To test whether chlorogenic acid and trigonelline ingestion acutely reduce postprandial glucose concentrations in humans. In addition, we will examine whether effects on glucagon-like peptide 1 secretion and dipeptidyl peptidase IV inhibition are…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Concentrations of glucose, insulin, glucagon-like peptide 1 secretion, and the
activity of dipeptidyl peptidase IV will be measured during 2 hours following
an oral glucose tolerance test.
Secondary outcome
N.A.
Background summary
High coffee consumption is associated with a lower risk of type 2 diabetes in
prospective cohort studies in the U.S., Europe and Japan. Similar associations
are observed for caffeinated and decaffeinated coffee, suggesting that coffee
components other than caffeine have beneficial effects on glucose homeostasis.
Chlorogenic acid and trigonelline are major components in coffee and may be
partly responsible for improved glucose tolerance following coffee consumption.
Administration of these substances decreased glucose levels in animal studies,
but there are no studies in humans.
Study objective
To test whether chlorogenic acid and trigonelline ingestion acutely reduce
postprandial glucose concentrations in humans. In addition, we will examine
whether effects on glucagon-like peptide 1 secretion and dipeptidyl peptidase
IV inhibition are responsible for beneficial effects on glucose tolerance.
Study design
Double-blind, placebo controlled, cross-over trial
Intervention
Each subject will be randomly assigned to one out of 24 treatment orders.
The four interventions are:
1) 0.5 L decaffeinated coffee (2 large cups)
2) ~1,000 mg chlorogenic acid (comparable to 1.0-2.0 L of strong coffee)
3) ~500 mg trigonelline (comparable to 0.5-1.0 L of strong coffee)
4) ~1,000 mg mannitol (placebo).
Study burden and risks
The procedures the participants will undergo:
- Single intake of supplements of dietary components. Subjects in this study
will be regular consumers of coffee and therefore the subjects consume these
compounds on a daily basis.
- Blood withdrawal through a catheter in the antecubital vein. This is a very
common procedure and its risk is considered low.
Therefore, the proposed study does not impose a large burden on the
participants. There will not be any direct medical benefits for the
participants. Eventually, the identification of coffee components with
beneficial effects on glucose metabolism could lead to the development or
selection of coffee types, or other foods with high levels of these substances
which contribute to the prevention of type 2 diabetes.
de Boelelaan 1085
1081 HV Amsterdam
Nederland
de Boelelaan 1085
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Apparently healthy males as assessed by the questionnaires during the pre-study visit, and the results of the pre-study clinical laboratory tests and urinalysis
- Age at screening: 18 years and above
- Body mass index (BMI) between 25.0 and 35.0 kg/m2
- Regular coffee consumer (1 cup per day or more)
- Willing to restrict coffee consumption during the study to max. 1 cup per day
- Voluntary participation
- Willing not to be blood or plasmaferese donor from 4 weeks before the start of the study until the end of study
Exclusion criteria
- Women
- Smokers
- Subjects with diabetes will be excluded (fasting blood glucose >= 7.0 mmol/l or physician-diagnosis of diabetes)
- Blood sampling is considered too difficult (assessed during pre-study screening)
- Any chronic or acute disease (e.g. diabetes, renal disease, inflammation, cardiovascular disease). Therefore the medical questionnaire will be evaluated by a doctor from the research team.
- Hypertension criteria for moderate hypertension WHO 2003: systolic > 140 mmHg or diastolic > 90 mmHg
- Medical history or surgical events known to interfere with the study
- Alcohol consumption > 28 consumptions per week
- Self reported weight loss or gain > 2 kg in the month prior to screening
- Any special diet (prescribed, slimming, macrobiotic or vegan). Sole exclusion of meat and fish from an otherwise *normal* western diet is allowed
- Participation in any other trial up to 3 months before and during this study
- Use of medication known to interfere with the study outcome e.g.: Medication interfering with digestion or glucose metabolism, such as corticosteroids and beta-blockers
- Exercising more than 4 hours vigorously per regular week
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17481.029.07 |