OverweightMuffinNCT00529919
Effects of Medium Chain Triglyceride Oil, Versus Olive Oil, for Weight Loss
A study testing Weight loss in people with Overweight, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The primary aim of this research project is to determine whether the incorporation of food products containing medium chain triglyceride (MCT) oil in a weight-loss program results in a different degree of weight-loss and total and regional fat mass loss than the incorporation of extra light olive oil. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Weight loss
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jun 2007
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index 27-33 kg/m2
- pre-menopausal women
- weight stable for at least 6 months
- normal score on Brief Symptoms Inventory questionnaire
Who cannot join
- chronic disease
- weight loss treatment
- medication known to affect body weight
- unstable blood pressure, glucose, lipid levels
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: The Effects of a Weight Loss Diet Containing Medium Chain Triglyceride Oil, Versus Olive Oil, on Body Composition in Free-Living Adults
The primary aim of this research project is to determine whether the incorporation of food products containing medium chain triglyceride (MCT) oil in a weight-loss program results in a different degree of weight-loss and total and regional fat mass loss than the incorporation of extra light olive oil. The secondary goals are to test whether there are differences in in metabolic risk profile changes between the 2 diets. We hypothesize that men and women who consumed MCT oil as part of their weight loss program will lose more weight and body fat than those who consume olive oil in their weight loss diet.
- Conditions
- Overweight
- Being tested
- Weight loss
- Keywords
- Overweight, Obesity, Weight loss, Medium chain triglycerides, Cardiovascular disease risk
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossDietary supplement
Also called MCT oil, Neobee 1053, Stepan Company
Weight loss study including consumption of either 22-25 g of medium chain triglyceride oil or olive oil
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MCT oil consumption Receives: Dietary Supplement: Weight loss |
| 2 | Placebo comparator | Olive oil consumption Receives: Dietary Supplement: Weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight and fat mass, change in plasma lipid concentrations, fasting glucose and fasting insulin
Measured: 16 weeks
Secondary outcomes (1)
Change in blood pressure, change in fat-free mass
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startMar 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- International Life Sciences Institute
- Investigators
- Marie-Pierre St-Onge, Ph.D, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529919
- Sponsor's protocol ID
- F050124003
- Acronym
- Muffin
- Status last verified
- Sep 2007
- First submitted
- 12 Sep 2007
- Last updated
- 14 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
St-Onge MP, Bosarge A, Goree LL, Darnell B. Medium chain triglyceride oil consumption as part of a weight loss diet does not lead to an adverse metabolic profile when compared to olive oil. J Am Coll Nutr. 2008 Oct;27(5):547-52. doi: 10.1080/07315724.2008.10719737.
PubMed 18845704
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Weight Loss Diet Containing Medium Chain Triglyceride Oil, Versus Olive Oil, on Body Composition in Free-Living Adults
- ClinicalTrials.gov ID
- NCT00529919
- Acronym / sponsor ID
- Muffin / F050124003
- Conditions
- Overweight
- Keywords
- Overweight, Obesity, Weight loss, Medium chain triglycerides, Cardiovascular disease risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- International Life Sciences Institute
- Study start
- Mar 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 14 Sep 2007 (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 primary aim of this research project is to determine whether the incorporation of food products containing medium chain triglyceride (MCT) oil in a weight-loss program results in a different degree of weight-loss and total and regional fat mass loss than the incorporation of extra light olive oil. The secondary goals are to test whether there are differences in in metabolic risk profile changes between the 2 diets. We hypothesize that men and women who consumed MCT oil as part of their weight loss program will lose more weight and body fat than those who consume olive oil in their weight loss diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Weight lossMCT oil consumption |
| 2 | Placebo comparator | Dietary Supplement: Weight lossOlive oil consumption |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- body mass index 27-33 kg/m2
- pre-menopausal women
- weight stable for at least 6 months
- normal score on Brief Symptoms Inventory questionnaire
Key exclusion criteria (4 listed)
- chronic disease
- weight loss treatment
- medication known to affect body weight
- unstable blood pressure, glucose, lipid levels
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 |
|---|---|---|
| Weight lossAlso: MCT oil, Neobee 1053, Stepan CompanyWeight loss study including consumption of either 22-25 g of medium chain triglyceride oil or olive oil | Dietary supplement | 1, 2 |
Primary outcome
Change in body weight and fat mass, change in plasma lipid concentrations, fasting glucose and fasting insulin
Time frame: 16 weeks
1 secondary outcome
Change in blood pressure, change in fat-free mass
Time frame: 16 weeks
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 14 Sep 2007.
- Derived from this study: PubMed 18845704St-Onge MP, Bosarge A, Goree LL, Darnell B. Medium chain triglyceride oil consumption as part of a weight loss diet does not lead to an adverse metabolic profile when compared to olive oil. J Am Coll Nutr. 2008 Oct;27(5):547-52. doi: 10.1080/07315724.2008.10719737.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss in people with Overweight, run by University of Alabama at Birmingham 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 4 inclusion and 4 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 14 Sep 2007. 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. Some participants in this study may receive a placebo. 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?
Change in body weight and fat mass, change in plasma lipid concentrations, fasting glucose and fasting insulin (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00529919, which also lists 1 linked publication.
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 14 Sep 2007.