Glucose metabolism
Conditions
Interventions
This is a randomised, single blind, national, three stage and three group (men, women, and women with gestational diabetes history) clinical trial, which lasts for three months.
Trial
Sponsors
Physiologic Effects of Coffee Committee (PEC) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in this trial subjects must fulfill all of the following criteria: 1. Written informed consent to participate in this trial 2. All drugs which may interfere with glucose metabolism must be discontinued. These include all medication for diabetes, asthma, heart diseases and stomach. Regular non-steroidal anti-inflammatory drug (NSAID) use must also be discontinued. 3. Men and women aged less than 65 years (no lower age limit) 4. Normal fasting insulin level 5. 13 points as a result in the diabetes risk score 6. 7.0 - 12.0 mmol/l as 2-hour blood glucose value in the OGTT
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the trial: 1. Deterioration any of base examination which reveal diabetic state 2. Persons with previous diagnosis of diabetes mellitus 3. Use of drugs, which interfere with glucose metabolism or receiving treatment to lower blood glucose 4. Pregnant women and women who are breast feeding 5. History of malignancy, which needs any therapeutic intervention 6. History of any chronic diseases or other medical characteristics likely to interfere with participation in the study 7. Subjects with imbalanced clinical conditions, such as thyroid and liver diseases, which could interfere with glucose metabolism 8. History of alcohol or drug abuse, or both
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following will be assessed as described in the Interventions field: 1. Incretins 2. Serum cytokines and other inflammatory markers 3. Serum concentrations of polyphenols (caffeic acid and six metabolites of chlorogenic acid and caffeic acid, including their methylated and hydrated forms), caffeine, and the caffeine metabolite paraxanthine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dietary assessment: at the end of each stage subjects fill three-day food diary to assess the normal intake of chlorogenic acid 2. Physical examination: a detailed medical history, including family history of diabetes, alcohol intake, use of any medications, as well as coronary heart disease (CHD) will be recorded | — |
Countries
Finland
Outcome results
None listed