Effect of Tea Extract on Post Prandial Blood Glucose

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03066323
• Date of registration: 23/02/2017
• Prospective Registration: No
• Primary sponsor: Unilever R&D
• Public title: Effect of Tea Extract on Post Prandial Blood Glucose
• Scientific title: Effect of Tea Extract on Post Prandial Blood Glucose
• Date of first enrolment: January 2017
• Target sample size: 166
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03066323
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Ireland

Contacts

• Name: Fergus Shanahan, Prof
• Affiliation: Consultant Gastroenterologist

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Other: Rice with tea extract

Other: Rice without tea extract

Primary Outcome(s)

Incremental area under the plasma glucose versus time curve [Time Frame: 0-2 hours]

Secondary Outcome(s)

Maximum venous glucose concentration [Time Frame: 0-3 hours]

Total area under the post prandial insulin versus time curves [Time Frame: 0-3 hours]

Total area under the post prandial insulin versus time curves [Time Frame: 0-2 hours]

Incremental area under the plasma glucose versus time curve [Time Frame: 0-3 hours]

Secondary ID(s)

REF-BEV-2731

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Atlantia Food Clinical Trials