Development of Melt Organic Baking Fat for Reducing Child Obesity

NCT02346994 | Completed DMC

• 1 other identifier: AAAN3253
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of a cooking oil on metabolic rate, appetite, and metabolic risk markers.

Conditions

Obesity; Overweight; Pediatric Obesity

Keywords

Body Weight; Obesity in Adolescence; Obesity in Childhood; Childhood Onset Obesity; Childhood Obesity; Child Obesity; Adolescent Obesity; Teenagers; Teens; Youth; Adolescents; Adolescence

Outcome Measures

Primary Outcomes (1)

• Thermic effect of food

  An indirect calorimetry cart will measure energy expenditure for approximately 40 minutes out of each hour for 5 hours after breakfast.

  5.5 hours

Secondary Outcomes (2)

• Appetite/satiety measures area under the curve

  5.5 hours

• Insulin, glucose, triglycerides area under the curve

  Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast

Study Arms (2)

Melt test blend 3.2

EXPERIMENTAL

Dietary Supplement: Melt Test Blend 3.2

Corn Oil

ACTIVE COMPARATOR

Dietary Supplement: Corn Oil

Interventions

Melt Test Blend 3.2 DIETARY_SUPPLEMENT

Participant will be given a standard breakfast (containing 20 g of fat from test blend 3.2) to consume over a 10-min period. Test blend 3.2 will be provided in test muffins. The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation. The muffin will provide 450 kcal, and the rest of the energy will be in the form of fat free yogurt, up to 140 kcal, and applesauce.

Melt test blend 3.2

Corn Oil DIETARY_SUPPLEMENT

Participant will be given a standard breakfast (containing 20 g of fat from corn oil) to consume over a 10-min period. Corn oil will be provided in test muffins. The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation. The muffin will provide 450 kcal, and the rest of the energy will be in the form of fat free yogurt, up to 140 kcal, and applesauce.

Corn Oil

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) equal to or greater than 85th percentile for age and sex
• Weight stable (+/- 2.5 kg) for at least 3 months prior to screening

You may not qualify if:

• Any endocrine disorder, including type 1 diabetes
• Weight loss attempted in past 3 months
• Currently using medication (prescription or over-the-counter) that could impact study outcomes
• Asthma
• Anemia
• Diagnosis of psychoses, bipolar disorder, major depression, severe personality disorder; history of suicidal tendencies
• Use of (current or in the past 4 weeks) any investigational medications or devices
• Allergy/sensitivity to wheat, milk, eggs, nuts

Sponsors & Collaborators

• Columbia University: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

New York Nutrition Obesity Research Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Pediatric Obesity; Body Weight

Interventions

Corn Oil

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Marie-Pierre St-Onge, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 27, 2015
• Study Start: January 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

US (1)