ObesityNCT02346994
Development of Melt Organic Baking Fat for Reducing Child Obesity
A study testing Melt Test Blend 3.2 and Corn Oil in people with Obesity and Overweight, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of a cooking oil on metabolic rate, appetite, and metabolic risk markers. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Pediatric Obesity
- What is being tested?
- Melt Test Blend 3.2 and Corn Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Nutrition Obesity Research Center
New York, New York, 10032
About this study
Official title: Development and Expansion of Melt Organic Baking Fat for Oxidative Stability and Reducing Child Obesity
The purpose of this study is to compare the effects of a cooking oil on metabolic rate, appetite, and metabolic risk markers.
Read the detailed description
The overall objectives of this study are to determine whether a Melt Organic baking blend can alter energy balance towards a negative energy balance by enhancing thermic effect of food and improving feelings of satiety relative to a control, corn oil, in overweight and obese adolescents.
This study will employ a 2-arm, double-blind, randomized, crossover design. Each arm will consist of one test day and will differ in the type of oil incorporated in the test breakfast: test blend 3.2 or corn oil. Oil sequence will be randomized. Each test day will follow the same protocol and will be separated by at least two weeks for boys or 4 weeks for girls to ensure that testing occurs during the same phase of their menstrual cycle for each test day.
Participants will arrive at the testing center after an overnight 12-h fast. Upon arrival, body weight will be taken and a catheter will be inserted in an antecubital vein. The participant will then rest for 30 minutes, after which resting metabolic rate (RMR) will be measured using an indirect calorimetry cart. RMR will be measured over a 45-min period. At the end of the RMR measurement, a fasting blood sample will be obtained, and the participant will be given a standard breakfast (containing 20 g of fat from either test blend 3.2 or corn oil) to consume over a 10-min period. The fat in the breakfast 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 provided in the form of fat free yogurt, up to 140 kcal, and applesauce.
Following breakfast, postprandial energy expenditure will be assessed every hour using the indirect calorimetry cart. At each hour of this 5-h period, participants will fill out a visual analog scale to assess their feelings of appetite and satiety and will perform a computer task assessing prospective food intake. Immediately after breakfast, and at 30, 45, 60, 120, and 180 minutes after breakfast, a blood sample will be drawn from the catheter for metabolite and hormone measurements.
- Conditions
- Obesity, Overweight, Pediatric Obesity
- Being tested
- Melt Test Blend 3.2, Corn Oil
- Keywords
- Body Weight, Obesity in Adolescence, Obesity in Childhood, Childhood Onset Obesity, Childhood Obesity, Child Obesity, Adolescent Obesity, Teenagers, Teens, Youth, Adolescents, Adolescence
- Medical subject headings
- Obesity, Overweight, Pediatric Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melt Test Blend 3.2Dietary 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.
Corn OilDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Melt test blend 3.2 | Experimental | Not described Receives: Dietary Supplement: Melt Test Blend 3.2 |
| Corn Oil | Active comparator | Not described Receives: Dietary Supplement: Corn Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5.5 hours
Secondary outcomes (2)
Appetite/satiety measures area under the curve
A visual analog scale and a computer program will assess different aspects of appetite and satiety in study participants.
Measured: 5.5 hours
Insulin, glucose, triglycerides area under the curve
Blood draw and analyses will be used to measure triglycerides, glucose, and insulin.
Measured: Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJan 2013
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346994
- Sponsor's protocol ID
- AAAN3253
- Status last verified
- Jan 2017
- First submitted
- 16 Jan 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Expansion of Melt Organic Baking Fat for Oxidative Stability and Reducing Child Obesity
- ClinicalTrials.gov ID
- NCT02346994
- Acronym / sponsor ID
- AAAN3253
- Conditions
- Obesity, Overweight, Pediatric Obesity
- Keywords
- Body Weight, Obesity in Adolescence, Obesity in Childhood, Childhood Onset Obesity, Childhood Obesity, Child Obesity, Adolescent Obesity, Teenagers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Jan 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effects of a cooking oil on metabolic rate, appetite, and metabolic risk markers.
Detailed description
The overall objectives of this study are to determine whether a Melt Organic baking blend can alter energy balance towards a negative energy balance by enhancing thermic effect of food and improving feelings of satiety relative to a control, corn oil, in overweight and obese adolescents.
This study will employ a 2-arm, double-blind, randomized, crossover design. Each arm will consist of one test day and will differ in the type of oil incorporated in the test breakfast: test blend 3.2 or corn oil. Oil sequence will be randomized. Each test day will follow the same protocol and will be separated by at least two weeks for boys or 4 weeks for girls to ensure that testing occurs during the same phase of their menstrual cycle for each test day.
Participants will arrive at the testing center after an overnight 12-h fast. Upon arrival, body weight will be taken and a catheter will be inserted in an antecubital vein. The participant will then rest for 30 minutes, after which resting metabolic rate (RMR) will be measured using an indirect calorimetry cart. RMR will be measured over a 45-min period. At the end of the RMR measurement, a fasting blood sample will be obtained, and the participant will be given a standard breakfast (containing 20 g of fat from either test blend 3.2 or corn oil) to consume over a 10-min period. The fat in the breakfast 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 provided in the form of fat free yogurt, up to 140 kcal, and applesauce.
Following breakfast, postprandial energy expenditure will be assessed every hour using the indirect calorimetry cart. At each hour of this 5-h period, participants will fill out a visual analog scale to assess their feelings of appetite and satiety and will perform a computer task assessing prospective food intake. Immediately after breakfast, and at 30, 45, 60, 120, and 180 minutes after breakfast, a blood sample will be drawn from the catheter for metabolite and hormone measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melt test blend 3.2 | Experimental | Dietary Supplement: Melt Test Blend 3.2 |
| Corn Oil | Active comparator | Dietary Supplement: Corn Oil |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melt Test Blend 3.2Participant 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. | Dietary supplement | Melt test blend 3.2 |
| Corn OilParticipant 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. | Dietary supplement | Corn Oil |
Primary outcome
Thermic effect of food
Time frame: 5.5 hours
An indirect calorimetry cart will measure energy expenditure for approximately 40 minutes out of each hour for 5 hours after breakfast.
2 secondary outcomes
Appetite/satiety measures area under the curve
Time frame: 5.5 hours
Insulin, glucose, triglycerides area under the curve
Time frame: Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Pierre St-Onge, Ph.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melt Test Blend 3.2 and Corn Oil in people with Obesity and Overweight, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermic effect of food (time frame: 5.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.