Glucose MetabolismNCT01801540
The Effects of L-arabinose in a Meal in Healthy Men
A study testing L-arabinose - effect on glucose metabolism in people with Glucose Metabolism, run by University of Copenhagen.
Trial summary
The purpose of this study is to investigate the effect of a meal containing different doses of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and GLP-1) to explain the correlations. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism
- What is being tested?
- L-arabinose - effect on glucose metabolism
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Mar 2011
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male
- normal weight (BMI 18,5-25 kg/m2)
- 18-30 years of age
Who cannot join
- Not healthy,including those with diabetes Mellitus, high bloodpressure, dyslipidemia or a infectious diseases (hepatitis or HIV), gastrointestinal disorders
- Central adipositas (defined as waist circumference > 94 cm for european men)
- Daily intake of vitamins and minerals, 3 months before the trail starts and during the trail.
- elevated alcoholcunsumption(> 21 units af alcohol pr. week)
- take medicine
- Elite athlete with intensive training
- given bloddonation within the last 3 months
- smoking
About this study
Official title: The Effects of L-arabinose in a Meal on Glucose Metabolism in Healthy Men
The purpose of this study is to investigate the effect of a meal containing different doses of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and GLP-1) to explain the correlations.
- Conditions
- Glucose Metabolism
- Being tested
- L-arabinose - effect on glucose metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arabinose - effect on glucose metabolismDietary supplement
L-arabinose is mixed into the dough of the buns and cup cakes
| Study group | Role | What they receive |
|---|---|---|
| 0% arabinose meal sucrose/starch | Experimental | A meal containing a bon with butter and marmalade, a cup cake, The and water Receives: Dietary Supplement: L-arabinose - effect on glucose metabolism |
| 5 % arabinose meal sucrose/starch | Other | A meal containing a bon with butter and marmalade, a cup cake, The and water Receives: Dietary Supplement: L-arabinose - effect on glucose metabolism |
| 10 % arabinose meal sucrose/starch | Other | A meal containing a bon with butter and marmalade, a cup cake, The and water Receives: Dietary Supplement: L-arabinose - effect on glucose metabolism |
| 0 % arabinose meal Starch | Other | A meal containing two bons with butter and cheese, The and water Receives: Dietary Supplement: L-arabinose - effect on glucose metabolism |
| 5 % arabinose meal starch | Other | A meal containing two bons with butter and cheese, The and water Receives: Dietary Supplement: L-arabinose - effect on glucose metabolism |
| 10 % arabinose meal starch | Other | A meal containing two bons with butter and cheese, The and water Receives: Dietary Supplement: L-arabinose - effect on glucose metabolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Level of glucose over time, The AUC, the peak value and time to peak
Measured: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Insulin
Level of insulin over time, the AUC, the peak value and time to peak
Measured: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
C-peptide
Level of c-peptide over time, The AUC, the peak value and time to peak
Measured: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Secondary outcomes (2)
Glucagon
Level of glucagon over time, The AUC, the peak value and time to peak
Measured: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
GLP-1
Level of GLP-1 over time, The AUC, the peak value and time to peak
Measured: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose MetabolismStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
- Investigators
- Jens Rikardt Andersen, MD, lector, Study director, Unit of Nutrition 5711, Rigshospitalet, Blegdamsvej 9, 2100 København Ø
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801540
- Sponsor's protocol ID
- H-2-2010-095
- Status last verified
- Feb 2013
- First submitted
- 27 Feb 2013
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of L-arabinose in a Meal on Glucose Metabolism in Healthy Men
- ClinicalTrials.gov ID
- NCT01801540
- Acronym / sponsor ID
- H-2-2010-095
- Conditions
- Glucose Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Feb 2013 (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 the effect of a meal containing different doses of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and GLP-1) to explain the correlations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0% arabinose meal sucrose/starch | Experimental | Dietary Supplement: L-arabinose - effect on glucose metabolismA meal containing a bon with butter and marmalade, a cup cake, The and water |
| 5 % arabinose meal sucrose/starch | Other | Dietary Supplement: L-arabinose - effect on glucose metabolismA meal containing a bon with butter and marmalade, a cup cake, The and water |
| 10 % arabinose meal sucrose/starch | Other | Dietary Supplement: L-arabinose - effect on glucose metabolismA meal containing a bon with butter and marmalade, a cup cake, The and water |
| 0 % arabinose meal Starch | Other | Dietary Supplement: L-arabinose - effect on glucose metabolismA meal containing two bons with butter and cheese, The and water |
| 5 % arabinose meal starch | Other | Dietary Supplement: L-arabinose - effect on glucose metabolismA meal containing two bons with butter and cheese, The and water |
| 10 % arabinose meal starch | Other | Dietary Supplement: L-arabinose - effect on glucose metabolismA meal containing two bons with butter and cheese, The and water |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male
- normal weight (BMI 18,5-25 kg/m2)
- 18-30 years of age
Key exclusion criteria (8 listed)
- Not healthy,including those with diabetes Mellitus, high bloodpressure, dyslipidemia or a infectious diseases (hepatitis or HIV), gastrointestinal disorders
- Central adipositas (defined as waist circumference > 94 cm for european men)
- Daily intake of vitamins and minerals, 3 months before the trail starts and during the trail.
- elevated alcoholcunsumption(> 21 units af alcohol pr. week)
- take medicine
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 |
|---|---|---|
| L-arabinose - effect on glucose metabolismL-arabinose is mixed into the dough of the buns and cup cakes | Dietary supplement | 0 % arabinose meal Starch, 0% arabinose meal sucrose/starch, 10 % arabinose meal starch, 10 % arabinose meal sucrose/starch, 5 % arabinose meal starch, 5 % arabinose meal sucrose/starch |
Primary outcome
Glucose
Time frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Level of glucose over time, The AUC, the peak value and time to peak
Insulin
Time frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Level of insulin over time, the AUC, the peak value and time to peak
C-peptide
Time frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Level of c-peptide over time, The AUC, the peak value and time to peak
2 secondary outcomes
Glucagon
Time frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
GLP-1
Time frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
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 28 Feb 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.
Jens Rikardt Andersen, MD, lector study director
Unit of Nutrition 5711, Rigshospitalet, Blegdamsvej 9, 2100 København Ø
Questions about this trial
What is this clinical trial studying?
A study testing L-arabinose - effect on glucose metabolism in people with Glucose Metabolism, run by University of Copenhagen.
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 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 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Glucose (time frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min). 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 28 Feb 2013.