Nutrition Intervention to Measure Metabolic Response in Children

University of Arkansas, Fayetteville27 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Obesity, Childhood

Interventions

Control Breakfast BeverageDIETARY_SUPPLEMENT

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

Omega-3 Breakfast BeverageDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Habitual breakfast consumer * No known medical issues Exclusion Criteria: * Food allergies * Medication * Claustrophobic * Dietary restrictions * Picky eater (determined by parent/guardian)

Locations (1)

University of Arkansas

Fayetteville, Arkansas, United States

Outcomes

Primary Outcomes

The effect of breakfast type on energy expenditure four hours postprandial

Energy expenditure will be measured using indirect calorimetry via a TrueMax metabolic cart.

Time frame: Change from baseline to four hours postprandial.

The effect of breakfast type on postprandial appetite

Appetite assessment via visual analog scales

Time frame: 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.

Time frame: 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

Time frame: Fourteen days

Secondary Outcomes

Metabolic health measures

Plasma insulin, glucose, lipids

Time frame: Baseline and day 14 of each intervention

Gut microbiota

Assessment of gut microbiome

Time frame: Baseline and day 14 of each intervention

Proteomic analysis using TMT labeling

Proteomic analysis of baseline samples

Time frame: Fasting levels at baseline

Data from ClinicalTrials.gov

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