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Completed

NCT Number: NCT03066323

Effect of Tea Extract on Post Prandial Blood Glucose

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Food Clinical Trials

Cork, T12 H2TK, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rice with tea extract

Other

Rice with tea extract

Rice without tea extract

Other

Rice without tea extract

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

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Atlantia Food Clinical Trials

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2017
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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