Blood GlucoseNCT02968498
Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers
A study testing Lactulose crystals 10 g, Lactulose crystals 20 g and Lactulose liquid 10 g in people with Blood Glucose, run by Fresenius Kabi at 1 site in Germany.
Trial summary
Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in each study part. The objective of the study is to investigate blood glucose levels after oral intake of defined amounts of lactulose. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Lactulose crystals 10 g, Lactulose crystals 20 g and Lactulose liquid 10 g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Feb 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age: 18-65 years
- Approx. 3-5 bowel movements per week
- Caucasian
- Availability and presence in the trial unit for approx. 4 hours/ week for 4 times in a row with approx. 1 week of washout in between
- Signed informed consent form
Who cannot join
- Known (family) history of diabetes mellitus or use of anti-hyperglycaemic drugs or Insulin
- Clinically relevant renal or hepatic disease, liver enzymes > 10% above reference range
- Fasting blood glucose > 100 mg/dL or HbA1c outside of reference range
- Total cholesterol > 250 mg/dL or triglycerides > 150 mg/dL
- Haemoglobin < 11 g/dL (women); < 12.5 g/dL (men)
- BMI < 19 kg/m² and ≥ 30 kg/m²
Show all 22Show fewer
- Intentional and unintentional weight loss > 5% in the previous 6 months
- Smoker
- Major medical or surgical event requiring hospitalization within the previous 3 months
- Presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits
- Intake of medications known to affect glucose tolerance, e.g., steroids, protease inhibitors or antipsychotics (stable doses of e.g., oral contraceptives, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable)
- Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants, diuretics, thiazides), which in the investigator's opinion would impact volunteer safety
- Hereditary problems of galactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption
- Suspicion of drug abuse
- Abuse of alcoholic drinks, defined as an average daily intake of more than one litre of beer per day or equivalent amount of alcohol in other beverages
- Pregnant or breast feeding women
- Known or suspected allergy to any component of the investigational product(s)
- Known HIV-infection
- Known acute or chronic hepatitis B and C infection
- Blood donation within 4 weeks prior to visit 1 or during the study
- Volunteer unable to co-operate adequately
- Participation in a clinical trial with an investigational product within one month before start of study
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in each study part.
The objective of the study is to investigate blood glucose levels after oral intake of defined amounts of lactulose.
- Conditions
- Blood Glucose
- Being tested
- Lactulose crystals 10 g, Lactulose crystals 20 g, Lactulose liquid 10 g, Lactulose liquid 20 g, Oral glucose 20 g
- Keywords
- Blood glucose level, Oral intake, Lactulose, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactulose crystals 10 gDietary supplement
White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
Lactulose crystals 20 gDietary supplement
White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
Lactulose liquid 10 gDietary supplement
Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
Lactulose liquid 20 gDietary supplement
Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
Oral glucose 20 gDietary supplement
Also called glucose monohydrate
White crystalline powder used as food ingredient. To standardise for 20 g glucose, 22 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
Still waterDietary supplement
Still water will be used. Water from the same source will be also used to dissolve investigational and control products.
| Study group | Role | What they receive |
|---|---|---|
| Study arm 1 | Active comparator | Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water Receives: Dietary Supplement: Lactulose crystals 10 g; Dietary Supplement: Lactulose crystals 20 g; Dietary Supplement: Oral glucose 20 g; Dietary Supplement: Still water |
| Study arm 2 | Active comparator | Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water Receives: Dietary Supplement: Lactulose liquid 10 g; Dietary Supplement: Lactulose liquid 20 g; Dietary Supplement: Oral glucose 20 g; Dietary Supplement: Still water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min))
Measured: 0-180 min
Secondary outcomes (10)
Maximum blood glucose concentration (Cmax)
Measured: 0-180 min
Maximum increase of blood glucose concentration (Max_increase)
Cmax minus baseline value
Measured: 0-180 min
Relative maximum increase of blood glucose concentration(Max_increase rel)
Cmax / baseline value
Measured: 0-180 min
Time to reach maximum blood glucose concentration (Tmax)
Measured: 0-180 min
First time to reach baseline again after increase or decrease in blood glucose (Tbaseline)
Measured: 0-180 min
Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min))
Measured: 0-180 min
Baseline corrected area under curve from 0 to 180 min for blood glucose concentration (AUCbase_c(0-180min))
Area under curve from 0 to 180 min minus baseline*180min
Measured: 0-180 min
Adverse events (AEs)
Measured: After screening till study day 22 (+24 hours)
Gastrointestinal tolerability (assessed by subject's questionnaire)
Measured: 180 min
Gastrointestinal tolerability (assessed by subject's questionnaire)
Measured: 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, MD, Principal investigator, CRO BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968498
- Sponsor's protocol ID
- Lact-001-CEN
- Status last verified
- Mar 2017
- First submitted
- 16 Nov 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02968498
- Acronym / sponsor ID
- Lact-001-CEN
- Conditions
- Blood Glucose
- Keywords
- Blood glucose level, Oral intake, Lactulose, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 18 Nov 2016 (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.
Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in each study part.
The objective of the study is to investigate blood glucose levels after oral intake of defined amounts of lactulose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm 1 | Active comparator | Dietary Supplement: Lactulose crystals 10 g, Dietary Supplement: Lactulose crystals 20 g, Dietary Supplement: Oral glucose 20 g, Dietary Supplement: Still waterLactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water |
| Study arm 2 | Active comparator | Dietary Supplement: Lactulose liquid 10 g, Dietary Supplement: Lactulose liquid 20 g, Dietary Supplement: Oral glucose 20 g, Dietary Supplement: Still waterLactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteers
- Age: 18-65 years
- Approx. 3-5 bowel movements per week
- Caucasian
- Availability and presence in the trial unit for approx. 4 hours/ week for 4 times in a row with approx. 1 week of washout in between
Key exclusion criteria (22 listed)
- Known (family) history of diabetes mellitus or use of anti-hyperglycaemic drugs or Insulin
- Clinically relevant renal or hepatic disease, liver enzymes > 10% above reference range
- Fasting blood glucose > 100 mg/dL or HbA1c outside of reference range
- Total cholesterol > 250 mg/dL or triglycerides > 150 mg/dL
- Haemoglobin < 11 g/dL (women); < 12.5 g/dL (men)
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 |
|---|---|---|
| Lactulose crystals 10 gWhite or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water. | Dietary supplement | Study arm 1 |
| Lactulose crystals 20 gWhite or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water. | Dietary supplement | Study arm 1 |
| Lactulose liquid 10 gClear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water. | Dietary supplement | Study arm 2 |
| Lactulose liquid 20 gClear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water. | Dietary supplement | Study arm 2 |
| Oral glucose 20 gAlso: glucose monohydrateWhite crystalline powder used as food ingredient. To standardise for 20 g glucose, 22 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water. | Dietary supplement | Study arm 1, Study arm 2 |
| Still waterStill water will be used. Water from the same source will be also used to dissolve investigational and control products. | Dietary supplement | Study arm 1, Study arm 2 |
Primary outcome
Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min))
Time frame: 0-180 min
10 secondary outcomes
Maximum blood glucose concentration (Cmax)
Time frame: 0-180 min
Maximum increase of blood glucose concentration (Max_increase)
Time frame: 0-180 min
Relative maximum increase of blood glucose concentration(Max_increase rel)
Time frame: 0-180 min
Time to reach maximum blood glucose concentration (Tmax)
Time frame: 0-180 min
First time to reach baseline again after increase or decrease in blood glucose (Tbaseline)
Time frame: 0-180 min
Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min))
Time frame: 0-180 min
Baseline corrected area under curve from 0 to 180 min for blood glucose concentration (AUCbase_c(0-180min))
Time frame: 0-180 min
Adverse events (AEs)
Time frame: After screening till study day 22 (+24 hours)
Gastrointestinal tolerability (assessed by subject's questionnaire)
Time frame: 180 min
Gastrointestinal tolerability (assessed by subject's questionnaire)
Time frame: 24 hours post-dose
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 3 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Daniel Menzel, MD principal investigator
CRO BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose crystals 10 g, Lactulose crystals 20 g and Lactulose liquid 10 g in people with Blood Glucose, run by Fresenius Kabi at 1 site in Germany.
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 6 inclusion and 22 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 3 Mar 2017. 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 Germany. 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.
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?
Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min)) (time frame: 0-180 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 3 Mar 2017.