Renal Ultrasound Response After Chocolate Consumption
Switzerland33 participantsStarted 2023-02-22
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Renal Resistive Index (RRI)
Timeframe: baseline versus 2 hours after DC or WC ingestion