Clinical trial NCT03066323: Effect of Tea Extract on Post Prandial Blood Glucose
Official title: Effect of Tea Extract on Post Prandial Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Blood glucose
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
First posted: 2017-02-28
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incremental area under the plasma glucose versus time curve
timeFrame: 0-2 hours
Secondary outcomes:
measure: Incremental area under the plasma glucose versus time curve
timeFrame: 0-3 hours
measure: Maximum venous glucose concentration
timeFrame: 0-3 hours
measure: Total area under the post prandial insulin versus time curves
timeFrame: 0-2 hours
measure: Total area under the post prandial insulin versus time curves
timeFrame: 0-3 hours
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
Study officials:
affiliation: Consultant Gastroenterologist
name: Fergus Shanahan, Prof
role: PRINCIPAL_INVESTIGATOR
References: