Effect of Tea Extract on Post Prandial Blood Glucose

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Tea Extract on Post Prandial Blood Glucose

Conditions
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Healthy

Intervention / Treatment
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* Other: Rice with tea extract
* Other: Rice without tea extract


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tea extract<br>Rice with tea extract | Other: Rice with tea extract<br>* Rice with tea extract<br>|
| Placebo Comparator: No tea extract<br>Rice without tea extract | Other: Rice without tea extract<br>* Rice without tea extract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental area under the plasma glucose versus time curve |  | 0-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Total area under the post prandial insulin versus time curves |  | 0-3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood glucose