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

This study has been completed.
Sponsor:
Collaborators:
Lotus Labs Pvt. Ltd, Bangalore, India
Clumax Diagnostics, Bangalore, India
Quipu S.r.l, Pisa, Italy
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01561300
First received: March 20, 2012
Last updated: May 25, 2012
Last verified: May 2012
History of Changes

March 20, 2012
May 25, 2012
March 2012
April 2012   (final data collection date for primary outcome measure)
'Acute on chronic effect' of Tea Extract on flow mediated dilation as compared to placebo [ Time Frame: Day 1 and day 8 of both interventions ] [ Designated as safety issue: No ]

The study products include placebo, control and test treatment (tea). Placebo is consumed during for the run-in and washout (both 6 days). On the morning of day 1 FMD is measured (M1). Two hours after consumption of tea extract or control another FMD measurement is taken (M2). On days 2 to 7 subjects will continue to consume the study product (control or tea). On day 8, the procedure conducted on day 1 will be repeated (M3 and M4).

Acute-on-chronic = M4-M1.
Same as current
Complete list of historical versions of study NCT01561300 on ClinicalTrials.gov Archive Site
  • Acute effect of Tea Extract on flow mediated dilation as compared to placebo [ Time Frame: Day 1 of both interventions ] [ Designated as safety issue: No ]

    On day 1 FMD is measured (M1). Two hours after consumption of tea extract or control another FMD measurement is taken (M2).

    Acute = M2-M1

  • chronic effect of Tea Extract on flow mediated dilation as compared to placebo [ Time Frame: Day 1 and day 8 of both interventions ] [ Designated as safety issue: No ]

    The study products include placebo, control and test treatment (tea). Placebo is consumed during for the run-in and washout (both 6 days). On the morning of day 1 FMD is measured (M1). Two hours after consumption of tea extract or control another FMD measurement is taken (M2). On days 2 to 7 subjects will continue to consume the study product (control or tea). On day 8, the procedure conducted on day 1 will be repeated (M3 and M4).

    Chronic = M3-M1
Same as current
Not Provided
Not Provided
 
Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males
Efficacy of Standardized Brooke Bond Black Tea Extract on Flow-Mediated Dilation After an Acute Dose as Well as After One Week of Consumption in Healthy Adult Indian Males

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Healthy
Other: Nutrition intervention study with a black tea extract

Tea extract: 1800 mg/day standardized Brooke Bond black tea extract equivalent to 400 mg flavonoids dissolved in 240 ml hot water.

Control: 1800 mg/day of a powder that gives a flavoured beverage with a color similar to black tea dissolved in 240 ml hot water.

Both products will be consumed for 8 days. On measurement days active or control will be given to the subjects as a single acute dose and 2 grams of sugar will be added.

On day 2-7 subjects will consume 3 cups or tea extract or control, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added.
  • Placebo Comparator: Control
    Intervention: Other: Nutrition intervention study with a black tea extract
  • Experimental: Tea extract
    Intervention: Other: Nutrition intervention study with a black tea extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2012
April 2012   (final data collection date for primary outcome measure)

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
Male
30 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01561300
FDS-BEV-0284
No
Unilever R&D
Unilever R&D
  • Lotus Labs Pvt. Ltd, Bangalore, India
  • Clumax Diagnostics, Bangalore, India
  • Quipu S.r.l, Pisa, Italy
Study Director: Anisha Pargal, Dr Unilever Industries Pvt. Ltd
Unilever R&D
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP