NCT07556627

Brief Summary

This randomized controlled crossover trial investigates the acute effects of consuming dark, milk, and white chocolate before prolonged sitting on cardiovascular health in healthy adults. Each participant completes three separate study visits and receives all three chocolate conditions in a randomized order, with a 7-day washout period between visits. Blood pressure, heart rate, pulse wave velocity, blood glucose, appetite, pain, and calf circumference are measured before and during a 3-hour sitting perio

Trial Health

77
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Apr 2026Dec 2026

Study Start

First participant enrolled

April 4, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 22, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Dark ChocolateMilk ChocolateWhite ChocolateProlonged SittingBlood PressurePulse Wave VelocityHeart Rate Variability

Outcome Measures

Primary Outcomes (4)

  • Blood Pressure (Systolic, Diastolic, Mean Arterial Pressure)

    Blood pressure will be measured using an automated sphygmomanometer under each chocolate condition (dark, milk, white).

    Baseline, 1 hour post-chocolate, and hourly during 3 hours of prolonged sitting

  • Pulse Wave Velocity

    Arterial stiffness will be assessed using estimated pulse wave velocity under each chocolate condition.

    Baseline, 1 hour post-chocolate, and hourly during 3 hours of prolonged sitting

  • Heart Rate Variability

    Autonomic cardiac function will be assessed using heart rate variability derived from RR interval recordings under each chocolate condition.

    Baseline, 1 hour post-chocolate, and hourly during 3 hours of prolonged sitting

  • Heart Rate

    Heart rate will be measured under each chocolate condition during the study visits.

    Baseline, 1 hour post-chocolate, and hourly during 3 hours of prolonged sitting.

Secondary Outcomes (4)

  • Capillary Blood Glucose

    Baseline, 1 hour post-chocolate, and hourly during 3 hours of prolonged sitting

  • Appetite Visual Analog Scale

    Baseline, 1 hour post-chocolate, and hourly during 3 hours of prolonged sitting

  • Pain Visual Analog Scale

    Baseline, 1 hour post-chocolate, and hourly during 3 hours of prolonged sitting

  • Calf Circumference

    Baseline and hourly during 3 hours of prolonged sitting

Study Arms (3)

Label: Dark Chocolate

EXPERIMENTAL

Participants receive dark chocolate prior to prolonged sitting.

Dietary Supplement: dark chocolate

Label: Milk Chocolate

EXPERIMENTAL

Participants receive milk chocolate prior to prolonged sitting.

Dietary Supplement: Milk Chocolate

Label: White Chocolate

EXPERIMENTAL

Participants receive white chocolate prior to prolonged sitting.

Dietary Supplement: White Chocolate

Interventions

dark chocolateDIETARY_SUPPLEMENT

Participants consume dark chocolate 1 hour before prolonged sitting.

Label: Dark Chocolate
Milk ChocolateDIETARY_SUPPLEMENT

Participants consume milk chocolate 1 hour before prolonged sitting.

Label: Milk Chocolate
White ChocolateDIETARY_SUPPLEMENT

Participants consume white chocolate 1 hour before prolonged sitting.

Label: White Chocolate

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult males and females aged between 18 and 40 years.
  • Participants with blood pressure within the normal or elevated range (less than 130/80 mmHg), according to the American Heart Association guidelines.

You may not qualify if:

  • Females with menopause will be excluded due to the physiological effects of menopause and to ensure hormonal stability.
  • Participants with nut allergies, due to the possibility that the chocolate used may contain traces of nuts resulting from manufacturing processes.
  • Participants with dairy allergies, due to the use of milk chocolate and white chocolate, and the possibility that dark chocolate may contain traces of milk resulting from manufacturing processes .
  • Participants with chronic diseases that may affect the study variables, such as cardiovascular diseases, respiratory diseases, diabetes, or any medical condition that affects circulation.
  • Participants using medications that may affect the targeted physiological measurements in the study, such as antihypertensive medications, antidiabetic medications, or drugs affecting the autonomic nervous system.
  • Participants with a body mass index (BMI) ≥ 30 kg/m², due to the association between obesity and vascular dysfunction, characterized by increased blood pressure and arterial stiffness, which may lead to variability in vascular responses.
  • Participants who are physically active (≥150 minutes per week of moderate-to-vigorous physical activity), to avoid the impact of high levels of training on vascular responses.
  • Smokers, due to the chronic effects of smoking on endothelial function and arterial stiffness.
  • Participants with back injuries that limit their ability to sit continuously for three hours.
  • Female participants who are pregnant, breastfeeding, due to the associated hormonal changes that may influence the physiological indicators measured in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Physiology Laboratory, King Saud University

Riyadh, Riyadh Region, 11451, Saudi Arabia

RECRUITING

Study Officials

  • Abdullah B Alansare, PhD

    King Saud University

    STUDY DIRECTOR

Central Study Contacts

Razan S Alahmadi, MSc Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Each participant receives all three chocolate conditions (dark, milk, and white chocolate) in randomized order across three separate visits with a 7-day washout period between visits.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2026

First Posted

April 29, 2026

Study Start

April 4, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations