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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Nutrition intervention study with a control; Other: Nutrition intervention study with a black tea extract

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560011
      • Lotus Labs Pvt. Ltd.,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control; Nutrition intervention study with a control	Other: Nutrition intervention study with a control; 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. Products will be consumed for 8 days. On measurement days 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 of 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.; Other Names: Control
EXPERIMENTAL: Tea extract; Nutrition intervention study with a black 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. Products will be consumed for 8 days. On measurement days tea 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, 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.; Other Names: Black tea extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
'Acute-upon-chronic Effect' of Tea vs Control	Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps: 1 minute base scan to measure the baseline diameter of artery (baseline); 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease; 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion	Baseline day 1 to 2 hours post consumption on day 8.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Effect of Tea vs Control	Change in flow mediated dilation due to tea consumption when compared to control. FMD measurement included the following steps: 1 minute base scan to measure the baseline diameter of artery (baseline); 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease; 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion	From baseline on day 1 to 2 hours post consumption on day 1
Chronic Effect of Tea vs Control	Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps: 1 minute base scan to measure the baseline diameter of artery (baseline); 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease; 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion	From baseline at day 1 to baseline on day 8

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: March 20, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (ESTIMATE): March 23, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: India; Vascular function; Flow Mediated Dilation; Black tea
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: FDS-BEV-0284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO