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van CCT (UK)

van CCT (UK)

Coffee consumption and glucose tolerance in humans.

- candidate number2731
- NTR NumberNTR1051
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-sep-2007
- Secondary IDs2006.11.020/2946308 
- Public TitleCoffee consumption and glucose tolerance in humans.
- Scientific TitleAcute effects of coffee and major coffee components on glucagon-like peptide 1 response and glucose tolerance in humans.
- ACRONYMKoffiestudie
- hypothesisIntake of chlorogenic acid and trigonelline reduce postprandial glucose concentrations during an oral glucose tolerance test relative to placebo.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Apparently healthy males; Acute effects of coffee and major coffee components on glucagon-like peptide 1 response and glucose tolerance in humans;
2. Age at screening: 18 years and above;
3. Body mass index (BMI) between 25.0 and 35.0 kg/m2;
4. Regular coffee consumer;
5. Willing to restrict coffee consumption during the study to max. 1 cup per day;
6. Voluntary participation;
7. Willing not to be blood or plasmaferese donor from 4 weeks before the start of the study until the end of study.
- Exclusion criteria1. Women;
2. Smokers;
3. Diabetics;
4. Blood sampling is considered too difficult (assessed during pre-study screening);
5. Any chronic or acute disease;
6. Hypertension criteria for moderate hypertension WHO 2003;
7. Medical history or surgical events known to interfere with the study;
8. Alcohol consumption > 28 consumptions per week;
9. Self reported weight loss or gain > 2 kg in the month prior to screening;
10. Any special diet;
11. Participation in any other intervention trial up to 3 months before and during this study;
12. Use of medication known to interfere with the study outcome;
13. Exercising more than 4 hours vigorously per week.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type[default]
- Studytypeintervention
- planned startdate 15-aug-2007
- planned closingdate31-jan-2008
- Target number of participants20
- InterventionsAll participants will receive four treatments in random order, on four different days:
1. Decaffeinated coffee;
2. Chlorogenic acid.
3. Trigonelline.
4. Mannitol (placebo).
All treatments will be ingested before an oral glucose tolerance test. Blood samples will be taken on 7 occasions on each study day. Treatments will be double blind, except for the decaffeinated coffee treatment.
- Primary outcomeGlucose and insulin concentrations in blood
- Secondary outcomeGlucagon-like peptide-1 concentrations and dipeptidyl peptidase IV activity in blood
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdr. ir. Margreet R. Olthof
- CONTACT for SCIENTIFIC QUERIESdr. ir. Rob M. Dam van
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Diabetes Research Fund
- Publications
- Brief summaryHigh coffee consumption is associated with a lower risk of type 2 diabetes. 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. The objective of this study is to test whether chlorogenic acid and trigonelline ingestion acutely reduce postprandial glucose concentrations in humans. The study is a randomized cross-over trial in 20 overweight men including 4 treatments: decaffeinated coffee, chlorogenic acid, trigonelline, and placebo. Acute effects on glucose and insulin responses following an oral glucose tolerance test will be examined.
- Main changes (audit trail)
- RECORD6-sep-2007 - 6-mrt-2008

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