Effect of Tea Extract on Post Prandial Blood Glucose

NCT ID: NCT03066323

Last Updated: 2017-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Tea extract

Rice with tea extract

Group Type: ACTIVE_COMPARATOR

Rice with tea extract

Intervention Type: OTHER

Rice with tea extract

No tea extract

Rice without tea extract

Group Type: PLACEBO_COMPARATOR

Rice without tea extract

Intervention Type: OTHER

Rice without tea extract

Interventions

Rice with tea extract

Rice with tea extract

Intervention Type: OTHER

Rice without tea extract

Rice without tea extract

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

Unilever R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fergus Shanahan, Prof

Role: PRINCIPAL_INVESTIGATOR

Consultant Gastroenterologist

Locations

Atlantia Food Clinical Trials

Cork, , Ireland

Countries

Ireland

Other Identifiers

REF-BEV-2731

Identifier Type: -

Identifier Source: org_study_id