The Effects of L-Arabinose on Intestinal Sucrase Activity in Man
Recruitment status was Active, not recruiting
|First Received Date ICMJE||September 21, 2005|
|Last Updated Date||January 20, 2009|
|Start Date ICMJE||September 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Blood glucose, insulin, triglycerides, GIP and GLP-1|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00302302 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Appetite measurements and energy intake|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Effects of L-Arabinose on Intestinal Sucrase Activity in Man|
|Official Title ICMJE||The Effects of Increasing Doses of L-Arabinose in a Sucrose Rich Meal on Intestinal Sucrase Activity in Man|
The purpose of this study is to investigate the effect of L-arabinose in a sugar-rich meal on intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and insulin, and selected intestinal hormonal responses to increasing doses of L-arabinose.
The intake of common table sugar (sucrose) in the industrialised countries is relatively high. In Denmark the daily intake of sugar is in the range of 30-40 g/d exclusive the intake of sugar containing drinks. The health consequences of this relatively high sugar intake are heavily debated in the media. One of the arguments is that a high sugar intake may be one of the factors involved in the development of the metabolic syndrome, including overweight, increased blood glucose and insulin levels as well as impaired insulin action.
L-arabinose is widely distributed in plants and is a common component in plant cell walls in maize, wheat, rye, rice, plant gums etc. The isolated 5-carbon sugar has been shown to suppress the increase of blood glucose and plasma insulin after ingestion of sucrose in rats by inhibition of sucrase activity. In vitro studies on Caco-2 cells indicate that L-arabinose is a potent inhibitor on sucrase activity, possibly in a non-competitive way.
Potential nutritional advantages of consuming L-arabinose in combination with sucrose may therefore be a delayed digestion of sucrose and a lower absorption of glucose, resulting in both lower blood glucose and insulin levels. A delayed digestion of sucrose will reduce the energy utilisation with the potential of reducing weight gain in human subjects.
This dose-response study with 14 healthy male volunteers has a randomised cross-over design based on four single "meals" separated by one week wash-out periods. Sugar rich drinks supplemented with different doses of L-arabinose will be tested with respect to postprandial blood glucose, insulin, triglyceride, GIP and GLP-1. Postprandial blood samples will be taken every 15 to 30 min for 180 min. Appetite sensations will be measured every 30 min during the experiment. After 180 minutes an ad libitum lunch will be served and EI will be registered.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Condition ICMJE||Blood Glucose|
|Intervention ICMJE||Drug: L-arabinose|
|Study Arm (s)||Not Provided|
|Publications *||Krog-Mikkelsen I, Hels O, Tetens I, Holst JJ, Andersen JR, Bukhave K. The effects of L-arabinose on intestinal sucrase activity: dose-response studies in vitro and in humans. Am J Clin Nutr. 2011 Aug;94(2):472-8. Epub 2011 Jun 15.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Completion Date||November 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 30 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Denmark|
|NCT Number ICMJE||NCT00302302|
|Other Study ID Numbers ICMJE||(KF) 01 270121, M181|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Copenhagen|
|Information Provided By||University of Copenhagen|
|Verification Date||November 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP