Healthy
Conditions
Keywords
Blood glucose
Brief summary
This study is designed as a randomized, single blind (data evaluation), placebo controlled, full cross-over study and conducted in 166 (including 10% drop out) males and females, aged ≥ 18 and ≤ 65 and waist circumference of \>80 cm for women and \>94 cm for men (indicating increased risk of metabolic complications (WHO)) and having a sedentary lifestyle. Subjects will receive rice with a tea extract and rice without a tea extract. There will be three visits to the test facility: one screening visit and two intervention visits. During the intervention visits venous blood samples will be collected for the analysis of plasma glucose (t = -30m, -5m, 15m, 30m, 45m, 1h, 1h 30m, 2h and 3h, relative to the start of rice consumption ) and serum insulin (t = -5m, 30m, 1h, 2h and 3h). Between the two intervention visits subjects have an interval of one week. This interval is required to minimize subject discomfort from repeated blood sampling.
Interventions
OTHERRice with tea extract
Rice with tea extract
OTHERRice without tea extract
Rice without tea extract
Sponsors
Atlantia Food Clinical Trials
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Waist circumference \> 80 cm for women and \> 94 cm for men; * Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery 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; * Being physically inactive (meaning less than five times 30 minutes of moderate activity per week, or less than three times 20 minutes of vigorous activity per week, or equivalent);
Exclusion criteria
* Use of antibiotics within 3 months before first intake of test product; * Use of any other medication except paracetamol, within 14 days before first intake of test product; * Consumption of \> 14 units (female subjects) and \> 21 units (male subjects) alcoholic drinks in a typical week; * Dislike, known allergy or intolerance to the treatments or other food products provided during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental area under the plasma glucose versus time curve | 0-2 hours |
Secondary
| Measure | Time frame |
|---|---|
| Incremental area under the plasma glucose versus time curve | 0-3 hours |
| Maximum venous glucose concentration | 0-3 hours |
| Total area under the post prandial insulin versus time curves | 0-2 hours |
Countries
Ireland
Outcome results
None listed