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Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males

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Unilever

Status

Completed

Conditions

Healthy

Treatments

Other: Nutrition intervention study with a black tea extract
Other: Nutrition intervention study with a control

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT01561300
FDS-BEV-0284

Details and patient eligibility

About

This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.

Full description

Flow mediated dilation (FMD) is a non-invasive measurement technique performed using ultrasound equipment to measure hyperaemia induced dilation of blood vessels. Evidence from prospective studies suggests that FMD is independently inversely associated with cardiovascular events.

Enrollment

30 patients

Sex

Male

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male volunteers aged between >_30 _< 50 years of age
  • Body Mass Index (BMI) of >_18 and _< 25.0 kg/m2
  • Systolic blood pressure >_140 and >_100 mmHg and diastolic blood pressure < 90 and > 70 mmHg
  • Subjects who consume _< 2 cups of coffee per day
  • Subjects who drink tea regularly (>_ 2 cups per day)
  • Apparently healthy, with no reported medical condition which might affect the assessment as judged by the study physician or/and PI
  • No prescribed medical treatment that may affect study parameters as judged by the Study Physician
  • Subject willing to abstain from alcohol on day before and on the day of assessment
  • Willing to sign the informed consent form

Exclusion criteria

  • Smokers and/or tobacco chewers
  • Those who consume regular alcohol (> 160 ml of alcohol per week)
  • Reported intense sport activities > 10h/week
  • Participating in any other clinical study concurrently or if participated in any study during 2 months preceding the screening visit

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Nutrition intervention study with a control
Treatment:
Other: Nutrition intervention study with a control
Tea extract
Experimental group
Description:
Nutrition intervention study with a black tea extract
Treatment:
Other: Nutrition intervention study with a black tea extract

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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