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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01801540
Other study ID # H-2-2010-095
Secondary ID
Status Completed
Phase N/A
First received February 27, 2013
Last updated February 27, 2013
Start date December 2010
Est. completion date March 2011

Study information

Verified date February 2013
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of a meal containing different doses of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and GLP-1) to explain the correlations.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Healthy male

- normal weight (BMI 18,5-25 kg/m2)

- 18-30 years of age

Exclusion Criteria:

- Not healthy,including those with diabetes Mellitus, high bloodpressure, dyslipidemia or a infectious diseases (hepatitis or HIV), gastrointestinal disorders

- Central adipositas (defined as waist circumference > 94 cm for european men)

- Daily intake of vitamins and minerals, 3 months before the trail starts and during the trail.

- elevated alcoholcunsumption(> 21 units af alcohol pr. week)

- take medicine

- Elite athlete with intensive training

- given bloddonation within the last 3 months

- smoking

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
L-arabinose - effect on glucose metabolism
L-arabinose is mixed into the dough of the buns and cup cakes

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Copenhagen

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose Level of glucose over time, The AUC, the peak value and time to peak -15, 0, 15, 30, 45, 60, 90, 120, 180 min No
Primary Insulin Level of insulin over time, the AUC, the peak value and time to peak -15, 0, 15, 30, 45, 60, 90, 120, 180 min No
Primary C-peptide Level of c-peptide over time, The AUC, the peak value and time to peak -15, 0, 15, 30, 45, 60, 90, 120, 180 min No
Secondary Glucagon Level of glucagon over time, The AUC, the peak value and time to peak -15, 0, 15, 30, 45, 60, 90, 120, 180 min No
Secondary GLP-1 Level of GLP-1 over time, The AUC, the peak value and time to peak -15, 0, 15, 30, 45, 60, 90, 120, 180 min No
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