Acute effects of coffee on endothelial function and glucose metabolism in healthy volunteers

Not Applicable

Completed

• Conditions: Cardiovascular and metabolic diseases; Nutritional, Metabolic, Endocrine; Metabolic diseases

• Registration Number: ISRCTN85096812
• Lead Sponsor: niversity of Palermo (Italy)

Brief Summary

2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20125186 (added 04/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-06
• Study Completion: 2007-12-15
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male and female healthy subjects
2. Range of age: 25 - 50 years
3. Range of Body Mass Index (BMI): 20 - 28 kg/m^2

Exclusion Criteria

1. Any metabolic, cardiovascular or systemic disease
2. Any drug treatment
3. Smoking habits
4. Pregnancy or lactation in the last six months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Amendment as of 15/05/2008: Please note that the primary outcome measure was assessed in only 20 participants.<br><br> Acute effects of both coffees (caffeinated and decaffeinated) on endothelial function, measured as Flow Mediated Dilation, and on glucose metabolism, as blood concentrations of glucose, insulin and c-peptide, will be measured in each occasion before, 30 and 60 minutes after coffee ingestion.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Amendment as of 15/05/2008: Please note that all secondary outcome measures were assessed in only 20 participants, except the QTc interval measurement (no. 3 below), which was carried out for all participants.<br><br> 1. Intra-renal haemodynamic measurements (resistance and pulsatility indexes), obtained before and 60 minutes after coffee ingestion in both occasions<br> 2. Blood pressure, obtained before and 60 minutes after coffee ingestion in both occasions<br> 3. Electrocardiogram with QTc interval measurement, obtained before and 60 minutes after coffee ingestion in both occasions<br> 4. A blood sample will be collected before and 60 minutes after coffee ingestion in both occasions and the serum samples will be frozen at -80°C for measurement of some cytokines (Interleukin-6 [IL-6], Tumour Necrotising Factor [TNF]-alpha, etc.)<br>