Theobromine from Cocoa and Cardiovascular Risk Factors

Not Applicable

Recruiting

• Conditions: Hypertension

• Registration Number: NCT06820944
• Lead Sponsor: Chiang Mai University

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-02-15
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Fasting blood trimethylamine-N-oxide	Measured at the beginning and the end of each intervention period (14 days)	Fasting blood trimethylamine-n-oxide concentrations
Blood pressure	Measured at the beginning and the end of each intervention period (14 days)	Office blood pressure measured in the morning after fasting

Secondary Outcome Measures

Name	Time	Method
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.
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)

Trial Locations

Locations (1)

Research Institute for Health Sciences, Chiang Mai University; 🇹🇭 Mueang, Chiang Mai, Thailand