Status:
COMPLETED
Theobromine, Vascular Function and Intestinal apoA-I Production
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Unilever R&D
DSM Nutritional Products, Inc.
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief Summary
Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein (LDL) cholesterol concentrations, a substantial residual cardiovascular risk remains. An additive strategy to f...
Detailed Description
Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein (LDL) cholesterol concentrations, a substantial residual cardiovascular risk remains. An additive strategy to f...
Eligibility Criteria
Inclusion
- Men aged between 45 and 70 years,
- Women aged between 50 and 70 years,
- Serum HDL-C \<1.3 mmol/L (men),
- Serum HDL-C \<1.5 mmol/L (women),
- Serum total cholesterol \<8.0 mmol/L,
- Plasma glucose \<7.0 mmol/L,
- BMI between 25 - 35 kg/m2,
- Non-smoking,
Exclusion
- Unstable body weight (weight gain or loss \>3 kg in the past 3 months),
- Any medical condition requiring treatment and/or medication use,
- Indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus (30),
- Use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism. The use of paracetamol is allowed.
- Active cardiovascular disease (for instance congestive heart failure) or recent (\<6 months) event, such as acute myocardial infarction or cerebro-vascular accident.
- Gastrointestinal diseases (like celiac disease, inflammatory bowel disease, irritable bowel disease and food allergies) or a history of any gastrointestinal disorders or complaints.
- Not willing to stop the consumption of vitamin supplements or fish oil capsules 2 weeks before the start of the study,
- Men: consumption of \>21 glasses of alcohol-containing drinks per week.
- Women: consumption of \>14 glasses of alcohol-containing drinks per week.
- Abuse of drugs,
- Extensive exercise,
- Not willing to abstain from caffeine containing painkillers two weeks prior to the study and the duration of the study,
- Not willing to abstain from theobromine rich products from two weeks prior to the study and the duration of the study:
- o Chocolate containing products (see Appendix A).
- Not willing to abstain from energy drinks from two weeks prior to the study and the duration of the study, because of the high caffeine content.
- Not willing to reduce caffeine containing drinks till maximum 4 drinks a day from two weeks prior to the study and the duration of the study:
- Coffee (excluding coffee without caffeine) (see Appendix A),
- Tea (excluding tea without caffeine) (see Appendix A),
- Cola (see Appendix A).
- Participation in another biomedical study within 1 month prior to the screening visit,
- Having donated \>150 ml blood within 1 month prior to the screening visit, planning to donate blood during the study or within one month after finishing the study.
- Impossible or difficult to puncture as evidenced during the screening visits.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02209025
Start Date
June 1 2014
End Date
September 1 2015
Last Update
September 7 2015
Active Locations (1)
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1
Maastricht University Hospital
Maastricht, Netherlands, 6200 MD