The primary objective is to quantify and compare the effect of added arabinose to sucrose containing liquid and solid food products on glycaemic response and sucrose hydrolysis by sucrase and glucose absorption in healthy humans.The secundary…
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Health condition
obesitas
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Intervention
Outcome measures
Primary outcome
The glycaemic response, measured as AUC of plasma glucose during 180 minutes.
Secondary outcome
1) The insulin response, measured as AUC of plasma insulin during 180 minutes.
2) The recovery of stable isotope in breath as a marker for sucrose
metabolisation during 180 minutes.
3) Ad libitum energy intake, measured as lunch after 240 minutes.
4) Appetite, measured using a VAS-questionnaire during 300 minutes.
5) Gastro-intestinal comfort using a questionnaire.
6) Study diary.
Background summary
One compound that is currently of interest is arabinose. Arabinose is a slowly
absorbed pentose with a sweet taste, which is naturally present in plants. It
can be derived from plant materials, such as sugar beets, by enzymatic
hydrolysis. Arabinose can act as a sucrose substitute in many foods, among
which fruit-based drinks and muffins.
Study objective
The primary objective is to quantify and compare the effect of added arabinose
to sucrose containing liquid and solid food products on glycaemic response and
sucrose hydrolysis by sucrase and glucose absorption in healthy humans.
The secundary objectives are:
1) To compare the effects of arabinose with xylose on glycaemic response and
sucrose hydrolysis by sucrase and glucose absorption in a sucrose containing
liquid food product.
2) To determine the effect of arabinose in liquid and solid sucrose containing
food products on ad libitum energy intake in a secondary meal.
3) To compare the effect of arabinose with xylose in liquid sucrose containing
food products on ad libitum energy intake in a secondary meal.
4) To determine the effect of arabinose in liquid and solid sucrose containing
food products on appetite feelings.
5) To compare the effect of arabinose with xylose in liquid sucrose containing
food products on appetite feelings.
6) To determine the acceptability of the treatments as measured by
gastro-intestinal comfort.
Study design
A randomized cross-over trial with 5 treatments, including a within subjects
design. There will be a washout period between treatments of one week. The
treatments are 1) Control drink; 2) Xylose drink; 3) Arabinose drink; 4)
Control muffin; and 5) Arabinose muffin. The drinks will be randomly offered in
the first three weeks and the solids will be offered randomly in the last two
weeks. Plasma glucose and insulin, 13C in exhaled breath, appetite and
gastro-intestinal comfort will be measured.
Intervention
All subjects will receive five interventions in an order randomized within
drinks and muffins. The food products will be consumed in fasting state as a
breakfast 1) Control drink, a fruit-based drink; 2) Xylose drink, a fruit-based
drink with added xylose (xylose added as 10 wt% of sugar); 3) Arabinose drink,
a fruit-based drink with added arabinose (arabinose added as 10 wt% of sugar);
4) Control muffin; 5) Arabinose muffin, a muffin with added arabinose
(arabinose added as 10 wt% of sugar).
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.
Xylose and arabinose are pentoses. Xylose, arabinose and 13C are present in a
wide range of plants, and form a part of the daily diet of most of the world*s
population. Xylose and arabinose used in this experiment are extracted from
sugar beets. The safety of xylose and 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. All treatments include a stable isotope tracer for sucrose absorption.
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. Before the experimental test days, subjects will
get an evening meal before the test day distributed by the study team. During
the test day subjects need to come in a fasting state to the University. Then,
8 blood samples (in total 56 ml) and 9 breath bags will be collected in 180
minutes. Also ad libitum energy intake will be measured at lunch at 240 minutes
after baseline. As well as a gastro-intestinal comfort questionnaire, an
appetite questionnaire and an evaluation questionnaire to ask which treatment
they thought they had. The total study lasts for five weeks. So, including the
information meeting and screening the subjects need to visit the University
seven times.
Van de Reijtstraat 15
Breda 4814 NE
NL
Van de Reijtstraat 15
Breda 4814 NE
NL
Listed location countries
Age
Inclusion criteria
• Male
• 18-35 Years old while signing the informed consent
• Good Dutch speaking, writing, understanding
• Healthy: as judged by the subject
• BMI: 18.5-25 kg/m2
• 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
• Normal Hb concentration >8.5 mmol/L
Exclusion criteria
• Allergy, intolerance or oversensitivity for the food products under study
• 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 muffins or to drink fruit-based drinks
• Being a vegetarian (not willing to eat meat)
• 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)
• Mental status that is incompatible with the proper conduct of the study
• Elite athletes, i.e. exercise > 7h/week vigorously
• 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 01 of the study)
• Willing to donate blood during the study
• Not having a general practitioner
• Being an employee of Wageningen University, department of Human Nutrition
• Current participation in other research
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51738.081.15 |
| OMON | NL-OMON23134 |