Effect of Tea Extract on Post Prandial Blood Glucose

Healthy Clinical Trial

Official title:

Effect of Tea Extract on Post Prandial Blood Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066323
• Other study ID #: REF-BEV-2731
• Status: Completed
• Phase: N/A
• First received: February 23, 2017
• Last updated: July 27, 2017
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Rice with tea extract
Rice with tea extract
• Rice without tea extract
Rice without tea extract

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials	Cork

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Atlantia Food Clinical Trials

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental area under the plasma glucose versus time curve		0-2 hours
Secondary	Incremental area under the plasma glucose versus time curve		0-3 hours
Secondary	Maximum venous glucose concentration		0-3 hours
Secondary	Total area under the post prandial insulin versus time curves		0-2 hours
Secondary	Total area under the post prandial insulin versus time curves		0-3 hours