Blood GlucosePhase 1NCT00302302
The Effects of L-arabinose on Intestinal Sucrase Activity in Man
A Phase 1 study testing L-arabinose in people with Blood Glucose, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effect of L-arabinose in a sugar-rich meal on intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and insulin, and selected intestinal hormonal responses to increasing doses of L-arabinose. 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
- Blood Glucose
- What is being tested?
- L-arabinose
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2005to Jan 2006
- Phase
- Phase 1
- 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 males
- BMI between 18.4-25 kg/m2
- age between 18 and 30
Who cannot join
- donation of blood 3 months before or during the study
- gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease (HIV or hepatitis)
- smoking
- consumption of more than 21 alcoholic drinks/week
- elite athletes
- on medication
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Human Nutrition, The Royal Veterinary and Agricultural University
Frederiksberg, DK-1958
About this study
Official title: The Effects of Increasing Doses of L-arabinose in a Sucrose Rich Meal on Intestinal Sucrase Activity in Man
The purpose of this study is to investigate the effect of L-arabinose in a sugar-rich meal on intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and insulin, and selected intestinal hormonal responses to increasing doses of L-arabinose.
Read the detailed description
Background:
The intake of common table sugar (sucrose) in the industrialised countries is relatively high. In Denmark the daily intake of sugar is in the range of 30-40 g/d exclusive the intake of sugar containing drinks. The health consequences of this relatively high sugar intake are heavily debated in the media. One of the arguments is that a high sugar intake may be one of the factors involved in the development of the metabolic syndrome, including overweight, increased blood glucose and insulin levels as well as impaired insulin action.
L-arabinose is widely distributed in plants and is a common component in plant cell walls in maize, wheat, rye, rice, plant gums etc. The isolated 5-carbon sugar has been shown to suppress the increase of blood glucose and plasma insulin after ingestion of sucrose in rats by inhibition of sucrase activity. In vitro studies on Caco-2 cells indicate that L-arabinose is a potent inhibitor on sucrase activity, possibly in a non-competitive way.
Potential nutritional advantages of consuming L-arabinose in combination with sucrose may therefore be a delayed digestion of sucrose and a lower absorption of glucose, resulting in both lower blood glucose and insulin levels. A delayed digestion of sucrose will reduce the energy utilisation with the potential of reducing weight gain in human subjects.
Methods:
This dose-response study with 14 healthy male volunteers has a randomised cross-over design based on four single "meals" separated by one week wash-out periods. Sugar rich drinks supplemented with different doses of L-arabinose will be tested with respect to postprandial blood glucose, insulin, triglyceride, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1). Postprandial blood samples will be taken every 15 to 30 min for 180 min. Appetite sensations will be measured every 30 min during the experiment. After 180 minutes a lunch will be served and energy intake (EI) will be registered.
- Conditions
- Blood Glucose
- Being tested
- L-arabinose
- Keywords
- Blood glucose, Insulin, Triglyceride, GIP, GLP-1, L-arabinose, Appetite, Energy intake
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arabinoseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose, insulin, triglycerides, GIP and GLP-1
Blood samples 2 hours after a test meal
Measured: 2 hours
Secondary outcomes (1)
Appetite measurements and energy intake
measured after a test meal
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startSep 2005
- Primary completionNov 2005
- Study completionJan 2006
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 Blood GlucoseStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danisco
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Klaus Bukhave, MSc, MScD, Principal investigator, Institute of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302302
- Sponsor's protocol ID
- (KF) 01 270121
- Other IDs
- M181
- Status last verified
- Feb 2014
- First submitted
- 21 Sep 2005
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Krog-Mikkelsen I, Hels O, Tetens I, Holst JJ, Andersen JR, Bukhave K. The effects of L-arabinose on intestinal sucrase activity: dose-response studies in vitro and in humans. Am J Clin Nutr. 2011 Aug;94(2):472-8. doi: 10.3945/ajcn.111.014225. Epub 2011 Jun 15.
PubMed 21677059
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Increasing Doses of L-arabinose in a Sucrose Rich Meal on Intestinal Sucrase Activity in Man
- ClinicalTrials.gov ID
- NCT00302302
- Acronym / sponsor ID
- (KF) 01 270121
- Conditions
- Blood Glucose
- Keywords
- Blood glucose, Insulin, Triglyceride, GIP, GLP-1, L-arabinose, Appetite, Energy intake
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Danisco
- Study start
- Sep 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 14 Mar 2006 (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 L-arabinose in a sugar-rich meal on intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and insulin, and selected intestinal hormonal responses to increasing doses of L-arabinose.
Detailed description
Background:
The intake of common table sugar (sucrose) in the industrialised countries is relatively high. In Denmark the daily intake of sugar is in the range of 30-40 g/d exclusive the intake of sugar containing drinks. The health consequences of this relatively high sugar intake are heavily debated in the media. One of the arguments is that a high sugar intake may be one of the factors involved in the development of the metabolic syndrome, including overweight, increased blood glucose and insulin levels as well as impaired insulin action.
L-arabinose is widely distributed in plants and is a common component in plant cell walls in maize, wheat, rye, rice, plant gums etc. The isolated 5-carbon sugar has been shown to suppress the increase of blood glucose and plasma insulin after ingestion of sucrose in rats by inhibition of sucrase activity. In vitro studies on Caco-2 cells indicate that L-arabinose is a potent inhibitor on sucrase activity, possibly in a non-competitive way.
Potential nutritional advantages of consuming L-arabinose in combination with sucrose may therefore be a delayed digestion of sucrose and a lower absorption of glucose, resulting in both lower blood glucose and insulin levels. A delayed digestion of sucrose will reduce the energy utilisation with the potential of reducing weight gain in human subjects.
Methods:
This dose-response study with 14 healthy male volunteers has a randomised cross-over design based on four single "meals" separated by one week wash-out periods. Sugar rich drinks supplemented with different doses of L-arabinose will be tested with respect to postprandial blood glucose, insulin, triglyceride, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1). Postprandial blood samples will be taken every 15 to 30 min for 180 min. Appetite sensations will be measured every 30 min during the experiment. After 180 minutes a lunch will be served and energy intake (EI) will be registered.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy males
- BMI between 18.4-25 kg/m2
- age between 18 and 30
Key exclusion criteria (6 listed)
- donation of blood 3 months before or during the study
- gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease (HIV or hepatitis)
- smoking
- consumption of more than 21 alcoholic drinks/week
- elite athletes
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 | Drug | – |
Primary outcome
Plasma glucose, insulin, triglycerides, GIP and GLP-1
Time frame: 2 hours
Blood samples 2 hours after a test meal
1 secondary outcome
Appetite measurements and energy intake
Time frame: 10 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 26 Feb 2014.
- Derived from this study: PubMed 21677059Krog-Mikkelsen I, Hels O, Tetens I, Holst JJ, Andersen JR, Bukhave K. The effects of L-arabinose on intestinal sucrase activity: dose-response studies in vitro and in humans. Am J Clin Nutr. 2011 Aug;94(2):472-8. doi: 10.3945/ajcn.111.014225. Epub 2011 Jun 15.
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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.
Klaus Bukhave, MSc, MScD principal investigator
Institute of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-arabinose in people with Blood Glucose, run by University of Copenhagen at 1 site in Denmark.
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 26 Feb 2014. 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 Denmark. 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.
What does this 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.
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?
Plasma glucose, insulin, triglycerides, GIP and GLP-1 (time frame: 2 hours). 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 NCT00302302, 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 26 Feb 2014.