Nutrition Intervention to Measure Metabolic Response in Children

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03139773

Enrollment

Registered

2017-05-04

Start date

2016-05-15

Completion date

2016-11-30

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

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.

Interventions

DIETARY_SUPPLEMENTControl Breakfast Beverage

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

DIETARY_SUPPLEMENTOmega-3 Breakfast Beverage

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

8 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

* Habitual breakfast consumer * No known medical issues

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
The effect of breakfast type on energy expenditure four hours postprandial	Change from baseline to four hours postprandial.	Energy expenditure will be measured using indirect calorimetry via a TrueMax metabolic cart.
The effect of breakfast type on postprandial appetite	Change from baseline to four hours postprandial.	Appetite assessment via visual analog scales
The effect of breakfast type on appetite hormone secretion	Change from baseline to four hours postprandial.	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.	Fourteen days	Whole-body energy expenditure will be measured using doubly-labeled water method

Secondary

Measure	Time frame	Description
Gut microbiota	Baseline and day 14 of each intervention	Assessment of gut microbiome
Metabolic health measures	Baseline and day 14 of each intervention	Plasma insulin, glucose, lipids
Proteomic analysis using TMT labeling	Fasting levels at baseline	Proteomic analysis of baseline samples

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026