Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers
NCT ID: NCT02968498
Last Updated: 2017-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
24 participants
INTERVENTIONAL
2016-11-30
2017-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The objective of the study is to investigate blood glucose levels after oral intake of defined amounts of lactulose.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Enteral Nutrition and Glucose Homeostasis
NCT03012867
Effect of Intravenous 5% Dextrose Infusion During Recovery from Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy
NCT06319144
Glucose Response to a Formula for Patients at Risk of Hypoglycaemia
NCT05676385
Lactic Acidosis and Prior Metformin Treatment
NCT07300293
The Glycaemic Effects of Glucerna® in Critically Ill Patients.
NCT02594865
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study arm 1
Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water
Lactulose crystals 10 g
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 g
White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
Oral glucose 20 g
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 water
Still water will be used. Water from the same source will be also used to dissolve investigational and control products.
Study arm 2
Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water
Lactulose liquid 10 g
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 g
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 g
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 water
Still water will be used. Water from the same source will be also used to dissolve investigational and control products.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lactulose crystals 10 g
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 g
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 g
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 g
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 g
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 water
Still water will be used. Water from the same source will be also used to dissolve investigational and control products.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fresenius Kabi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Menzel, MD
Role: PRINCIPAL_INVESTIGATOR
CRO BioTeSys GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CRO BioTeSys GmbH
Esslingen am Neckar, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Lact-001-CEN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.