Studies of the Early Meal Phase in Healthy Individuals - Nutrient Absorption and Gastrointestinal Hormone Secretion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-06-30

Brief Summary

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To investigate gastrointestinal hormone secretions and nutrient absorption during the early meal phase we will recruit 12 healthy young men. They will be equipped with peripheral intravenous catheters for frequent blood sampling. Participants will be screened and acclimatised to the study situation on visit 1. On visit 2 and 3 participants will in random order ingest an oral glucose solution or a standardised liquid mixed meal over 2-3 min.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

12 healthy male individuals will each be studied on two occasions in random order.

* oral glucose tolerance test
* liquid mixed meal test

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Oral glucose tolerance test

Intervention: oral glucose tolerance test (75 gram glucose supplemented with 5g 3-OMG and 1g paracetamol) ingested over 2 min.

Group Type EXPERIMENTAL

Oral glucose tolerance test

Intervention Type OTHER

Oral glucose tolerance test will be carried out with a glucose solution made up of 75g glucose dissolved in 300mL. To the glucose solution will be added 5g 3-OMG and 1g paracetamol 5g 3-OMG

Liquid mixed meal test

Intervention: Standardised liquid mixed meal (supplemented with 1g paracetamol) ingested over 2min

Group Type EXPERIMENTAL

Liquid mixed meal test

Intervention Type OTHER

A standardised liquid mixed meal test will be carried out using a standard liquid mixed meal (fresubin drink supplemented with 1g paracetamol).

Interventions

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Oral glucose tolerance test

Oral glucose tolerance test will be carried out with a glucose solution made up of 75g glucose dissolved in 300mL. To the glucose solution will be added 5g 3-OMG and 1g paracetamol 5g 3-OMG

Intervention Type OTHER

Liquid mixed meal test

A standardised liquid mixed meal test will be carried out using a standard liquid mixed meal (fresubin drink supplemented with 1g paracetamol).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 40years
* Male
* Normal Haemoglobin concentration
* Informed consent

Exclusion Criteria

* Diabetes mellitus
* Family history of diabetes mellitus
* intestinal disease (for example inflammatory bowel disease or malabsorption)
* Family history of inflammatory bowel disease
* Previous intestinal resection (except uncomplicated appendicectomy)
* Body mass index (BMI) \> 25 kg/m2
* Tobacco use
* kidney disease (se-creatinine\> 130 µM and/or albuminuria)
* liver disease (ALAT and/or ASAT \>2 × above normal range)
* Heart disease
* Treatment with drugs
* History of constipation
* Conditions with delayed or accelerated gastric emptying
* Latex or other allergies
* Bleeding diathesis

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes