NCT03139773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

March 8, 2017

Last Update Submit

May 3, 2017

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (4)

  • 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.

  • The effect of breakfast type on postprandial appetite

    Appetite assessment via visual analog scales

    Change from baseline to four hours postprandial.

  • 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.

  • 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 Outcomes (3)

  • Metabolic health measures

    Baseline and day 14 of each intervention

  • Gut microbiota

    Baseline and day 14 of each intervention

  • Proteomic analysis using TMT labeling

    Fasting levels at baseline

Study Arms (2)

Normal Weight

EXPERIMENTAL

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

Dietary Supplement: Control Breakfast BeverageDietary Supplement: Omega-3 Breakfast Beverage

Overweight/Obese

EXPERIMENTAL

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

Dietary Supplement: Control Breakfast BeverageDietary Supplement: Omega-3 Breakfast Beverage

Interventions

Control Breakfast BeverageDIETARY_SUPPLEMENT

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

Normal WeightOverweight/Obese
Omega-3 Breakfast BeverageDIETARY_SUPPLEMENT

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

Normal WeightOverweight/Obese

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Habitual breakfast consumer
  • No known medical issues

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jamie I Baum, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 8, 2017

First Posted

May 4, 2017

Study Start

May 15, 2016

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)