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Trial Outcomes & Findings for Flow Mediated Dilation in Response to Black Tea (NCT NCT02273323)

NCT ID: NCT02273323

Last Updated: 2017-02-15

Results Overview

Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software: * 1 minute baseline scan to measure the baseline diameter of artery * 5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Before and 2 hours after test product intake

Results posted on

2017-02-15

Participant Flow

53 subjects were screened between August 2014 and and October 2015

All 30 subjects meeting the inclusion criteria were randomised

Participant milestones

Participant milestones
Measure
Tea Then Placebo
Subjects first received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar. After a washout of at least 1 week, they received a single acute dose of placebo consisting of tea flavour, colouring and sugar.
Placebo Then Tea
Subjects first received a single acute dose of placebo consisting of tea flavour, colouring and sugar. After a washout of at least 1 week, they received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar
Overall Study
STARTED
15
15
Overall Study
COMPLETED
15
15
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flow Mediated Dilation in Response to Black Tea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=30 Participants
Participants who were randomised to either receive Tea first followed by Placebo or Placebo first followed by Tea
Age, Continuous
53 years
n=113 Participants
Gender
Female
7 Participants
n=113 Participants
Gender
Male
23 Participants
n=113 Participants
Body Mass Index
26.3 kg/m^2
n=113 Participants
Systolic blood pressure
145 mmHg
n=113 Participants
Diastolic blood pressure
92 mmHg
n=113 Participants

PRIMARY outcome

Timeframe: Before and 2 hours after test product intake

Population: All participants who received at least one dose of each intervention and completed all study visits

Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software: * 1 minute baseline scan to measure the baseline diameter of artery * 5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter

Outcome measures

Outcome measures
Measure
Tea Beverage
n=30 Participants
Participants when they received a single dose of black tea infusion with added sugar
Placebo Beverage
n=30 Participants
Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
Flow Mediated Dilation
FMD before test product intake
5.24 percentage of change in diameter
Standard Deviation 2.42
5.02 percentage of change in diameter
Standard Deviation 2.14
Flow Mediated Dilation
FMD two hours after test product intake
6.05 percentage of change in diameter
Standard Deviation 2.33
5.74 percentage of change in diameter
Standard Deviation 2.66

SECONDARY outcome

Timeframe: 2.5 hours after test product intake

Population: All participants who received at least one dose of each intervention and completed all study visits

Endothelium-independent dilation after glyceryl trinitrate defined as maximal percent increase in diameter

Outcome measures

Outcome measures
Measure
Tea Beverage
n=30 Participants
Participants when they received a single dose of black tea infusion with added sugar
Placebo Beverage
n=30 Participants
Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
Endothelium-independent Vasodilation
12.1 percentage of change in diameter
Interval 10.6 to 13.6
11.4 percentage of change in diameter
Interval 9.9 to 12.9

SECONDARY outcome

Timeframe: Before and 110 minutes after test product intake

Population: All participants who received at least one dose of each intervention and completed all study visits

Systolic blood pressure measured while lying down

Outcome measures

Outcome measures
Measure
Tea Beverage
n=30 Participants
Participants when they received a single dose of black tea infusion with added sugar
Placebo Beverage
n=30 Participants
Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
Systolic Blood Pressure Supine
Before test product intake
135.5 mmHg
Standard Deviation 14.2
138.1 mmHg
Standard Deviation 14.0
Systolic Blood Pressure Supine
After test product intake
145.0 mmHg
Standard Deviation 16.2
147.2 mmHg
Standard Deviation 15.7

SECONDARY outcome

Timeframe: Before and 110 minutes after test product intake

Population: All participants who received at least one dose of each intervention and completed all study visits

Diastolic blood pressure measured while lying down

Outcome measures

Outcome measures
Measure
Tea Beverage
n=30 Participants
Participants when they received a single dose of black tea infusion with added sugar
Placebo Beverage
n=30 Participants
Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
Diastolic Blood Pressure Supine
Before test product intake
85.1 mmHg
Standard Deviation 10.2
85.7 mmHg
Standard Deviation 10.2
Diastolic Blood Pressure Supine
After test product intake
88.9 mmHg
Standard Deviation 10.9
89.5 mmHg
Standard Deviation 10.5

SECONDARY outcome

Timeframe: Before and 90 minutes after test product intake

Population: All participants who received at least one dose of each intervention and completed all study visits

Systolic blood pressure measured while sitting

Outcome measures

Outcome measures
Measure
Tea Beverage
n=30 Participants
Participants when they received a single dose of black tea infusion with added sugar
Placebo Beverage
n=30 Participants
Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
Systolic Blood Pressure Sitting
After test product intake
146.4 mmHg
Standard Deviation 13.1
148.5 mmHg
Standard Deviation 15.0
Systolic Blood Pressure Sitting
Before test product intake
134.7 mmHg
Standard Deviation 13.7
137.2 mmHg
Standard Deviation 13.8

SECONDARY outcome

Timeframe: Before and 90 minutes after test product intake

Population: All participants who received at least one dose of each intervention and completed all study visits

Diastolic blood pressure measured while sitting

Outcome measures

Outcome measures
Measure
Tea Beverage
n=30 Participants
Participants when they received a single dose of black tea infusion with added sugar
Placebo Beverage
n=30 Participants
Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
Diastolic Blood Pressure Sitting
Before test product intake
86.1 mmHg
Standard Deviation 10.3
87.7 mmHg
Standard Deviation 10.5
Diastolic Blood Pressure Sitting
After test product intake
90.7 mmHg
Standard Deviation 10.5
89.4 mmHg
Standard Deviation 10.0

Adverse Events

Tea Beverage

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Placebo Beverage

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Tea Beverage
n=30 participants at risk
Participants when they received a single dose of black tea infusion with added sugar
Placebo Beverage
n=30 participants at risk
Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/30
3.3%
1/30 • Number of events 1
Gastrointestinal disorders
Nausea
3.3%
1/30 • Number of events 1
0.00%
0/30

Additional Information

Theo Mulder

Unilever R&D Vlaardingen

Phone: +31 10 460 8315

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60