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: August 12, 2013
Last verified: May 2012
  Purpose

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.


Condition Intervention
Healthy
Other: Nutrition intervention study with a black tea extract

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • '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.



Secondary Outcome Measures:
  • 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



Enrollment: 30
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control 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.

Experimental: Tea extract 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.


Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561300

Locations
India
Lotus Labs Pvt. Ltd.,
Bangalore, Karnataka, India, 560011
Sponsors and Collaborators
Unilever R&D
Lotus Labs Pvt. Ltd, Bangalore, India
Clumax Diagnostics, Bangalore, India
Quipu S.r.l, Pisa, Italy
Investigators
Study Director: Anisha Pargal, Dr Unilever Industries Pvt. Ltd
  More Information

No publications provided

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01561300     History of Changes
Other Study ID Numbers: FDS-BEV-0284
Study First Received: March 20, 2012
Last Updated: August 12, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by Unilever R&D:
Black tea
Flow Mediated Dilation
Vascular function
India

ClinicalTrials.gov processed this record on October 20, 2014