Effect of Tea Extract on Post Prandial Blood Glucose

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Rice with tea extract; Other: Rice without tea extract

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland, T12 H2TK
    • Atlantia Food Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tea extract; Rice with tea extract	Other: Rice with tea extract; Rice with tea extract
Placebo Comparator: No tea extract; Rice without tea extract	Other: Rice without tea extract; Rice without tea extract

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Atlantia Food Clinical Trials
• Investigators: Principal Investigator: Fergus Shanahan, Prof, Consultant gastroenterologist

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Blood glucose
• Other Study ID Numbers: REF-BEV-2731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO