Effect of Tea Extract on Post Prandial Blood Glucose
NCT03066323 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166
Last updated 2017-07-28
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
Interventions
- OTHER
-
Rice with tea extract
Rice with tea extract
- OTHER
-
Rice without tea extract
Rice without tea extract
Sponsors & Collaborators
-
Atlantia Food Clinical Trials
collaborator INDUSTRY -
Unilever R&D
lead INDUSTRY
Principal Investigators
-
Fergus Shanahan, Prof · Consultant Gastroenterologist
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-01-31
- Primary Completion
- 2017-06-30
- Completion
- 2017-06-30
Countries
- Ireland
Study Locations
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