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Cardiovascular Health Effects of Flavanol Rich Chocolate

Cardiovascular Health Effects of Flavanol Rich Chocolate

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01308892
Acronym
CHOC
Enrollment
44
Registered
2011-03-04
Start date
2011-01-31
Completion date
2011-06-30
Last updated
2011-06-17

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

Conditions

Endothelial Dysfunction

Brief summary

In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.

Interventions

DIETARY_SUPPLEMENTHigh flavanol chocolate

chocolate high in flavanols

DIETARY_SUPPLEMENTLow flavanol chocolate

chocolate low in flavanols

DIETARY_SUPPLEMENTHigh fat challenge

Milkshake with 95g fat

Sponsors

Top Institute Food and Nutrition
CollaboratorOTHER
Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
45 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Male * 45-70 years old * BMI between 25 and 32 kg/m2

Exclusion criteria

* Urine glucose concentrations outside normal ranges (\> 0,25 g/l) * Fasting blood glucose \< 7.0 mmol/L) * Systolic Bp \> 160 mmHg or diastolic Bp \> 100 mmHg * Blood Hb values below 8.4 mmol/L * Allergic to cow milk, dairy products or chocolate * Vegetarian * Tobacco smoker * Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)

Design outcomes

Primary

MeasureTime frame
Blood pressure0, 4wk
FMD0, 4wk
PWA0, 4wk

Secondary

MeasureTime frameDescription
Blood pressure0 and 2hacute study part
FMD0 and 2hrsacute study part
leukocyte count and activation0, 4wk
Leukocyte count and activation0 and 2 hrsacute study part
markers of inflammation and ED0 and 2hrsacute study part
PWA0 and 2 hrsacute study part
PBMC gene expression0, 4wk
Markers of inflammation and ED0, 4wk

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026