The objective of the study is to determine and compare the effects of L-arabinose added to 1) water with sucrose, 2) water with sucrose and fat, and 3) water with sucrose and starch on glycaemic and insulinemic responses in healthy adults. The…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are glycaemic and insulinemic response.
Secondary outcome
Secondary outcomes are:
1) appetite ratings,
2) subsequent ad libitum energy intake,
3) tolerance of the treatments,
4) gastro-entero endocrine markers,
5) L-arabinose in the blood, and
6) excretion of L-arabinose in urine.
Background summary
L-arabinose is a pentose which is naturally present in plants, e.g. in the
sugar beet. L-arabinose is a sucrase inhibitor and lowers glucose and insulin
responses when it is consumed together with sucrose. However, when L-arabinose
is consumed in a muffin, in cereal clusters or in a mixed meal, no significant
lowering of the glycaemic response was observed. Fat, starch and protein are
nutrients present in solid products and less in drinks. We hypothesize that the
macronutrient content of the meal disturbs the positive effect of L-arabinose.
We expect that fat will reduce the glycaemic response by delaying gastric
emptying, which causes a slower entrance in the duodenum of sucrose and
L-arabinose. For starch we expect that the glycaemic response will be so much
increased that the inhibiting effect on sucrase may be diminished, by an
increased presence of glucose in the duodenum. For now, we want to know how
much the separate effects of fat and starch will be.
Study objective
The objective of the study is to determine and compare the effects of
L-arabinose added to 1) water with sucrose, 2) water with sucrose and fat, and
3) water with sucrose and starch on glycaemic and insulinemic responses in
healthy adults.
The secondary aims are to determine and compare the effects of L-arabinose
added to 1) water with sucrose, 2) water with sucrose and fat, and 3) water
with sucrose and starch on:
1) appetite ratings,
2) subsequent ad libitum energy intake,
3) tolerance of the treatments,
4) gastro-entero endocrine markers,
5) L-arabinose in the blood, and
6) excretion of L-arabinose in urine.
Study design
The study is a randomized cross-over trial with six treatments divided in three
blocks and blind within the blocks. All participants will receive 6 treatments
in a randomized order. There will be a washout period between treatments of a
minimum of three days. The test products will be consumed after an overnight
fast.
Intervention
All products contain 50g sucrose and 250g water. The testproducts are:
1) Control sucrose solution (50g sucrose)
2) L-arabinose sucrose solution (Control + 5g L-arabinose)
3) Sucrose and fat solution (Control + 22g fat)
4) Fat L-arabinose and sucrose solution (Control + 5g L-arabinose + 22g fat)
5) Sucrose and starch solution (Control + 50g starch)
6) Starch L-arabinose and sucrose solution (Control + 5g L-arabinose + 50g
starch)
Study burden and risks
The intervention is non-therapeutic to the subjects. The risk associated with
participation is negligible and the burden can be considered as moderate.
L-arabinose is a pentose which is present in a wide range of plants, such as
sugar beet. The safety of L-arabinose is evaluated by legal authorities and it
has been classified as self-affirmed GRAS in the USA.
After signing the informed consent the following measurements and
questionnaires are 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 every time the same evening meal. During the test
morning subjects need to come in a fasting state to the University. Then, 8
blood samples (80 ml per test morning) 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 during and after the test day. The total study lasts for six
weeks. So, including the information meeting, screening and returning their
urine containers the subjects need to visit the University 14 times.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
- 18-35 years old while signing the informed consent
- good Dutch writing, speaking, understanding
- healthy: as judged by the participant
- stable body weight, i.e. no reported weight loss or weight gain of >5kg in the two months prior to the screening session
- normal Fasting glucose concentration <6.1mmol/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 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 the first testday of the study)
- planning to donate blood as a blood donor during the study
- not having a general practitioner
- being an employee or student performing their thesis or internship of Wageningen University, division 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 | NL61428.081.17 |
OMON | NL-OMON22940 |