The objective of the study is to assess whether the postprandial glucose response of the adapted product is equivalent to the postprandial glucose response of the original product.
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Health condition
studie met gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blood glucose iAUC0-120 [mmol/L*min] and the blood glucose iCmax [mmol/L] (test
product versus control product)
Secondary outcome
- GI = blood glucose iAUC0-120 [mmol/L] of test product / mean blood glucose
iAUC0-120 [mmol/L] of reference product
- Glycemic Load (GL) = GI * available carbohydrate/given amount of carbohydrate
Background summary
Nutricia has a nutritionally complete tube feed specific for diabetes patients
on the market. It has been shown that after intake of this product postprandial
glucose responses were decreased as compared to standard tube feeds, thereby
contributing to achieving glycaemic control, which is one of the major goals in
the management of diabetes. The original diabetes specific tube feed requires a
change in recipe. This change will be the use of another carbohydrate source
and as a consequence there is also a change in the level of carbohydrates. In
addition a few minor changes in micronutrient levels will be implemented. These
changes in carbohydrate source and amount might impact the postprandial glucose
response.
Study objective
The objective of the study is to assess whether the postprandial glucose
response of the adapted product is equivalent to the postprandial glucose
response of the original product.
Study design
This is a randomised, single blind, crossover, single-centre study.
Intervention
Test product: diabetes specific tube feed new recipe (approximately 250 ml)
Control product: diabetes specific tube feed original recipe (approximately 250
ml)
Reference product: glucose solution (25 grams of glucose dissolved in 250 ml of
water); to determine the glycemic index of the test product
Study burden and risks
Subjects should visit the study site six times: one screening visit, three
study visits to measure the glucose response to the reference product and two
study visits to measure the glucose response to the test and control product.
During each study visit, blood is sampled using a finger prick just before and
after the intake at 8 timepoints spread over 2,5 hours for analysis of glucose.
A few days after the last study visit a follow-up phone call will be done.
During participation subjects should adhere to a number of rules related to
medication use and lifestyle. The study will be performed with healthy adult
volunteers and the subjects will take a nutritional product or a standard
glucose solution once every visit. This is expected to cause minimal discomfort
for the subject. The risks of the other study procedure are very limited as
well; there is a small risk of experiencing pain/discomfort from finger prick
method.
The burden for participants in this study is considered small and the benefits
of obtaining more knowledge on the characteristics of nutritional products
outweighs the minimal burden.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 18 and <= 65 years
2. Body Mass Index (BMI) >= 18.5 and <= 27.0 kg/m2
3. Written informed consent
4. Willingness and ability to comply with the protocol
5. Judged by the Investigator to be in good health
Exclusion criteria
1. Known Diabetes Mellitus type I or type II, rebound hypoglycaemia and/or any
other medical condition that
2. Any use of anticoagulants, systemic steroids, protease inhibitors or
antipsychotics and/or any medication known to affect glucose tolerance and/or
to influence digestion and absorption of nutrients within 1 week of screening,
in opinion of the Investigator
3. Any known disease which influences digestion and absorption of nutrients
within 1 week of screening (in the opinion of the Investigator)
4. Allergy to soy and/or any other known relevant food allergy or intolerance
in opinion of the Investigator
5. Adherence to a strict vegan diet
6. Adherence to a weight loss program
7. Picky/fussy eater (being very selective about what to eat) or eating disorder
8. Known pregnancy and/or lactation
9. Current smoking or stopped smoking for < 1 month prior to screening (except
for incidental smoking of <= 3 cigarettes/cigars/pipes per week on average in
the last month)
10. Average alcohol use of > 21 glasses per week for men or > 14 glasses per
week for women (on average during the last 6 months)
11. Drug or medicine abuse in opinion of the Investigator
12. Any known bleeding disorder
13. Active participation in any other clinical study with investigational or
marketed products concomitantly or within 4 weeks before study visit 1, in the
opinion of the Investigator
14. Major medical or surgical event requiring hospitalization within the
preceding 3 months and/or scheduled in the period of study participation
relevant in the opinion of the Investigator
15. Investigator*s uncertainty about the willingness or ability of the subject
to comply with the protocol requirements
16. Employees of Nutricia Research and/or family members or relatives of
employees
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 | NL81436.056.22 |