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

NCT01561300 | Completed Results

• 1 other identifier: FDS-BEV-0284
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Black tea; Flow Mediated Dilation; Vascular function; India

Outcome Measures

Primary Outcomes (1)

• '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 Outcomes (2)

• Acute Effect of Tea vs Control

  From baseline on day 1 to 2 hours post consumption on day 1

• Chronic Effect of Tea vs Control

  From baseline at day 1 to baseline on day 8

Study Arms (2)

Control

PLACEBO COMPARATOR

Nutrition intervention study with a control

Other: Nutrition intervention study with a control

Tea extract

EXPERIMENTAL

Nutrition intervention study with a black tea extract

Other: Nutrition intervention study with a black tea extract

Interventions

Nutrition intervention study with a black tea extract OTHER

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.

Also known as: Black tea extract

Tea extract

Nutrition intervention study with a control OTHER

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.

Also known as: Control

Control

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unilever R&D: lead
• Lotus Labs Pvt. Ltd, Bangalore, India: collaborator
• Clumax Diagnostics, Bangalore, India: collaborator
• Quipu S.r.l, Pisa, Italy: collaborator

Study Sites (1)

Lotus Labs Pvt. Ltd.,

Bangalore, Karnataka, 560011, India

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr Theo Mulder
• Organization: Unilever R&D Vlaardingen

theo.mulder@unilever.com

+31 10 460 8315

Study Officials

• Anisha Pargal, Dr

  Unilever Industries Pvt. Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 23, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 5, 2017
• Results First Posted: April 5, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)