Effect of Tea Extract on Post Prandial Blood Glucose

NCT03066323 | Completed

• 1 other identifier: REF-BEV-2731
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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

Keywords

Blood glucose

Outcome Measures

Primary Outcomes (1)

• Incremental area under the plasma glucose versus time curve

  0-2 hours

Secondary Outcomes (4)

• 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

Study Arms (2)

Tea extract

ACTIVE COMPARATOR

Rice with tea extract

Other: Rice with tea extract

No tea extract

PLACEBO COMPARATOR

Rice without tea extract

Other: Rice without tea extract

Interventions

Rice with tea extract OTHER

Rice with tea extract

Tea extract

Rice without tea extract OTHER

Rice without tea extract

No tea extract

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, T12 H2TK, Ireland

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Fergus Shanahan, Prof

  Consultant Gastroenterologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)