Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dark chocolate | Experimental | 100 g/day of dark chocolate |
|
| White chocolate | Placebo Comparator | 80 g/day of white chocolate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dark chocolate | Other | Consumption of 100 g/day of 72% dark chocolate bar for 14 days consecutively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Office blood pressure measured in the morning after fasting | Measured at the beginning and the end of each intervention period (14 days) |
| Fasting blood trimethylamine-N-oxide | Fasting blood trimethylamine-n-oxide concentrations | Measured at the beginning and the end of each intervention period (14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial trimethylamine-N-oxide | Urinary trimethylamine-N-oxide concentrations at 24 and 48 hours after consumption of a test meal (3 boiled eggs) | Measured at the beginning and the end of the dark chocolate intervention (14 days) |
| Ankle-brachial index |
Not provided
Inclusion criteria
Exclusion criteria
Cisgender males and transgender males who do not take female hormones
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kongsak Boonyapranai, Doctoral degree | Research Institute for Health Science, Chiang Mai University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute for Health Sciences, Chiang Mai University | Mueang | Chiang Mai | 50200 | Thailand |
Not provided
| Label | URL |
|---|---|
| Chocolate consumption and cardiometabolic disorders: systematic review and meta-analysis. BMJ, 343(7825). | View source |
| The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193-213. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| white chocolate | Other | Consumption of 80 g/day of white chocolate bar for 14 days consecutively |
|
Ankle-brachial index is a noninvasive test that measures the ratio of blood pressure in the ankle to the blood pressure in the arm. |
| From the beginning and end of each intervention period of 14 days |
| Effect of dark chocolate on flow-mediated dilatation: Systematic review, meta-analysis, and dose-response analysis of randomized controlled trials. Clinical Nutrition ESPEN, 36, 17-27. |
| View source |
| 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. In Circulation (Vol. 139, | View source |
| Effects of chocolate, cocoa, and flavan-3-ols on cardiovascular health: a systematic review and meta-analysis of randomized trials. The American Journal of Clinical Nutrition, 95(3), 740-751. | View source |
| Impact of cocoa flavanols on human health. Food and Chemical Toxicology, 151, 112121. | View source |
| Effect of cocoa and theobromine consumption on serum HDL-cholesterol concentrations: A randomized controlled trial. American Journal of Clinical Nutrition, 97(6), 1201-1209. | View source |
| (2016). Relationship of Serum Trimethylamine N-Oxide (TMAO) Levels with early Atherosclerosis in Humans. Scientific Reports, 6(1), 26745. | View source |
| (2019). Chocolate consumption and risk of cardiovascular diseases: a meta-analysis of prospective studies. Heart, 105(1), 49-55. | View source |
| Dose-response relationship between cocoa flavanols and human endothelial function: a systematic review and meta-analysis of randomized trials. Food \& Function, 10(10), 6322-6330. | View source |
| ). Effects of cocoa products/dark chocolate on serum lipids: a meta-analysis. European Journal of Clinical Nutrition 2011 65:8, 65(8), 879-886. | View source |