NCT06820944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 6, 2025

Last Update Submit

March 16, 2026

Conditions

Hypertension

Keywords

cocoa consumptiontheobrominetrimethylamine-n-oxidecrossoverrandomized trialchocolate consumption

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (2)

  • Postprandial trimethylamine-N-oxide

    Measured at the beginning and the end of the dark chocolate intervention (14 days)

  • Ankle-brachial index

    From the beginning and end of each intervention period of 14 days

Study Arms (2)

Dark chocolate

EXPERIMENTAL

100 g/day of dark chocolate

Other: dark chocolate

White chocolate

PLACEBO COMPARATOR

80 g/day of white chocolate

Other: white chocolate

Interventions

dark chocolateOTHER

Consumption of 100 g/day of 72% dark chocolate bar for 14 days consecutively

Dark chocolate
white chocolateOTHER

Consumption of 80 g/day of white chocolate bar for 14 days consecutively

White chocolate

Eligibility Criteria

Age35 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender males and transgender males who do not take female hormones
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute for Health Sciences, Chiang Mai University

Mueang, Chiang Mai, 50200, Thailand

Location

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kongsak Boonyapranai, Doctoral degree

    Research Institute for Health Science, Chiang Mai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 11, 2025

Study Start

February 15, 2025

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)