NCT01720589

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

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

October 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

October 17, 2012

Last Update Submit

May 28, 2013

Conditions

Childhood Obesity

Keywords

ObesityDietary fatEnergy expenditureFood intake

Outcome Measures

Primary Outcomes (3)

  • Thermic effect of food

    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.

    6 h

  • Respiratory quotient/fat oxidation

    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.

    6 h

  • Food intake

    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

    single meal

Secondary Outcomes (7)

  • Glucose

    6 h

  • Feelings of appetite and satiety

    6 h

  • Insulin

    6 hours

  • Leptin

    6 hours

  • Ghrelin

    6 hours

  • +2 more secondary outcomes

Study Arms (2)

Melt (test oil)

EXPERIMENTAL

Participants will consume a muffin containing 20 g of dietary fat provided by the test oil and their energy expenditure will be measure post-prandially for 6 hours. At the end of the measurement period, participants will consume a cookie containing 10 g of fat provided by the test oil and their food intake at an ad libitum meal will be measured 1 hour later.

Dietary Supplement: Melt (test oil)

Corn oil (control)

ACTIVE COMPARATOR

Participants will consume a muffin containing 20 g of dietary fat provided by the control oil and their energy expenditure will be measure post-prandially for 6 hours. At the end of the measurement period, participants will consume a cookie containing 10 g of fat provided by the control oil and their food intake at an ad libitum meal will be measured 1 hour later.

Dietary Supplement: Corn oil (control)

Interventions

Melt (test oil)DIETARY_SUPPLEMENT
Melt (test oil)
Corn oil (control)DIETARY_SUPPLEMENT
Corn oil (control)

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's/Roosevelt Hospital

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Interventions

FreezingCorn Oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phase TransitionPhysical PhenomenaCold TemperatureTemperatureThermodynamicsChemical PhenomenaDietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Marie-Pierre St-Onge, Ph.D

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

  • Cygnia Rapp

    Prosperity Organic Foods

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

October 17, 2012

First Posted

November 2, 2012

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

US(1)