Clinical trial NCT06820944: Theobromine From Cocoa and Cardiovascular Risk Factors
Official title: Theobromine Consumption From Cocoa and Cardiovascular Risk Factors in Humans: Evidence for Health Claims
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: cocoa consumption
theobromine
trimethylamine-n-oxide
crossover
randomized trial
chocolate consumption
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 42
Sex: MALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Blood pressure
timeFrame: Measured at the beginning and the end of each intervention period (14 days)
measure: Fasting blood trimethylamine-N-oxide
timeFrame: Measured at the beginning and the end of each intervention period (14 days)
Secondary outcomes:
measure: Postprandial trimethylamine-N-oxide
timeFrame: Measured at the beginning and the end of the dark chocolate intervention (14 days)
measure: Ankle-brachial index
timeFrame: From the beginning and end of each intervention period of 14 days
Other outcomes:
Locations:
city: Mueang
country: Thailand
facility: Research Institute for Health Sciences, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Research Institute for Health Science, Chiang Mai University
name: Kongsak Boonyapranai, Doctoral degree
role: PRINCIPAL_INVESTIGATOR
References: