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…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Glycaemic response, measured as iAUC, peak and time-to-peak of blood glucose
during 180 minutes;
2) Insulinemic response, measured as AUC, peak and time-to-peak of plasma
insulin during 180 minutes;
Secondary outcome
3) L-arabinose in plasma;
4) GLP-1 in plasma;
5) Subsequent ad libitum food intake, measured as total energy and
macronutrient intake;
6) Appetite feelings, measured by a VAS-questionnaire at multiple time points
during 180 minutes;
7) Gastro-intestinal comfort using a questionnaire;
8) Study diary;
9) L-arabinose in urine.
Background summary
L-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.
Study objective
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.
Study design
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.
Intervention
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.
Study burden and risks
The intervention is non-therapeutic to the subject. The risk associated with
participation is negligible and the burden can be considered as moderate.
L-arabinose is a pentose. L-arabinose is present in a wide range of plants, and
form a part of the daily diet of most of the world*s population. The safety of
L-arabinose is not yet evaluated by legal authorities and it has not yet been
classified as GRAS in the USA and as novel food ingredient in the EU. However,
in Japan and the USA these compounds are used in foods. Also in Europe research
has been done to these compounds in humans.
After signing the informed consent the following measurements and
questionnaires will be taken: General questionnaire, health questionnaire and
Dutch Eating Behaviour Questionnaire. At screening the following measurements
will be taken: height, body weight, fasting blood via finger prick to determine
glucose, and Hb concentration. On the evenings before the experimental test
days, subjects will consume an evening meal distributed by the study team.
During the test day subjects need to come in a fasting state to the University.
Then, 8 blood samples via a catheter and appetite questionnaires will be
collected in 180 minutes, subsequent ad libitum lunch intake, as well as a
gastro-intestinal comfort questionnaire, and an evaluation questionnaire to ask
which treatment they thought they had. Additionally, subjects will collect
urine for 24h. The total study lasts for six weeks. So, including the
information meeting, screening and returning urine the subjects need to visit
the University fourteen times.
Bomenweg 2
Wageningen 6703 HD
NL
Bomenweg 2
Wageningen 6703 HD
NL
Listed location countries
Age
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 a history of medical or surgical events that may affect the study outcome
• Having reported gastro-intestinal problems
• Medical drug use 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 a student doing a thesis or internship at the department of Human Nutrition
• Current participation in other research
Design
Recruitment
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL55974.081.15 |