No registrations found.
ID
Source
Brief title
Health condition
Not applicable
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the glycemic index of the test products
Secondary outcome
The secondary outcome parameters in this study are:
- GL=GI*available carbohydrate/given amount
Capillary blood glucose mmol/l and iAUC0-120 [mmol/l*min] of the reference product and test product(s)
- Capillary blood glucose iCmax [mmol/l] and Tmax [min] of the reference product and test product(s)
- Appetite profile and liking of the test product using visual analogue scales (VAS, mm)
Background summary
This is a generic protocol for the assessment of glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or (one of) the test product(s). Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Appetite and liking will be assessed by completing a VAS scale on several time-points. Several nutritional products will be tested over time.
Study objective
Not applicable
Study design
Time points of the outcome; for example: V0 (screening); V1; V2 (≥48 hrs), V# (≥48 hrs)
Intervention
Duration of intervention: depending on number of test products
Intervention group:
- Test product(s):
All test products contain 25 or 50 g of available carbohydrates.
- Reference product (one to be chosen):
a) anhydrous glucose powder (25 or 50 g)
b) dextrose (glucose monohydrate, 27,5 or 55 g)
c) commercial solution containing glucose (25 or 50 g)
Danone Nutricia Research
+31 30 2095 000
register.clinicalresearchnutricia@danone.com
Danone Nutricia Research
+31 30 2095 000
register.clinicalresearchnutricia@danone.com
Inclusion criteria
1. Age ≥ 18 and ≤ 60 years
2. Body Mass Index (BMI) ≥ 18.5 and ≤ 24.9 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 interferes with glucose
2. Any use of anticoagulants, 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 influence digestion and absorption of nutrients within 1 week of screening
4. Any known relevant food allergy or intolerance
5. Adherence to a strict vegan diet and/or a weight loss program
6. Any known bleeding disorder
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8151 |
| CCMO | NL71190.056.19 |
| OMON | NL-OMON49247 |