Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers

NCT02968498 | Completed

• 1 other identifier: Lact-001-CEN
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Glucose

Keywords

Blood glucose level; Oral intake; Lactulose; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min))

  0-180 min

Secondary Outcomes (10)

• Maximum blood glucose concentration (Cmax)

  0-180 min

• Maximum increase of blood glucose concentration (Max_increase)

  0-180 min

• Relative maximum increase of blood glucose concentration(Max_increase rel)

  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

Study Arms (2)

Study arm 1

ACTIVE COMPARATOR

Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water

Dietary Supplement: Lactulose crystals 10 g; Dietary Supplement: Lactulose crystals 20 g; Dietary Supplement: Oral glucose 20 g; Dietary Supplement: Still water

Study arm 2

ACTIVE COMPARATOR

Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water

Dietary Supplement: Lactulose liquid 10 g; Dietary Supplement: Lactulose liquid 20 g; Dietary Supplement: Oral glucose 20 g; Dietary Supplement: Still water

Interventions

Lactulose crystals 10 g DIETARY_SUPPLEMENT

White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.

Study arm 1

Lactulose crystals 20 g DIETARY_SUPPLEMENT

White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.

Study arm 1

Lactulose liquid 10 g DIETARY_SUPPLEMENT

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.

Study arm 2

Lactulose liquid 20 g DIETARY_SUPPLEMENT

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.

Study arm 2

Oral glucose 20 g DIETARY_SUPPLEMENT

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.

Also known as: glucose monohydrate

Study arm 1; Study arm 2

Still water DIETARY_SUPPLEMENT

Still water will be used. Water from the same source will be also used to dissolve investigational and control products.

Study arm 1; Study arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (1)

CRO BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Daniel Menzel, MD

  CRO BioTeSys GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)