Effect of Tea Extract on Post Prandial Blood Glucose

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT03066323
• Lead Sponsor: Unilever R&D

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-28
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Incremental area under the plasma glucose versus time curve	0-2 hours

Secondary Outcome Measures

Name	Time	Method
Maximum venous glucose concentration	0-3 hours
Incremental area under the plasma glucose versus time curve	0-3 hours
Total area under the post prandial insulin versus time curves	0-3 hours

Trial Locations

Locations (1)

Atlantia Food Clinical Trials; 🇮🇪 Cork, Ireland