The Effects of L-arabinose in a Meal in Healthy Men

NCT01801540 | Completed DMC

• 1 other identifier: H-2-2010-095
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glucose Metabolism

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Glucagon

  -15, 0, 15, 30, 45, 60, 90, 120, 180 min

• GLP-1

  -15, 0, 15, 30, 45, 60, 90, 120, 180 min

Study Arms (6)

0% arabinose meal sucrose/starch

EXPERIMENTAL

A meal containing a bon with butter and marmalade, a cup cake, The and water

Dietary Supplement: L-arabinose - effect on glucose metabolism

5 % arabinose meal sucrose/starch

OTHER

A meal containing a bon with butter and marmalade, a cup cake, The and water

Dietary Supplement: L-arabinose - effect on glucose metabolism

10 % arabinose meal sucrose/starch

OTHER

A meal containing a bon with butter and marmalade, a cup cake, The and water

Dietary Supplement: L-arabinose - effect on glucose metabolism

0 % arabinose meal Starch

OTHER

A meal containing two bons with butter and cheese, The and water

Dietary Supplement: L-arabinose - effect on glucose metabolism

5 % arabinose meal starch

OTHER

A meal containing two bons with butter and cheese, The and water

Dietary Supplement: L-arabinose - effect on glucose metabolism

10 % arabinose meal starch

OTHER

A meal containing two bons with butter and cheese, The and water

Dietary Supplement: L-arabinose - effect on glucose metabolism

Interventions

L-arabinose - effect on glucose metabolism DIETARY_SUPPLEMENT

L-arabinose is mixed into the dough of the buns and cup cakes

0 % arabinose meal Starch; 0% arabinose meal sucrose/starch; 10 % arabinose meal starch; 10 % arabinose meal sucrose/starch; 5 % arabinose meal starch; 5 % arabinose meal sucrose/starch

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male
• normal weight (BMI 18,5-25 kg/m2)
• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Officials

• Jens Rikardt Andersen, MD, lector

  Unit of Nutrition 5711, Rigshospitalet, Blegdamsvej 9, 2100 København Ø

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Med.Sci./Ph.D.

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: February 28, 2013
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 28, 2013

Record last verified: 2013-02