Effect of Tea on Endothelial Function and Ischaemia-reperfusion Injury

NCT01660516 | Completed

• 2 other identifiers: TEA-IRITea-IR-Injury-FMD
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Tea consumption may impact upon the decrease in endothelial function after IR-injury. However, no previous study directly examined the potential of tea to impact upon the change in endothelial function after IR-injury. The investigators hypothesize that tea consumption counteracts endothelial damage in response to ischaemia reperfusion injury in healthy humans.

Conditions

Ischaemia Reperfusion Injury

Keywords

Camellia sinensis; flavonoids; cardiovascular risk; flow mediated dilation

Outcome Measures

Primary Outcomes (1)

• Change in Endothelial Function after ischaemia reperfusion injury

  Change in endothelial function (measured with flow mediated dilation) after ischaemia reperfusion injury (induced by 20 minutes ischemia and 20 min reperfusion) with and without precedence of tea consumption

  three weeks

Secondary Outcomes (1)

• Change in baseline flow mediated dilation after water/tea consumption

  three weeks

Study Arms (1)

Tea

Black tea ingestion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Twenty-one volunteers, aged between 30 and 70 years, were included in our study. All subjects were healthy and free of (a history of) cardiovascular disease or obesity (BMI \>30 kg/m2). Individuals were excluded if they reported a chronic or acute disease, including any kind of metabolic abnormality (such as diabetes mellitus) or cardiovascular disease. Habitual smokers (n=3) were instructed to withdraw from smoking on the day of testing. To further avoid confounding factors, the investigators also excluded individuals reporting daily intense sporting activities (\>10 h/w), and/or were treated with a diet due to any reason.

You may qualify if:

• Healthy volunteers : age 18-60
• All subjects: written informed consent

You may not qualify if:

• Smoking
• History of any cardiovascular disease
• Hypertension (in supine position: systole \>140 mmHg, diastole \>90 mmHg)
• Diabetes Mellitus
• Hyperlipidaemia (fasting total cholesterol \>6.5 mmol/L)
• Chronic use of medication known to interfere with the cardiovascular system
• Professional athletes
• Alcohol consumption \>14 units/week
• BMI \>30 kg/m2

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Unilever R&D: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6525 EX, Netherlands

Location

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dick Thijssen, Dr.

  Radboud University Medical Centre Nijmegen

  PRINCIPAL INVESTIGATOR

• Maria Hopman, Prof. Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 4, 2013

Record last verified: 2012-07

Locations

NL (1)