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Completed

NCT Number: NCT03139773

Nutrition Intervention to Measure Metabolic Response in 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.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Habitual breakfast consumer
  • No known medical issues

Exclusion criteria

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

Treatment and study plan

Control Breakfast Beverage

Dietary Supplement

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

Omega-3 Breakfast Beverage

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. The effect of breakfast type on postprandial appetite

    Time frame: Change from baseline to four hours postprandial.

    Appetite assessment via visual analog scales

  3. 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.

  4. 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

Secondary outcomes

  1. Metabolic health measures

    Time frame: Baseline and day 14 of each intervention

    Plasma insulin, glucose, lipids

  2. Gut microbiota

    Time frame: Baseline and day 14 of each intervention

    Assessment of gut microbiome

  3. Proteomic analysis using TMT labeling

    Time frame: Fasting levels at baseline

    Proteomic analysis of baseline samples

Sponsors and collaborators

Lead sponsor

University of Arkansas, Fayetteville

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 4, 2017
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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