Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Blood Glucose
• Intervention / Treatment: Dietary supplement: Lactulose crystals 10 g; Dietary supplement: Lactulose crystals 20 g; Dietary supplement: Oral glucose 20 g; Dietary supplement: Still water; Dietary supplement: Lactulose liquid 10 g; Dietary supplement: Lactulose liquid 20 g

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • CRO BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Study arm 1; Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water	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.; Dietary supplement: 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.; Dietary supplement: 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.; Other Names: glucose monohydrate; Dietary supplement: Still water; Still water will be used. Water from the same source will be also used to dissolve investigational and control products.
ACTIVE_COMPARATOR: Study arm 2; Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water	Dietary supplement: 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.; Other Names: glucose monohydrate; Dietary supplement: Still water; Still water will be used. Water from the same source will be also used to dissolve investigational and control products.; Dietary supplement: 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.; Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min))	0-180 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum blood glucose concentration (Cmax)		0-180 min
Maximum increase of blood glucose concentration (Max_increase)	Cmax minus baseline value	0-180 min
Relative maximum increase of blood glucose concentration(Max_increase rel)	Cmax / baseline value	0-180 min
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
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))	Area under curve from 0 to 180 min minus baseline*180min	0-180 min
Adverse events (AEs)		After screening till study day 22 (+24 hours)
Gastrointestinal tolerability (assessed by subject's questionnaire)		180 min
Gastrointestinal tolerability (assessed by subject's questionnaire)		24 hours post-dose

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Principal Investigator: Daniel Menzel, MD, CRO BioTeSys GmbH

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (ESTIMATE): November 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Healthy volunteers; Oral intake; Lactulose; Blood glucose level
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Lactulose; Methamphetamine
• Other Study ID Numbers: Lact-001-CEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO