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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02968498
Other study ID # Lact-001-CEN
Secondary ID
Status Completed
Phase N/A
First received November 16, 2016
Last updated March 2, 2017
Start date November 2016
Est. completion date February 2017

Study information

Verified date March 2017
Source Fresenius Kabi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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.

Locations

Country Name City State
Germany CRO BioTeSys GmbH Esslingen

Sponsors (1)

Lead Sponsor Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min)) 0-180 min
Secondary Maximum blood glucose concentration (Cmax) 0-180 min
Secondary Maximum increase of blood glucose concentration (Max_increase) Cmax minus baseline value 0-180 min
Secondary Relative maximum increase of blood glucose concentration(Max_increase rel) Cmax / baseline value 0-180 min
Secondary Time to reach maximum blood glucose concentration (Tmax) 0-180 min
Secondary First time to reach baseline again after increase or decrease in blood glucose (Tbaseline) 0-180 min
Secondary Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min)) 0-180 min
Secondary 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 0-180 min
Secondary Adverse events (AEs) After screening till study day 22 (+24 hours)
Secondary Gastrointestinal tolerability (assessed by subject's questionnaire) 180 min
Secondary Gastrointestinal tolerability (assessed by subject's questionnaire) 24 hours post-dose
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