Arkansas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Habitual breakfast consumer
  • No known medical issues

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of breakfast type on energy expenditure four hours postprandial
Time Frame: Change from baseline to 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
Time Frame: Change from baseline to four hours postprandial.
Appetite assessment via visual analog scales
Change from baseline to four hours postprandial.
The effect of breakfast type on appetite hormone secretion
Time Frame: Change from baseline to four hours postprandial.
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.
Time Frame: Fourteen days
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
Time Frame: Baseline and day 14 of each intervention
Plasma insulin, glucose, lipids
Baseline and day 14 of each intervention
Gut microbiota
Time Frame: Baseline and day 14 of each intervention
Assessment of gut microbiome
Baseline and day 14 of each intervention
Proteomic analysis using TMT labeling
Time Frame: Fasting levels at baseline
Proteomic analysis of baseline samples
Fasting levels at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas, Fayetteville

Investigators

  • Principal Investigator: Jamie I Baum, PhD, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2016

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-09-094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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