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The effect of L-arabinose on glycaemic and insulinemic response in a liquid and a solid product.


- candidate number24502
- NTR NumberNTR5929
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jun-2016
- Secondary IDsABR: NL55974.081.15 METC-WU 15/33
- Public TitleThe effect of L-arabinose on glycaemic and insulinemic response in a liquid and a solid product.
- Scientific TitleThe effect of L-arabinose on glycaemic and insulinemic response in a liquid and a solid product.
- ACRONYMAra2-study
- hypothesisConsumption of foods containing L-arabinose will improve glycaemic and insulinemic response.
- Healt Condition(s) or Problem(s) studiedEating behaviour, Obesity, Overweight, Metabolic health
- Inclusion criteria 18-35 Years old while signing the informed consent
Good Dutch speaking, writing, understanding
Healthy: as judged by the subject
Stable body weight, i.e. no reported weight loss or weight gain of > 5 kg in the two months prior to the screening session
Normal fasting glucose concentration <6.1 mmol/L, measured by finger prick
Normal hemoglobine (Hb) concentration >8.5 mmol/L for men and >7.5 mmol/L for females, measured by finger prick
- Exclusion criteria Women being pregnant or lactating
Allergy, intolerance or oversensitivity for food products
Having reported gastro-intestinal problems
Having a history of medical or surgical events that may affect the study outcome
Medical drug use (except for contraceptives) that may affect the study outcome
Current antibiotics usage or in the two months prior to the screening session
Not willing to eat or drink the test products
Use of dietary supplements that may affect the study outcome
Currently using a slimming or medically prescribed diet or having used one in the two months prior to the screening session
Excessive alcohol consumption (>21 glasses/week on average)
Planning to change physical activity pattern during the study period
Having blood vessels that are too difficult for inserting a cannula, as judged by the study nurse
Recent blood donation (<1 month prior to Day 1 of the study)
Planning to donate blood as a blood donor during the study
Not having a general practitioner
Being an employee or student doing a thesis or internship of Wageningen University, department of Human Nutrition
Current participation in other research
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 24-mei-2016
- planned closingdate1-jul-2016
- Target number of participants18
- Interventions1) Sugar drink; 2) L-arabinose and Sugar drink; 3) L-arabinose drink; 4) Sugar clusters; 5) L-arabinose clusters low dose; 6) L-arabinose clusters high dose
- Primary outcomeblood glucose and insulin levels
- Secondary outcomeappetite feelings, GLP-1 levels, ad libitum food intake, acceptability of the products, L-arabinose levels, excretion of L-arabinose
- TimepointsEvery subject will visit the research site 8 times:
1: For an information meeting;
2: For a screening meeting;
3: 6 test sessions
A. Blood collection and appetite feelings by VAS questionnaire: baseline, 15, 30, 45, 60, 90, 120, 180 minutes after start of the treatment;
B. Ad libitum test meal at 190 minutes after start of the treatment;
C. Gastro-intestinal comfort at baseline, 3, 6 and 9 hours after start of the treatment.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Korrie Pol
- CONTACT for SCIENTIFIC QUERIES Monica Mars
- Sponsor/Initiator Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
EU grant
- Publications
- Brief summaryL-arabinose is a pentose which is naturally present in plants. L-arabinose can act as a sugar substitute in many foods, among which drinks and cereal clusters.
The main objective is to determine and compare the effect of partly substituting sucrose by L-arabinose in a sucrose solution and in a cereal cluster on glycaemic responses and insulinemic responses in healthy humans. Secondary objectives are: To determine and compare the effect of partly substituting sucrose by L-arabinose in a sucrose solution and in a cereal cluster on: 1) the absorption and excretion of L-arabinose. 2) plasma GLP-1 concentration. 3) subsequent ad libitum energy intake. 4) appetite feelings. 5) the acceptability of the treatments as measured by gastro-intestinal comfort.
The study is a randomized within blocks, cross-over study. The liquids treatment is open labelled, for the cereal clusters the study is double-blind. All subjects will receive six interventions in an order randomized within solutions and cereal clusters. The food products will be consumed in fasting state as a breakfast. All control products contain 50g available carbohydrates. In the drinks, one treatment 30% (i.e. 15g) of the sucrose will be replaced by L-arabinose, the other treatment 15g L-arabinose without sucrose will be added to water; in the cereal clusters 10% and 15% sucrose will be replaced by L-arabinose.
Eighteen healthy adults between 18-35y old will be included. The food products will be consumed in fasting state as a breakfast. All control products contain 50g available carbohydrates.
- Main changes (audit trail)
- RECORD17-jun-2016 - 7-sep-2016


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