Childhood ObesityMeltNCT01720589
Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children
A study testing Melt (test oil) in people with Childhood Obesity, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Melt (test oil)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Feb 2013
- 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
- age 15-18
- body mass index 85% percentile or higher for age/sex
- weight stable
Who cannot join
- ±5 lbs weight change in the the 3 months prior
- use of medications
- dietary allergies
- metabolic disorder
- eating disorder
- behavioral or psychological disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's/Roosevelt Hospital
New York, New York, 10025
About this study
Official title: Development of Rich & Creamy Melt® Organic Cooking Blend for Oxidative Stability and Reducing Childhood Obesity
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.
- Conditions
- Childhood Obesity
- Being tested
- Melt (test oil), Corn oil (control)
- Keywords
- Obesity, Dietary fat, Energy expenditure, Food intake
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melt (test oil)Dietary supplement
Corn oil (control)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Corn oil (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: single meal
Secondary outcomes (7)
Glucose
Measurement of glucose over 6 hours after consumption of the test oil and control oil
Measured: 6 h
Feelings of appetite and satiety
Measurement of feelings of appetite and satiety by visual analog scales over 6 hours after consumption of the test oil and control oil
Measured: 6 h
Insulin
Measurement of insulin over 6 hours after consumption of the test oil and control oil
Measured: 6 hours
Leptin
Measurement of leptin over 6 hours after consumption of the test oil and control oil
Measured: 6 hours
Ghrelin
Measurement of ghrelin over 6 hours after consumption of the test oil and control oil
Measured: 6 hours
Peptide YY
Measurement of peptide YY over 6 hours after consumption of the test oil and control oil
Measured: 6 hours
Glucagon like peptide 1
Measurement of glucagon like peptide 1 over 6 hours after consumption of the test oil and control oil
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Prosperity Organic Foods, USDA Beltsville Human Nutrition Research Center
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, St. Luke's-Roosevelt Hospital Center
- Investigators
- Marie-Pierre St-Onge, Ph.D, Principal investigator, St. Luke's-Roosevelt Hospital CenterCygnia Rapp, Principal investigator, Prosperity Organic Foods
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720589
- Sponsor's protocol ID
- 2012-33610-19482
- Acronym
- Melt
- Status last verified
- May 2013
- First submitted
- 17 Oct 2012
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Rich & Creamy Melt® Organic Cooking Blend for Oxidative Stability and Reducing Childhood Obesity
- ClinicalTrials.gov ID
- NCT01720589
- Acronym / sponsor ID
- Melt / 2012-33610-19482
- Conditions
- Childhood Obesity
- Keywords
- Obesity, Dietary fat, Energy expenditure, Food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Prosperity Organic Foods, USDA Beltsville Human Nutrition Research Center
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Nov 2012 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melt (test oil) | Experimental | Dietary Supplement: Melt (test oil)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. |
| Corn oil (control) | Active comparator | Dietary Supplement: Corn oil (control)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. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 15-18
- body mass index 85% percentile or higher for age/sex
- weight stable
Key exclusion criteria (6 listed)
- ±5 lbs weight change in the the 3 months prior
- use of medications
- dietary allergies
- metabolic disorder
- eating disorder
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 oil) | Dietary supplement | Melt (test oil) |
| Corn oil (control) | Dietary supplement | Corn oil (control) |
Primary outcome
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.
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.
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
7 secondary outcomes
Glucose
Time frame: 6 h
Feelings of appetite and satiety
Time frame: 6 h
Insulin
Time frame: 6 hours
Leptin
Time frame: 6 hours
Ghrelin
Time frame: 6 hours
Peptide YY
Time frame: 6 hours
Glucagon like peptide 1
Time frame: 6 hours
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 30 May 2013.
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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
St. Luke's-Roosevelt Hospital Center
Cygnia Rapp principal investigator
Prosperity Organic Foods
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 oil) in people with Childhood Obesity, run by St. Luke's-Roosevelt Hospital Center 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 3 inclusion and 6 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 30 May 2013. 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: 6 h). The study lists 3 primary outcomes in all. 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 30 May 2013.