Effect of Tea Extract on Post Prandial Blood Glucose
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 166
- Locations
- 2
- Primary Endpoint
- Incremental area under the plasma glucose versus time curve
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Tea extract
Rice with tea extract
Intervention: Rice with tea extract (Other)
No tea extract
Rice without tea extract
Intervention: Rice without tea extract (Other)
Outcomes
Primary Outcomes
Incremental area under the plasma glucose versus time curve
Time Frame: 0-2 hours
Secondary Outcomes
- Maximum venous glucose concentration(0-3 hours)
- Total area under the post prandial insulin versus time curves(0-3 hours)
- Incremental area under the plasma glucose versus time curve(0-3 hours)