HealthyPhase 1/2NCT00631293
Study of the Effect of Lactisole on the Intestinal Glucose Uptake
A Phase 1/2 study testing lactisole in people with Healthy, run by University Ghent at 1 site in Belgium.
Trial summary
Study of the effect of lactisole on glucose uptake Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- lactisole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2008to Apr 2008
- Phase
- Phase 1/2
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subject, between 18 and 50 years
- General good health condition
Who cannot join
- Overweight (Body Mass Index ≥30)
- Metabolic disorders
- History of gastrointestinal disorders
- Regular (daily) intake of medication
- Smoking more than 10 cigarettes/day
- History of drug abuse
Show all 11Show fewer
- Exhaustive (> 3 units/day) alcohol consumption
- Exhaustive (> 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)
- Recent (in the last 14 days) donation of blood
- Recent (in the last 2 days) donation of blood plasma
- Participation in another trial within 4 weeks before the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Effect of Lactisole on the Intestinal Glucose Uptake
Study of the effect of lactisole on glucose uptake
- Conditions
- Healthy
- Being tested
- lactisole, placebo
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactisoleDietary supplement
administration of lactisole followed by placebo
placeboOther
administration of placebo followed by lactisole
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | administration of lactisole Receives: Dietary Supplement: lactisole |
| 2 | Placebo comparator | administration of placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test
Measured: 5 weeks
Secondary outcomes (1)
Differences in blood insulin, glucagon, triglycerides, GIP and GLP-1 in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test, ECG
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University GhentThe 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 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- VIB
- Investigators
- Luc Van Bortel, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631293
- Sponsor's protocol ID
- 2008/103
- Status last verified
- Apr 2009
- First submitted
- 26 Feb 2008
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Lactisole on the Intestinal Glucose Uptake
- ClinicalTrials.gov ID
- NCT00631293
- Acronym / sponsor ID
- 2008/103
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- VIB
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 7 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.
Study of the effect of lactisole on glucose uptake
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: lactisoleadministration of lactisole |
| 2 | Placebo comparator | Other: placeboadministration of placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male subject, between 18 and 50 years
- General good health condition
Key exclusion criteria (11 listed)
- Overweight (Body Mass Index ≥30)
- Metabolic disorders
- History of gastrointestinal disorders
- Regular (daily) intake of medication
- Smoking more than 10 cigarettes/day
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 |
|---|---|---|
| lactisoleadministration of lactisole followed by placebo | Dietary supplement | 1 |
| placeboadministration of placebo followed by lactisole | Other | 2 |
Primary outcome
Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test
Time frame: 5 weeks
1 secondary outcome
Differences in blood insulin, glucagon, triglycerides, GIP and GLP-1 in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test, ECG
Time frame: 5 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 7 Apr 2009.
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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.
Luc Van Bortel, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing lactisole in people with Healthy, run by University Ghent at 1 site in Belgium.
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 11 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 7 Apr 2009. 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 Belgium. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test (time frame: 5 weeks). 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 7 Apr 2009.