Nutrition Intervention to Measure Metabolic Response in Children

NCT ID: NCT03139773

Last Updated: 2017-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-15

Study Completion Date

2016-11-30

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.

Detailed Description

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Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Normal Weight

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

Group Type EXPERIMENTAL

Control Breakfast Beverage

Intervention Type DIETARY_SUPPLEMENT

Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.

Omega-3 Breakfast Beverage

Intervention Type DIETARY_SUPPLEMENT

Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.

Overweight/Obese

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

Group Type EXPERIMENTAL

Control Breakfast Beverage

Intervention Type DIETARY_SUPPLEMENT

Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.

Omega-3 Breakfast Beverage

Intervention Type DIETARY_SUPPLEMENT

Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.

Interventions

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Control Breakfast Beverage

Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.

Intervention Type DIETARY_SUPPLEMENT

Omega-3 Breakfast Beverage

Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.

Intervention Type DIETARY_SUPPLEMENT

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)
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas, Fayetteville

OTHER

Sponsor Role lead

Responsible Party

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Jamie Baum

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamie I Baum, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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University of Arkansas

Fayetteville, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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15-09-094

Identifier Type: -

Identifier Source: org_study_id

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