Blood Glucose
Conditions
Keywords
Blood glucose level, Oral intake, Lactulose, Healthy volunteers
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.
Interventions
DIETARY_SUPPLEMENTLactulose 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.
DIETARY_SUPPLEMENTLactulose 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.
DIETARY_SUPPLEMENTLactulose 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.
DIETARY_SUPPLEMENTLactulose 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.
DIETARY_SUPPLEMENTOral 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.
DIETARY_SUPPLEMENTStill water
Still water will be used. Water from the same source will be also used to dissolve investigational and control products.
Sponsors
Fresenius Kabi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min)) | 0-180 min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum increase of blood glucose concentration (Max_increase) | 0-180 min | Cmax minus baseline value |
| Relative maximum increase of blood glucose concentration(Max_increase rel) | 0-180 min | Cmax / 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 | — |
| Maximum blood glucose concentration (Cmax) | 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 |
| Adverse events (AEs) | After screening till study day 22 (+24 hours) | — |
| Gastrointestinal tolerability (assessed by subject's questionnaire) | 180 min | — |
| Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min)) | 0-180 min | — |
Countries
Germany
Outcome results
None listed