Dose dependent acute effects of decaffeinated coffee on endothelial function and glucose metabolism in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41583899

Enrollment

Registered

2008-05-22

Start date

2008-04-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Cardiovascular and metabolic diseases/ clinical nutrition Nutritional, Metabolic, Endocrine N/A

Interventions

This is a cross-over, randomised trial. Participants will receive, on two occasions in random order, one or two cups of decaffeinated coffee (a standardised cup of 25 ml Italian expresso) at one wee

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
1. Fasting acute effects of the two different doses of coffee on endothelial function, measured as the flow mediated dilation (FMD). FMD measurements (outcome assessors blinded) will be performed before, 30 and 60 minutes after coffee ingestion. 2. Fasting acute effects of the two different doses of coffee on glucose metabolism, evaluated on the basis of blood concentrations of glucose, insulin and c-peptide. These blood measurements will be obtained before and 60 minutes after coffee ingestion.	—

Measure

Time frame

1. Fasting acute effects of the two different doses of coffee on endothelial function, measured as the flow mediated dilation (FMD). FMD measurements (outcome assessors blinded) will be performed before, 30 and 60 minutes after coffee ingestion. 2. Fasting acute effects of the two different doses of coffee on glucose metabolism, evaluated on the basis of blood concentrations of glucose, insulin and c-peptide. These blood measurements will be obtained before and 60 minutes after coffee ingestion.

—

Secondary

Measure	Time frame
1. Blood pressure, obtained before, 30 and 60 minutes after coffee ingestion 2. Heart rate, measured continuously for the entire duration of the test (60 min) 3. Electrocardiogram with QTc interval measurement, obtained before and 60 minutes after coffee ingestion 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 future measurements (Interleukin-6 [IL-6], tumour necrosis factor-alpha [TNF-alpha], etc.)	—

Measure

Time frame

1. Blood pressure, obtained before, 30 and 60 minutes after coffee ingestion 2. Heart rate, measured continuously for the entire duration of the test (60 min) 3. Electrocardiogram with QTc interval measurement, obtained before and 60 minutes after coffee ingestion 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 future measurements (Interleukin-6 [IL-6], tumour necrosis factor-alpha [TNF-alpha], etc.)

—

Countries

Italy

Outcome results

None listed

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