Healthy
Conditions
Keywords
Blood glucose
Brief summary
This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.
Detailed description
The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.
Interventions
Natural fruit extract consumed with rice
OTHERAssumed active
Assumed key active consumed with rice
OTHERPlacebo
Rice only
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) ≥ 18.5 and ≤ 25.0 kg/m2. * Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery \[with exception of cholecystectomy and appendectomy\] and inflammatory diseases). * Fasting blood glucose value of subjects is ≥ 3.4 and \<6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening.
Exclusion criteria
* Use of antibiotics within 3 months before day 1; use of any other medication within 14 days before day 1 except for both paracetamol and hormonal contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments | 0-2 hours | +iAUC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of 2-h and 3-h post-prandial insulin based on response to different treatments | 0-2 hours and 0-3 hours | tAUC |
| Max plasma concentration for assumed key active | 0-12 hours | Cmax |
| Time of max plasma concentration for assumed key active | 0-12 hours | Tmax |
| Change of 3-h PPG based on response to different treatments | 0-3 hours | +iAUC |
| Half-life of elimination phase for assumed key active | 0-12 hours | t1/2 |
| Total amount of assumed key active excreted in urine | 0-36 hours | — |
| AUC for plasma concentration versus time curve for assumed key active | 0-12 hours | AUC |
Countries
Germany
Outcome results
None listed