Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers

Blood Glucose Clinical Trial

Official title:

Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968498
• Other study ID #: Lact-001-CEN
• 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
• 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

Related Conditions & MeSH terms

• Blood Glucose

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