CClinicalTrials.gg
CompletedNCT03066323Updated Jul 28, 2017

Effect of Tea Extract on Post Prandial Blood Glucose

An interventional study of Rice with tea extract and Rice without tea extract in Healthy, sponsored by Unilever R&D. Completed at 1 site in Ireland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-28.

Sponsored by Unilever R&D · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Blood glucose
03

In context

Lead sponsor

Unilever R&D is the lead sponsor of 69 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
166 participants (actual)

Study arms

  • Active comparator
    Tea extract

    Rice with tea extract

    Other: Rice with tea extract

  • Placebo comparator
    No tea extract

    Rice without tea extract

    Other: Rice without tea extract

Interventions

  • OtherRice with tea extract

    Rice with tea extract

  • OtherRice without tea extract

    Rice without tea extract

06

What researchers measure

Primary outcomes

  1. Incremental area under the plasma glucose versus time curve

    Time frame: 0-2 hours

Secondary outcomes

  1. Incremental area under the plasma glucose versus time curve

    Time frame: 0-3 hours

  2. Maximum venous glucose concentration

    Time frame: 0-3 hours

  3. Total area under the post prandial insulin versus time curves

    Time frame: 0-2 hours

  4. Total area under the post prandial insulin versus time curves

    Time frame: 0-3 hours

07

Study locations

1 site
  • Atlantia Food Clinical Trials
    Cork, T12 H2TK, Ireland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03066323
Lead sponsor
Unilever R&D
Collaborators
Atlantia Food Clinical Trials
Responsible party
Sponsor
First posted
Feb 28, 2017
Start date
Jan 2017
Primary completion
Jun 2017
Completion
Jun 2017
Last update
Jul 28, 2017

Study contacts

Fergus Shanahan, Prof
principal investigator · Consultant Gastroenterologist

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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