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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85096812

Enrollment

Registered

2007-11-06

Start date

2007-10-01

Completion date

Unknown

Last updated

2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular and metabolic diseases Nutritional, Metabolic, Endocrine Metabolic diseases

Interventions

Participants will receive on two occasions with a random and blind order respectively a cup of caffeinated coffee and a cup of decaffeinated coffee (a standardised cup of 25 ml Italian expresso) with

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Amendment as of 15/05/2008: Please note that the primary outcome measure was assessed in only 20 participants. 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.	—

Measure

Time frame

Amendment as of 15/05/2008: Please note that the primary outcome measure was assessed in only 20 participants. 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.

—

Secondary

Measure	Time frame
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. 1. Intra-renal haemodynamic measurements (resistance and pulsatility indexes), obtained before and 60 minutes after coffee ingestion in both occasions 2. Blood pressure, obtained before and 60 minutes after coffee ingestion in both occasions 3. Electrocardiogram with QTc interval measurement, obtained before and 60 minutes after coffee ingestion in both occasions 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.)	—

Measure

Time frame

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. 1. Intra-renal haemodynamic measurements (resistance and pulsatility indexes), obtained before and 60 minutes after coffee ingestion in both occasions 2. Blood pressure, obtained before and 60 minutes after coffee ingestion in both occasions 3. Electrocardiogram with QTc interval measurement, obtained before and 60 minutes after coffee ingestion in both occasions 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.)

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026