Theobromine From Cocoa and Cardiovascular Risk Factors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-09-30

Brief Summary

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The goal of this clinical trial is to examine whether consumption of dark chocolate affects blood pressure and a cardiovascular risk factor called trimethylamine N-oxide in Thai male participants with hypertension. The main questions it aims to answer are:

Can consumption of dark chocolate lower blood pressure? Can consumption of dark chocolate lower blood trimethylamine N-oxide?

Researchers will compare dark chocolate to white chocolate to see if the effects are due to theobromine (a key bioactive compound in dark chocolate).

Participants will consume either 100 g 72% dark chocolate bar or 80 g white chocolate bar daily for 14 days, rest for 7 days, and then switch to the other type of chocolate.

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Detailed Description

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This is a randomized cross-over trial conducted in Chiang Mai, Thailand. The goal of this clinical trial is to examine whether consumption of dark chocolate affects cardiovascular risk factors, with the primary outcomes being blood pressure and a cardiovascular risk factor called trimethylamine N-oxide. Participants are Thai males aged 35-70 years with hypertension who live in the Chiang Mai area.

42 Participants will consume either 100 g 72% dark chocolate bar (\~2.5 servings, providing \~900 mg theobromine) or 80 g white chocolate bar (\~2 servings, providing 0 mg theobromine) daily for 14 days. After a 7-day wash-out period, the participant will repeat the protocol with the other intervention.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dark chocolate

100 g/day of dark chocolate

Group Type EXPERIMENTAL

dark chocolate

Intervention Type OTHER

Consumption of 100 g/day of 72% dark chocolate bar for 14 days consecutively

White chocolate

80 g/day of white chocolate

Group Type PLACEBO_COMPARATOR

white chocolate

Intervention Type OTHER

Consumption of 80 g/day of white chocolate bar for 14 days consecutively

Interventions

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dark chocolate

Consumption of 100 g/day of 72% dark chocolate bar for 14 days consecutively

Intervention Type OTHER

white chocolate

Consumption of 80 g/day of white chocolate bar for 14 days consecutively

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male
* Age between 35 to 70 years
* BMI less than 30 kg/m\^2
* Systolic blood pressure between 130 to 159 mmHg or Diastolic blood pressure between 85 to 99 mmHg.
* Do not smoke.

Exclusion Criteria

* Cannot drink beverages and consume foods that have caffeine.
* Take medicine to lower cholesterol and triglyceride levels, treat high blood pressure, or diabetes.
* Have liver and kidney inflammation.
* Use antibiotics within 1 month of study.
* Use choline or probiotic supplements regularly within 1 month of study.
* Consume more than 30 alcoholic drinks per week.
* Have chronic diseases.

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No