To examine whether L-arabinose addition to a sucrose drink will lower glycaemic and insulinemic responses in people at increased risk of developing type II diabetes.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Glycaemic response
Secondary outcome
Insulin response, glucagon response, satiety response, glucose monitoring,
gastro-intestinal tolerance
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. Almost all research that
was done with arabinose consumption has been done in young healthy subjects and
were done in an acute setting.
Study objective
To examine whether L-arabinose addition to a sucrose drink will lower glycaemic
and insulinemic responses in people at increased risk of developing type II
diabetes.
Study design
The study is a randomized, cross-over study. All subjects receive 2 different
products in a randomized order. There will be a washout of 5 days. The test
products will be consumed in the morning when subjects are fasting. Thereafter
they will receive 2 days of controlled nutrition.
Intervention
Addition of 10% arabinose to a sucrose drink.
And we will explore the addition of 15% of arabinose to a normal diet.
Study burden and risks
After signing the informed consent the following measurements and
questionnaires will be taken: General questionnaire, health questionnaire, and
diabetes risk score questionnaire. At screening the following measurements will
be taken: height, body weight, waist and hip circumference, food frequency
questionnaire, fasting, 1h and 2h blood via finger prick after OGTT to
determine glucose response, and Hb concentration. On the evenings before the
experimental test days, subjects will consume every time a standardized evening
meal. During the test days subjects need to come in a fasting state to the
University and need to eat the controlled diet with or without L-arabinose
supplementation. Then, 8 blood samples (80 ml per test morning) and appetite
questionnaires will be collected in 180 minutes, as well as a gastro-intestinal
comfort questionnaire. Including the information meeting, and the screening,
the subjects need to visit the University 7 times.
During this 2-week period the following measurements will be taken: body weight
(1x), blood samples (16x), glucose monitoring (14 days), wellbeing diary (14
days).
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.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
* Age between 55-80 years
* BMI * 25.0 kg/m2
* Impaired fasting glucose (IFG; fasting glucose * 5.6 and < 7.0 mmol/L) or
* HbA1C: * 39 < 49 mmol/mol
Exclusion criteria
* Diagnosed diabetes,
* Diagnosed liver, pancreas or endocrine diseases which could affect the study results,
* Having gastro-intestinal problems,
* Use of medication or supplements which could affect the study results (Moreover, chronic medication and supplements should be used as normal when they donot affect the study results),
* Allergy, intolerance or oversensitivity for food products,
* Sensitive to medical skin adhesives,
* Following a medically prescribed, low energy or low carbohydrate diet,
* Unwilling to consume the provided diets,
* >5 kg weight change during the last 3 months,
* Current antibiotics usage or in the two months prior to the screening session,
* Excessive alcohol consumption (>21 glasses/week on average for men and >14 glasses/week for women),
* Having blood vessels that are too difficult for inserting a cannula, as judged by the study nurse,
* Not normal haemoglobin (Hb) concentration: <8.5 mmol/L for men and <7.5 mmol/L for women,
* Recent blood donation (<1 month prior to the first study day),
* Planning to donate blood as a blood donor during the study,
* Mental status that is incompatible with the conduct of the study,
* Being an employee of Wageningen University, division of Human Nutrition and Health,
* Current participation in other research (except EetMeetWeet).
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 | NL66558.081.18 |
| OMON | NL-OMON27001 |