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Completed

NCT Number: NCT05755217

Renal Ultrasound Response After Chocolate Consumption

The consumption of dark chocolate (DC) has antihypertensive (3) and anti-inflammatory effects. Some studies also suggest that dark chocolate may also have cardiovascular benefits, but its physiological effects on the kidneys have not been studied in detail.

In this randomized, single-blinded, controlled, monocentric cross-over study we will investigate whether the ingestion of a single dose of dark chocolate (g/kg, max 70g) leads to alterations in renal perfusion and blood pressure two hours after its consumption in healthy volunteers and patients suffering from chronic kidney disease.

The Doppler-ultrasound assessed renal resistive index (RRI) will be used at baseline and two hours after chocolate consumption as an indirect measure of renal perfusion. Blood pressure and heart rate will be measured continuously using the Finapres® NOVA (Finapres Medical Systems, Enschede, The Netherlands) throughout the Doppler ultrasound examination.

In order to compare the effects of dark chocolate with those obtained with white chocolate, participants will undergo a similar sequence of exames after the consumption of white chocolate.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nephrology, Centre Hospitalier Universitaire Vaudois, Lausanne, Canton of Vaud, Switzerland

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About this study

Many studies have been carried out to investigate the possible effects of dark chocolate on our body.

Especially dark chocolate (DC) has been studied because it contains large quantities of cocoa and flavonoids. Regular cocoa consumption (dark chocolate) has antihypertensive and anti-inflammatory effects. A previous study demonstrated that dark chocolate may also have cardiovascular benefits. Their study showed that the consumption of DC (70% cocoa) induces vasodilation of the coronary arteries. In a cross-over study performed in 2013 by the PI of this study, dark chocolate (containing 70% cocoa) improved kidney oxygenation as assessed with renal MRI in healthy people two hours after its ingestion, whereas white chocolate did not induce any changes. The reasons for this increase remained hypothetical, as other aspects of renal physiology such as renal perfusion were not measured in this study. Chocolate intake also has potential side effects. As it is rich in calories and carbohydrates, long term, regular intake may lead to weight gain and its associated problems. Besides, the hemodynamic effects on DC intake in patients suffering from chronic kidney diseases (CKD) are also largely unknown. Hence, more insight in the renal physiological effects of DC intake is needed before any recommendation can be made on the potential usefulness of randomized controlled trials to test short-and long-term renal effects of DC intake.

Renal physiology, especially perfusion, can be monitored using renal ultrasound thanks to its Doppler mode. In particular, the renal resistive index (RRI) of intra-renal segmentary arteries is an interesting parameter in this context. RRI is defined as the difference between maximum systolic and minimum diastolic velocity divided by the maximum systolic velocity. RRI stands for the resistance that blood faces when passing through the kidneys. From a physiological viewpoint, vasoconstriction of intra-renal segmentary and interlobar arteries will increase RRI, whereas vasodilation of the main renal arteries will decrease the RRI. As chocolate induce vasodilatation of arteries, RRI is expected to decrease after DC intake.

Renal perfusion is also affected by the sympathetic nervous system, as its activation generates vasoconstriction of peripherical arteries, and possibly of the renal arteries. The handgrip test is a way to activate the sympathetic nervous system. With this test, volunteer applies an isometric strength with his hand to a handgrip device, which activates the sympathetic nervous system. . Therefore, the handgrip test can there be seen as a renal vascular stress test, but its effects on the RRI have not been studied. Besides, whether the RRI is influenced by the hand grip test, and whether this change is altered by DC intake, is also unknown. The handgrip test will therefore be used in the present study.

The aim of the present randomized controlled trial study is to investigate changes that may occur in kidneys after eating white and dark chocolate, as well as to see how renal perfusion works in this context and to evaluate responses to renal vascular stress (handgrip test). The innovation of the present study stands in the fact that the effect of chocolate intake on renal physiology has, to the best of our knowledge, not been investigated using renal ultrasound. It is also unknown whether the intake of chocolate may balance the renal physiology changes in response to stress (i.e. handgrip test).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for healthy volunteers:

  • Age ≥ 18 years old
  • ability to understand the study protocol and to sign an informed consent.

Inclusion criteria

for CKD patients:

  • Age ≥18 years old,
  • CKD stage 1-3,
  • ability to understand the study protocol and to sign an informed consent

Exclusion criteria

  • Lactose or cocoa intolerance,
  • Diabetes,
  • any severe digestive issue and liver disease,
  • history of kidney stones,
  • inability to follow the procedures of the study, e.g. due to language problems, dementia, etc.
  • pregnant women
  • healthy volunteers taking antihypertensive medication
  • healthy volunteers having a known kidney malformation or abnormality
  • healthy volunteers with albuminuria and/or hematuria in the urine sample.
  • CKD patients with an eGFR<30ml/min/1.73m2
  • CKD patients with measured kalemia of > 5.5mmol/l in the last three months.

Treatment and study plan

Dark chocolate

Dietary Supplement

Single oral dose of 1g/kg of dark chocolate (70% cocoa).

White chocolate

Dietary Supplement

Single oral dose of 1g/kg of white chocolate (4% cocoa).

Primary outcomes

  1. Renal Resistive Index (RRI)

    Time frame: baseline versus 2 hours after DC or WC ingestion

    assess the differences in Doppler ultrasound- assessed RRI depending on the type of chocolate eaten by participants

Secondary outcomes

  1. Peak Systolic Velocity (PSV)

    Time frame: baseline versus 2 hours after DC or WC ingestion

    assess the differences in Doppler-ultrasound assessed PSV depending on the type of chocolate eaten by participants

  2. Peak Diastolic Velocity (PDV)

    Time frame: baseline versus 2 hours after DC or WC ingestion

    assess the differences in Doppler-ultrasound assessed PDV depending on the type of chocolate eaten by participants

  3. Pulsatility Index (PuI)

    Time frame: baseline versus 2 hours after DC or WC ingestion

    assess the differences in Doppler-ultrasound assessed PuI depending on the type of chocolate eaten by participants

  4. Systolic Blood Pressure (SBP)

    Time frame: baseline versus 2 hours after DC or WC ingestion

    assess the differences in Finapress-assessed SBP depending on the type of chocolate eaten by participants

  5. Diastolic Blood Pressure (DBP)

    Time frame: baseline versus 2 hours after DC or WC ingestion

    assess the differences in Finapress-assessed DBP depending on the type of chocolate eaten by participants

  6. Mean Arterial Pressure (MAP)

    Time frame: baseline versus 2 hours after DC or WC ingestion

    assess the differences in Finapress-assessed MAP depending on the type of chocolate eaten by participants

  7. Handgrip-induced changes in RRI

    Time frame: baseline versus 2 hours after DC or WC ingestion

    assess the differences in handgrip-induced change in RRI depending on the type of chocolate eaten by participants

Sponsors and collaborators

Lead sponsor

Gregoire Wuerzner; MD

Other

Registry information

Official study title

Study of the Renal Physiological Response After Chocolate Consumption

Acronym: Choco

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2023
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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