Hypertension
Conditions
Keywords
cocoa consumption, theobromine, trimethylamine-n-oxide, crossover, randomized trial, chocolate consumption
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.
Interventions
OTHERdark chocolate
Consumption of 100 g/day of 72% dark chocolate bar for 14 days consecutively
OTHERwhite chocolate
Consumption of 80 g/day of white chocolate bar for 14 days consecutively
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Measured at the beginning and the end of each intervention period (14 days) | Office blood pressure measured in the morning after fasting |
| Fasting blood trimethylamine-N-oxide | Measured at the beginning and the end of each intervention period (14 days) | Fasting blood trimethylamine-n-oxide concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial trimethylamine-N-oxide | Measured at the beginning and the end of the dark chocolate intervention (14 days) | Urinary trimethylamine-N-oxide concentrations at 24 and 48 hours after consumption of a test meal (3 boiled eggs) |
| Ankle-brachial index | From the beginning and end of each intervention period of 14 days | Ankle-brachial index is a noninvasive test that measures the ratio of blood pressure in the ankle to the blood pressure in the arm. |
Countries
Thailand
Contacts
PRINCIPAL_INVESTIGATORKongsak Boonyapranai, Doctoral degree
Research Institute for Health Science, Chiang Mai University
Outcome results
None listed