To investigate the effect of specially bred snack cucumbers (Trees) intended for human consumption on glucose homeostasis in comparison to common snack cucumbers (Cucumis Sativus) after OGTT in obese individuals.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameters will be glucose, insulin and glucagon (measured regularly
over 3.5 hrs during the OGTT).
Secondary outcome
not applicable
Background summary
In this study the possible effect of a specially bred cucumber for human
consumption on the bloodglucose level will be investigated in people withe
obesity.
In healthy people the body regulates the glucose homeastasis with insuline. In
type 2 diabetes, the body is not able to keep the glucose levels in good
balance, because the body does not responde well enough /or there is too
little insuline in the body. Without good working insuline the body is not
capable to get rid to the glucose in the blood. The blood glucose levels stay
too high. Besides, the fat metabolism is not functioning well. For people with
diabetes having a special diet can be of value for the glucose balance in the
blood. In animal research it appears that eating cucumbers can positively
effect the glucose levels in blood. Sportfruit B.V. in Poeldijk has bred
special cucumbers that might lower the blood glucose levels in the blood better
than normal cucumber do.. In case Trees cucumbers should have a positive effect
on glucose homeostasis, the consumption of these cucumbers might have an added
value in combination with a T2DM diet.
Study objective
To investigate the effect of specially bred snack cucumbers (Trees) intended
for human consumption on glucose homeostasis in comparison to common snack
cucumbers (Cucumis Sativus) after OGTT in obese individuals.
Study design
double blind, placebo-controlled, cross-over randomized trial to determine the
possible effect of specially bred cucumbers (Trees) on glucose homeostasis.
Intervention
Eating 5 specially bred (active) and normal snack (placebo) cucumbers.
Drinking of 300 ml glucose water for the oral glucose tolerance test
Study burden and risks
The potential risk for the subjects associated with consumption of the
specially bred snack cucumber (Trees) is minimal. Although it is expected by
the sponsor that consumption of the specially bred snack cucumber will cause a
decrease of the glucose level and that this effect is more prominent compared
to the effect caused by a common snack cucumber (placebo), this difference is
not expected to result in a potential risk for the subject. The consumption of
the specially bred cucumbers (Trees) is considered safe.
ABC Westland 100,
2685 DB Poeldijk
NL
ABC Westland 100,
2685 DB Poeldijk
NL
Listed location countries
Age
Inclusion criteria
Male or female subjects, age 18 to 65 , inclusive. Body Mass Index (BMI) 28 and above
Exclusion criteria
Any clinically significant abnormality as determined by medical history taking and physical examinations obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
Clinically relevant abnormal laboratory results, ECG, vital signs at screening that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34589.058.10 |