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Completed

NCT Number: NCT01720589

Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children

The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich in medium chain triglycerides on energy expenditure and food intake in overweight and obese children.

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Key information

Conditions

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

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Luke's/Roosevelt Hospital

New York, 10025, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age 15-18
  • body mass index 85% percentile or higher for age/sex
  • weight stable

Exclusion criteria

  • ±5 lbs weight change in the the 3 months prior
  • use of medications
  • dietary allergies
  • metabolic disorder
  • eating disorder
  • behavioral or psychological disorders

Treatment and study plan

Melt (test oil)

Dietary Supplement

Corn oil (control)

Dietary Supplement

Primary outcomes

  1. Thermic effect of food

    Time frame: 6 h

    Measurement of thermic effect of food over 6 hours after a meal rich in test oil and control oil. The thermic effect of food is the difference between post-prandial energy expenditure and basal energy expenditure. We will assess the difference in thermic effect of food over a 6-hour period between the test oil and the control oil.

  2. Respiratory quotient/fat oxidation

    Time frame: 6 h

    Measurement of substrate oxidation by indirect calorimetry over 6 hours after consumption of the test oil and control oil. We will specifically calculate carbohydrate and fat oxidation rates over the 6-hour period post-prandially and compare rates of oxidation of these two substrates between the test oil and the control oil.

  3. Food intake

    Time frame: single meal

    Measurement of food intake at a single meal served 1 hour after a pre-load containing 8-10 g of the test oil and the control oil

Secondary outcomes

  1. Glucose

    Time frame: 6 h

    Measurement of glucose over 6 hours after consumption of the test oil and control oil

  2. Feelings of appetite and satiety

    Time frame: 6 h

    Measurement of feelings of appetite and satiety by visual analog scales over 6 hours after consumption of the test oil and control oil

  3. Insulin

    Time frame: 6 hours

    Measurement of insulin over 6 hours after consumption of the test oil and control oil

  4. Leptin

    Time frame: 6 hours

    Measurement of leptin over 6 hours after consumption of the test oil and control oil

  5. Ghrelin

    Time frame: 6 hours

    Measurement of ghrelin over 6 hours after consumption of the test oil and control oil

  6. Peptide YY

    Time frame: 6 hours

    Measurement of peptide YY over 6 hours after consumption of the test oil and control oil

  7. Glucagon like peptide 1

    Time frame: 6 hours

    Measurement of glucagon like peptide 1 over 6 hours after consumption of the test oil and control oil

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Collaborators

  • Prosperity Organic Foods
  • USDA Beltsville Human Nutrition Research Center

Registry information

Official study title

Development of Rich & Creamy Melt® Organic Cooking Blend for Oxidative Stability and Reducing Childhood Obesity

Acronym: Melt

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 2, 2012
Registry last updated
May 30, 2013

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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