Insulin SensitivityEarly Phase 1OPUS-WP3CNCT02412995
The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite
A Early Phase 1 study testing Meal sequence 1-2-3, Meal sequence 1-3-2 and Meal sequence 2-3-1 in people with Insulin Sensitivity and Glucose Intolerance, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia as well as on metabolic profiles were examined in overweight or obese male subjects. The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Glucose Intolerance
- What is being tested?
- Meal sequence 1-2-3, Meal sequence 1-3-2 and Meal sequence 2-3-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Feb 2015
- Phase
- Early 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, male, aged 20-50 years and body mass index (BMI) 25-35 kg/m2
Who cannot join
- Any current or chronic clinical conditions
- Chronic/frequent use of medication
- Smoking
- Blood donation
- High level of strenuous physical activity (>10h/week)
- High habitual alcohol consumption (>14 drinks/week)
- Present or previous drug abuse
- Participation in other human intervention studies, and obesity surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg C, 1958
About this study
Official title: The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite - A Randomised, Controlled, Crossover Study of Danish Berries in Overweight and Obese Male Subjects
The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia as well as on metabolic profiles were examined in overweight or obese male subjects. The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at baseline and several times postprandially. Subjective appetite sensations were recorded at baseline and every 15-20 min until 140 min and a subsequent ad libitum intake was recorded. Urine samples were also collected at baseline and at several time intervals until 24 hours. Blood and urine were subjected to metabolic profiling to investigate potential biomarkers of berry intake.
Read the detailed description
Purpose: Berries and mixed berry products exert acute effects on postprandial glycaemia and insulinemia, but very few berries have been studied, and primarily in normal weight subjects. Sea buckthorn and strawberry are compositionally widely different berries and may likely produce different responses. The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia were examined in overweight or obese male subjects. Subjective appetite sensations and ad libitum intake were also examined. Berries may thus improve health in longer studies; however, accurate assessment of berry intake is still problematic. The discovery of objective biomarkers for intake of berries is therefore important in assessing both intake and compliance. The investigators aimed to identify urinary exposure markers of two very different berries, strawberry and sea buckthorn, in humans.
Methods: The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at t = 0, 30, 45, 60, 90 and 120 min. Subjective appetite sensations were recorded at t = 0, 15, 30, 45, 60, 90, 120 and 140 min and subsequent ad libitum intake was recorded. Statistical differences in all continuous measures were evaluated based on the existence of a meal or a time-meal interaction by repeated measurements analyses or differences in the area under the curve (AUC) for that measure in a linear mixed model. Urine samples were collected on each test day at t=-15min, t=0-1h, t=1-2h, and t=2-24h and were analyzed by untargeted metabolomics. Multivariate analysis was applied to discover markers, followed by molecular fragmentation to ease their chemical identification.
- Conditions
- Insulin Sensitivity, Glucose Intolerance
- Being tested
- Meal sequence 1-2-3, Meal sequence 1-3-2, Meal sequence 2-3-1, Meal sequence 2-1-3, Meal sequence 3-1-2
- Keywords
- sea buckthorn, strawberry, glucose response, satiety, metabolomics, intake biomarker
- Medical subject headings
- Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal sequence 1-2-3Other
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
Meal sequence 1-3-2Other
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
Meal sequence 2-3-1Other
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
Meal sequence 2-1-3Other
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
Meal sequence 3-1-2Other
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
Meal sequence 3-2-1Other
The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| Meal sequence 1-2-3 | Experimental | The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 1-2-3 Receives: Other: Meal sequence 1-2-3 |
| Meal sequence 1-3-2 | Experimental | The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 1-3-2 Receives: Other: Meal sequence 1-3-2 |
| Meal sequence 2-3-1 | Experimental | The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 2-3-1 Receives: Other: Meal sequence 2-3-1 |
| Meal sequence 2-1-3 | Experimental | The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 2-1-3 Receives: Other: Meal sequence 2-1-3 |
| Meal sequence 3-1-2 | Experimental | The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 3-1-2 Receives: Other: Meal sequence 3-1-2 |
| Meal sequence 3-2-1 | Experimental | The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 3-2-1 Receives: Other: Meal sequence 3-2-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemia Area under the plasma glucose concentration curve, concentration curve.
Area under the plasma glucose concentration curve, concentration curve.
Measured: postprandially 0-120min
Secondary outcomes (8)
Insulin response Area under the plasma insulin concentration curve
Area under the plasma insulin concentration curve
Measured: postprandially 0-120min
Appetite scores (visual analogue scale)
Measured on a 100 mm visual analogue scale spanning the sensation from minimum to maximum on the following: hunger, satiety, fullness, perceived prospective food intake, thirst, well-being, and desire for something sweet.
Measured: postprandially 0-140min
urine metabolic profile
Urine samples were collected on each test day at t=-15min, t=0-1h, t=1-2h, and t=2-24h and were analyzed by untargeted metabolomics (UPLC-QTOF)
Measured: 0-24 hrs
plasma metabolic profile (metabolic profiling by UPLC-QTOF)
Blood samples were drawn at t = -20 (baseline), 30, 45, 60, 90 and 120 min on each test day and subjected to untargeted metabolic profiling by UPLC-QTOF
Measured: 0-120min
Meal perception VAS questionnaire
A VAS questionnaire concerning meal perception with ratings for taste (poor/good), smell (not appetising/appetising), appearance (not appetising/appetising), undertaste (none/much), and overall impression (not appetising/appetising).
Measured: postprandially at 30min and 140 min
Incremental area under the plasma glucose concentration curve
The area under the initial part of the glucose plasma curve from the volunteer has ingested the sugar solution until 60 min later
Measured: postprandially, 0-30 and 0-60min
Glycemic profile (calculated as the time in minutes during which the blood glucose concentration is above baseline concentration divided by the incremental peak value of blood glucose)
Gycemic profile((calculated as the time in minutes during which the blood glucose concentration is above baseline concentration divided by the incremental peak value of blood glucose)
Measured: 0-120 min
Incremental insulin response Incremental area under the plasma insulin concentration curve.
Incremental area under the plasma insulin concentration curve.
Measured: Postprandially 0-30 and 0-60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startOct 2012
- Primary completionNov 2012
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Nordea-fonden
- Responsible party
- Principal investigator, Professor Lars Ove Dragsted, University of Copenhagen
- Investigators
- Lars O Dragsted, Ph.D., Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412995
- Sponsor's protocol ID
- M208
- Acronym
- OPUS-WP3C
- Status last verified
- Apr 2015
- First submitted
- 8 Feb 2015
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sea Buckthorn and Strawberry on Postprandial Glycaemia, Insulinemia and Appetite - A Randomised, Controlled, Crossover Study of Danish Berries in Overweight and Obese Male Subjects
- ClinicalTrials.gov ID
- NCT02412995
- Acronym / sponsor ID
- OPUS-WP3C / M208
- Conditions
- Insulin Sensitivity, Glucose Intolerance
- Keywords
- sea buckthorn, strawberry, glucose response, satiety, metabolomics, intake biomarker
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Nordea-fonden
- Study start
- Oct 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 9 Apr 2015 (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 effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia as well as on metabolic profiles were examined in overweight or obese male subjects. The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at baseline and several times postprandially. Subjective appetite sensations were recorded at baseline and every 15-20 min until 140 min and a subsequent ad libitum intake was recorded. Urine samples were also collected at baseline and at several time intervals until 24 hours. Blood and urine were subjected to metabolic profiling to investigate potential biomarkers of berry intake.
Detailed description
Purpose: Berries and mixed berry products exert acute effects on postprandial glycaemia and insulinemia, but very few berries have been studied, and primarily in normal weight subjects. Sea buckthorn and strawberry are compositionally widely different berries and may likely produce different responses. The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia were examined in overweight or obese male subjects. Subjective appetite sensations and ad libitum intake were also examined. Berries may thus improve health in longer studies; however, accurate assessment of berry intake is still problematic. The discovery of objective biomarkers for intake of berries is therefore important in assessing both intake and compliance. The investigators aimed to identify urinary exposure markers of two very different berries, strawberry and sea buckthorn, in humans.
Methods: The study was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test meals contained either sea buckthorn, strawberry or no berries and added sucrose to match with respect to sucrose content. Blood samples were collected at t = 0, 30, 45, 60, 90 and 120 min. Subjective appetite sensations were recorded at t = 0, 15, 30, 45, 60, 90, 120 and 140 min and subsequent ad libitum intake was recorded. Statistical differences in all continuous measures were evaluated based on the existence of a meal or a time-meal interaction by repeated measurements analyses or differences in the area under the curve (AUC) for that measure in a linear mixed model. Urine samples were collected on each test day at t=-15min, t=0-1h, t=1-2h, and t=2-24h and were analyzed by untargeted metabolomics. Multivariate analysis was applied to discover markers, followed by molecular fragmentation to ease their chemical identification.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Meal sequence 1-2-3 | Experimental | Other: Meal sequence 1-2-3The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 1-2-3 |
| Meal sequence 1-3-2 | Experimental | Other: Meal sequence 1-3-2The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 1-3-2 |
| Meal sequence 2-3-1 | Experimental | Other: Meal sequence 2-3-1The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 2-3-1 |
| Meal sequence 2-1-3 | Experimental | Other: Meal sequence 2-1-3The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 2-1-3 |
| Meal sequence 3-1-2 | Experimental | Other: Meal sequence 3-1-2The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 3-1-2 |
| Meal sequence 3-2-1 | Experimental | Other: Meal sequence 3-2-1The three meals, sea buckthorn puree, strawberry puree, or placebo (sugar drink) were allocated a number (1-3) in a blinded fashion and given to the participants in the order 3-2-1 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, male, aged 20-50 years and body mass index (BMI) 25-35 kg/m2
Key exclusion criteria (8 listed)
- Any current or chronic clinical conditions
- Chronic/frequent use of medication
- Smoking
- Blood donation
- High level of strenuous physical activity (>10h/week)
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 |
|---|---|---|
| Meal sequence 1-2-3The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water. | Other | Meal sequence 1-2-3 |
| Meal sequence 1-3-2The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water. | Other | Meal sequence 1-3-2 |
| Meal sequence 2-3-1The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water. | Other | Meal sequence 2-3-1 |
| Meal sequence 2-1-3The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water. | Other | Meal sequence 2-1-3 |
| Meal sequence 3-1-2The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water. | Other | Meal sequence 3-1-2 |
| Meal sequence 3-2-1The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water. | Other | Meal sequence 3-2-1 |
Primary outcome
Glycemia Area under the plasma glucose concentration curve, concentration curve.
Time frame: postprandially 0-120min
Area under the plasma glucose concentration curve, concentration curve.
8 secondary outcomes
Insulin response Area under the plasma insulin concentration curve
Time frame: postprandially 0-120min
Appetite scores (visual analogue scale)
Time frame: postprandially 0-140min
urine metabolic profile
Time frame: 0-24 hrs
plasma metabolic profile (metabolic profiling by UPLC-QTOF)
Time frame: 0-120min
Meal perception VAS questionnaire
Time frame: postprandially at 30min and 140 min
Incremental area under the plasma glucose concentration curve
Time frame: postprandially, 0-30 and 0-60min
Glycemic profile (calculated as the time in minutes during which the blood glucose concentration is above baseline concentration divided by the incremental peak value of blood glucose)
Time frame: 0-120 min
Incremental insulin response Incremental area under the plasma insulin concentration curve.
Time frame: Postprandially 0-30 and 0-60 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 9 Apr 2015.
- Homepage for integrated studyLink provided by the sponsor.
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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.
Lars O Dragsted, Ph.D. principal investigator
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 Early Phase 1 study testing Meal sequence 1-2-3, Meal sequence 1-3-2 and Meal sequence 2-3-1 in people with Insulin Sensitivity and Glucose Intolerance, 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 1 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 9 Apr 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Glycemia Area under the plasma glucose concentration curve, concentration curve. (time frame: postprandially 0-120min). 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 9 Apr 2015.