Trial document




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  DRKS00006739

Trial Description

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Title

Measurement of the glycaemic index (GI) of an enteral nutrition formulation in healthy subjects

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Trial Acronym

GCOS-005-CEN

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URL of the Trial

http://Nicht zutreffend

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Brief Summary in Lay Language

In this study the effect of a food for patients with or at risk of malnutrition on the blood sugar level will be measured. The food is a drinking solution (a so called "food for special medical purposes"). Healthy study participants will drink the product. Within 2 hours after intake the blood sugar level will be measured repeatedly (15, 30, 45, 60, 90 and 120 mintes after intake). For each determination of the blood sugar level one droplet of blood will be taken from a fingertip. The blood sugar measurement will be done immediately after taking the droplet by using a special measuring device. As comparison value the blood sugar level after intake of a glucose solution will be determined with the same method. After completion of the study with 12 participants the increase of the blood sugar level following test product intake will be compared with the increase of the blood sugar level following glucose intake. The calculated value is called "glycaemic index". The value provides information about the blood sugar enhancing effect of a food.

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Brief Summary in Scientific Language

The measurement of the glycaemic index of an enteral nutrition formulation is carried out in accordance with the ISO 26642:2010 standard. The product will be compared with a reference food (anhydrous glucose solved in water). The test food will be administered once to the subjects, the reference food will be administered in a repeated-measures design to the subjects via the oral route with each subject serving as his/her own control.

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Organizational Data

  •   DRKS00006739
  •   2014/09/12
  •   [---]*
  •   no
  •   Approved
  •   UREC Registration No: 140806, University Research Ethics Committee, Faculty of Health and Life Sciences, Headington Campus, Gipsy Lane, Oxford OX3 0BP, UK Tel.: 0043 1865 482639 E-Mail:heabbott@brookes.ac.uk
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   None (healthy subjects)
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Interventions/Observational Groups

  •   Single oral intake of drinking solution HV 1058-1. Volume containing 50g glycaemic carbohydrates.
  •   Oral intake of a glucose solution (50g glucose). Intake 3 times on 3 different days.
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Determination of glycaemic index by comparing the blood sugar level enhancement after intake of the test product or a glucose solution within 2 hours after intake. Blood sugar measurement is done -5 and 0 minutes before and 15, 30, 45, 60, 90 and 120 minutes after intake. The blood sugar level measurement is done spectrophotometrically.

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Secondary Outcome

None

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Countries of Recruitment

  •   United Kingdom
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/08/27
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

Healthy subjects who give informed consent to participate in the study

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Exclusion Criteria

Aged < 18 or > 60 years/
Pregnant or lactating/
Body mass index (BMI) ≥ 30kg/m2/
History of diabetes mellitus or fasting blood glucose value > 6.1 mmol/l/
Any known food allergy or intolerance/
Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or influence digestion and absorption of nutrients/
Use steroids, protease inhibitors, amphetamines or antipsychotics/
Use of medications known to affect glucose tolerance (excluding oral contraceptives)

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Addresses

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    • Fresenius Kabi Deutschland GmbH
    • Else-Kröner-Str. 1
    • 61352  Bad Homburg
    • Germany
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    •   06172-686-4908
    •   06172-686-7332
    •   [---]*
    •   [---]*
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    • Fresenius Kabi Deutschland GmbH
    • Mr.  Prof. Dr. med.  John  Stover 
    • Else-Kröner-Str. 1
    • 61352  Bad Homburg
    • Germany
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    • Fresenius Kabi Deutschland GmbH
    • Mr.  Prof. Dr. med.  John  Stover 
    • Else-Kröner-Str. 1
    • 61352  Bad Homburg
    • Germany
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Sources of Monetary or Material Support

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    • Fresenius Kabi Deutschland GmbH
    • Else-Kröner-Str. 1
    • 61352  Bad Homburg
    • Germany
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    •   06172-608-0
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.