Insulin ResistanceM192NCT01957098
The Effects of L-Arabinose and D-xylose on Intestinal Sucrase Activity in Man
A study testing Active comparator: 4% D-xylose, Active comparator: 8% D-xylose and Active comparator: 8% L-arabinose in people with Insulin Resistance, 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 and D-xylose in a sugar-rich drink 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 and D-xylose. 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
- Insulin Resistance
- What is being tested?
- Active comparator: 4% D-xylose, Active comparator: 8% D-xylose and Active comparator: 8% L-arabinose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2006to May 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 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
The purpose of this study is to investigate the effect of L-arabinose and D-xylose in a sugar-rich drink 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 and D-xylose.
Read the detailed description
Based on previous scientific results we hypotesize, that pentoses decreases the demand for insulin in metabolizing a given dose of sucrose.
- Conditions
- Insulin Resistance
- Being tested
- Placebo comparator: 0% pentose, Active comparator: 4% D-xylose, Active comparator: 8% D-xylose, Active comparator: 8% L-arabinose
- Keywords
- L-arabinose, D-xylose, sucrose, glucose, insulin, C-peptide, GLP-1
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo comparator: 0% pentoseDietary supplement
14 healthy subjects participated in a randomized double-blinded cross-over study based on four single tests. Sucrose containing drinks were supplemented with two different doses of D-xylose and in addition one dose of L-arabinose was included for comparison with earlier studies. Blood was collected fasting and for 3-h postprandially. Appetite sensations and energy intake were registered. Gastrointestinal symptoms were monitored for 24 hours
Active comparator: 4% D-xyloseDietary supplement
Active comparator: 8% D-xyloseDietary supplement
Active comparator: 8% L-arabinoseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 0% pentose | Placebo comparator | Pure sucrose without pentoses added. Receives: Dietary Supplement: Placebo comparator: 0% pentose |
| 4% D-xylose | Active comparator | Sucrose drink supplemented with 4% D-xylose Receives: Dietary Supplement: Active comparator: 4% D-xylose |
| 8% D-xylose | Active comparator | Sucrose drink supplemented with 8% D-xylose Receives: Dietary Supplement: Active comparator: 8% D-xylose |
| 8% L-arabinose | Active comparator | Sucrose drink supplemented with 8% L-arabinose Receives: Dietary Supplement: Active comparator: 8% L-arabinose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose, insulin, C-peptide and GLP-1
Level of glucose, insulin, C-peptide and glucagon-like peptide-1 (GLP-1) over time, the area under the curve (AUC), the peak value and time to peak
Measured: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Secondary outcomes (1)
Appetite measurements and energy intake
Appetite measurements: area under/over the curve (AUC/AOC), 3-h mean. Energy intake: the ad libitum energy intake at lunch was registered. VAS was used to asses the palatability (appearance, smell, taste, after-taste and overall palatability) of the ad libitum lunch.
Measured: -15, 30, 60, 90, 120, 150 and 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2006
- Primary completionJan 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danisco
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
- Investigators
- Jens R Andersen, MD,MPA, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957098
- Sponsor's protocol ID
- (KF) 11 324909
- Acronym
- M192
- Status last verified
- Oct 2013
- First submitted
- 8 Aug 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of L-Arabinose and D-xylose on Intestinal Sucrase Activity in Man
- ClinicalTrials.gov ID
- NCT01957098
- Acronym / sponsor ID
- M192 / (KF) 11 324909
- Conditions
- Insulin Resistance
- Keywords
- L-arabinose, D-xylose, sucrose, glucose, insulin, C-peptide, GLP-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Danisco
- Study start
- Oct 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 8 Oct 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 L-arabinose and D-xylose in a sugar-rich drink 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 and D-xylose.
Detailed description
Based on previous scientific results we hypotesize, that pentoses decreases the demand for insulin in metabolizing a given dose of sucrose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0% pentose | Placebo comparator | Dietary Supplement: Placebo comparator: 0% pentosePure sucrose without pentoses added. |
| 4% D-xylose | Active comparator | Dietary Supplement: Active comparator: 4% D-xyloseSucrose drink supplemented with 4% D-xylose |
| 8% D-xylose | Active comparator | Dietary Supplement: Active comparator: 8% D-xyloseSucrose drink supplemented with 8% D-xylose |
| 8% L-arabinose | Active comparator | Dietary Supplement: Active comparator: 8% L-arabinoseSucrose drink supplemented with 8% L-arabinose |
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 |
|---|---|---|
| Placebo comparator: 0% pentose14 healthy subjects participated in a randomized double-blinded cross-over study based on four single tests. Sucrose containing drinks were supplemented with two different doses of D-xylose and in addition one dose of L-arabinose was included for comparison with earlier studies. Blood was collected fasting and for 3-h postprandially. Appetite sensations and energy intake were registered. Gastrointestinal symptoms were monitored for 24 hours | Dietary supplement | 0% pentose |
| Active comparator: 4% D-xylose | Dietary supplement | 4% D-xylose |
| Active comparator: 8% D-xylose | Dietary supplement | 8% D-xylose |
| Active comparator: 8% L-arabinose | Dietary supplement | 8% L-arabinose |
Primary outcome
Blood glucose, insulin, C-peptide and GLP-1
Time frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Level of glucose, insulin, C-peptide and glucagon-like peptide-1 (GLP-1) over time, the area under the curve (AUC), the peak value and time to peak
1 secondary outcome
Appetite measurements and energy intake
Time frame: -15, 30, 60, 90, 120, 150 and 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 8 Oct 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 R Andersen, MD,MPA study chair
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active comparator: 4% D-xylose, Active comparator: 8% D-xylose and Active comparator: 8% L-arabinose in people with Insulin Resistance, 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 8 Oct 2013. 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. 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?
Blood glucose, insulin, C-peptide and GLP-1 (time frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min). 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 8 Oct 2013.