Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers
Not Applicable
Completed
- Conditions
- Blood Glucose
- Interventions
- Dietary Supplement: Lactulose liquid 10 gDietary Supplement: Lactulose crystals 10 gDietary Supplement: Lactulose crystals 20 gDietary Supplement: Lactulose liquid 20 gDietary Supplement: Oral glucose 20 gDietary Supplement: Still water
- Registration Number
- NCT02968498
- Lead Sponsor
- Fresenius Kabi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Study arm 1 Lactulose crystals 20 g Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water Study arm 1 Still water Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water Study arm 2 Lactulose liquid 10 g Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water Study arm 2 Lactulose liquid 20 g Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water Study arm 1 Lactulose crystals 10 g Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water Study arm 2 Still water Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water Study arm 2 Oral glucose 20 g Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water Study arm 1 Oral glucose 20 g Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water
- Primary Outcome Measures
Name Time Method Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min)) 0-180 min
- Secondary Outcome Measures
Name Time Method Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min)) 0-180 min Baseline corrected area under curve from 0 to 180 min for blood glucose concentration (AUCbase_c(0-180min)) 0-180 min Area under curve from 0 to 180 min minus baseline\*180min
Maximum blood glucose concentration (Cmax) 0-180 min Relative maximum increase of blood glucose concentration(Max_increase rel) 0-180 min Cmax / baseline value
Adverse events (AEs) After screening till study day 22 (+24 hours) Gastrointestinal tolerability (assessed by subject's questionnaire) 24 hours post-dose Maximum increase of blood glucose concentration (Max_increase) 0-180 min Cmax minus baseline value
Time to reach maximum blood glucose concentration (Tmax) 0-180 min First time to reach baseline again after increase or decrease in blood glucose (Tbaseline) 0-180 min
Trial Locations
- Locations (1)
CRO BioTeSys GmbH
🇩🇪Esslingen, Germany