NCT06808282

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
8mo left

Started Apr 2011

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Apr 2011Dec 2026

Study Start

First participant enrolled

April 1, 2011

Completed
13.8 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

15.8 years

First QC Date

January 28, 2025

Last Update Submit

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 COMPARATOR

Subjects consume 50g of white chocolate daily for 15 days.

Other: White chocolate

Dark chocolate

EXPERIMENTAL

Subjects consume 50g of dark chocolate daily for 15 days.

Other: Dark chocolate

Interventions

To determine the effects of dark chocolate consumption on risk factors of cardiovascular diseases

Dark chocolate

To determine the effects of white chocolate consumption on risk factors of cardiovascular diseases

White chocolate

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Cardiovascular Diseases

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.

Locations