People Who Are Overweight or ObesityPhase 2NCT00644098
Effect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors
A Phase 2 study testing soluble fibre complex and medium chain triglycerides and cellulose and soybean oil in people with People Who Are Overweight or Obesity, run by Canadian Center for Functional Medicine at 1 site in Canada.
Trial summary
The purpose of this study is to investigate whether the addition of capsules containing soluble fibre complex emulsified with medium chain triglycerides and taken before with meals will lead to a significant amount of weight loss, reduced glycemic volatility and diminished cardio metabolic risk factors in overweight… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- People Who Are Overweight or Obesity
- What is being tested?
- soluble fibre complex and medium chain triglycerides and cellulose and soybean oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Aug 2009
- Phase
- Phase 2
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 27 - 35 kg/m2
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site
Canadian Center for Functional Medicine
Coquitlam, British Columbia
About this study
Official title: The Effect and Dose-response of Soluble Fibre Blend and Medium Chain Triglycerides (MCT) on Body Composition and Cardiometabolic Risk Factors in Overweight and Obese Adults: a Double-blind, Placebo-controlled Study.
The purpose of this study is to investigate whether the addition of capsules containing soluble fibre complex emulsified with medium chain triglycerides and taken before with meals will lead to a significant amount of weight loss, reduced glycemic volatility and diminished cardio metabolic risk factors in overweight and obese individuals when compared to a placebo control.
We believe that those participants taking 3-6 capsules per day of the treatment capsules over a 14 week period will loose a significant amount of weight compared to the placebo group.
- Conditions
- People Who Are Overweight or Obesity
- Being tested
- soluble fibre complex and medium chain triglycerides, cellulose and soybean oil
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soluble fibre complex and medium chain triglyceridesDietary supplement
cellulose and soybean oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | cellulose and soybean oil Receives: Dietary Supplement: cellulose and soybean oil |
| Intervention | Experimental | soluble fibre complex and medium chain triglycerides Receives: Dietary Supplement: soluble fibre complex and medium chain triglycerides |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: baseline, biweekly and final visit
Secondary outcomes (1)
glycemic volatility and cardio metabolic risk factors
Measured: baseline and final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for People Who Are Overweight or 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Center for Functional Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Timothy Durance, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644098
- Sponsor's protocol ID
- 002
- Status last verified
- Sep 2015
- First submitted
- 24 Mar 2008
- Last updated
- 2 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Dose-response of Soluble Fibre Blend and Medium Chain Triglycerides (MCT) on Body Composition and Cardiometabolic Risk Factors in Overweight and Obese Adults: a Double-blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT00644098
- Acronym / sponsor ID
- 002
- Conditions
- People Who Are Overweight or Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Canadian Center for Functional MedicineUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Mar 2008 (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 investigate whether the addition of capsules containing soluble fibre complex emulsified with medium chain triglycerides and taken before with meals will lead to a significant amount of weight loss, reduced glycemic volatility and diminished cardio metabolic risk factors in overweight and obese individuals when compared to a placebo control.
We believe that those participants taking 3-6 capsules per day of the treatment capsules over a 14 week period will loose a significant amount of weight compared to the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: cellulose and soybean oilcellulose and soybean oil |
| Intervention | Experimental | Dietary Supplement: soluble fibre complex and medium chain triglyceridessoluble fibre complex and medium chain triglycerides |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 27 - 35 kg/m2
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| soluble fibre complex and medium chain triglycerides | Dietary supplement | Intervention |
| cellulose and soybean oil | Dietary supplement | Placebo |
Primary outcome
weight loss
Time frame: baseline, biweekly and final visit
1 secondary outcome
glycemic volatility and cardio metabolic risk factors
Time frame: baseline and final visit
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 2 Oct 2015.
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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.
Timothy Durance, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing soluble fibre complex and medium chain triglycerides and cellulose and soybean oil in people with People Who Are Overweight or Obesity, run by Canadian Center for Functional Medicine at 1 site in Canada.
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 1 inclusion and 1 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 2 Oct 2015. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
weight loss (time frame: baseline, biweekly and final visit). 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 2 Oct 2015.