Theobromine from Cocoa and Cardiovascular Risk Factors

Chiang Mai University

Status: Enrolling

Conditions: Hypertension

Treatments: Other: dark chocolate; Other: white chocolate

Study type: Interventional

Funder types: Other

Identifiers

NCT06820944

21/67

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 estimated patients

Sex: Male

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups, including a placebo group

Dark chocolate

Experimental group

Description:

100 g/day of dark chocolate

Treatment:

Other: dark chocolate

White chocolate

Placebo Comparator group

Description:

80 g/day of white chocolate

Treatment:

Other: white chocolate