Effects of Dark Chocolate on the Risk Factors of Cardiovascular Diseases
1 other identifier
interventional
45
1 country
1
Brief Summary
Cardiovascular disease (CVD) is the number one cause of death in the US. Epidemiologic evidence supports that antioxidant-rich diets promote health and attenuate or delay the onset of CVD. Cocoa and chocolate products have among the highest antioxidant concentrations compared to other antioxidant food sources. The objective of this study is to examine the effects of regular dark chocolate, bloomed dark chocolate, and white chocolate on cardiovascular health markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Apr 2011
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 28, 2025
CompletedFirst Posted
Study publicly available on registry
February 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 5, 2026
February 1, 2026
15.8 years
January 28, 2025
February 3, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Change of systolic and diastolic blood pressure
Change of systolic and diastolic blood pressure will be determined to examine effects of dark chocolate consumption vs white chocolate.
Baseline and Day 15
Change of skin blood flow level
Change of skin blood flow level will be determined using Laser Doppler Flowmetry to examine effects of dark chocolate consumption vs white chocolate. Laser Doppler flowmetry is an optical technology widely used in research to measure blood flow. It is a non-invasive, painless technique for studying microcirculatory changes in tissue.
Baseline and Day 15
Change of HDL cholesterol level
Change of blood cholesterol level will be determined to examine effects of dark chocolate consumption vs white chocolate.
Baseline and Day 15
Change of antioxidant levels
Change of antioxidant levels will be determined to examine effects of dark chocolate consumption vs white chocolate.
Baseline and Day 15
Study Arms (2)
White chocolate
ACTIVE COMPARATORSubjects consume 50g of white chocolate daily for 15 days.
Dark chocolate
EXPERIMENTALSubjects consume 50g of dark chocolate daily for 15 days.
Interventions
To determine the effects of dark chocolate consumption on risk factors of cardiovascular diseases
To determine the effects of white chocolate consumption on risk factors of cardiovascular diseases
Eligibility Criteria
You may qualify if:
- Generally healthy subjects
You may not qualify if:
- Smoker
- Pregnant woman
- Lactose intolerance
- Required dietary supplement use
- Required medication of metabolic disorders
- Allergy to cacao
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Diego State University
San Diego, California, 92182, United States
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2025
First Posted
February 5, 2025
Study Start
April 1, 2011
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
De-identified individual participant data collected in this study are used exclusively within the primary research group and will not be shared with other external researchers.