Renal Ultrasound Response After Chocolate Consumption

NCT05755217 | Recruiting DMC

• 1 other identifier: 2022-01359
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chocolate Consumption

Keywords

chronic kidney disease; doppler ultrasound; renal resistive index; handgrip test; dark chocolate; white chocolate; cocoa

Outcome Measures

Primary Outcomes (1)

• Renal Resistive Index (RRI)

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

  baseline versus 2 hours after DC or WC ingestion

Secondary Outcomes (7)

• Peak Systolic Velocity (PSV)

  baseline versus 2 hours after DC or WC ingestion

• Peak Diastolic Velocity (PDV)

  baseline versus 2 hours after DC or WC ingestion

• Pulsatility Index (PuI)

  baseline versus 2 hours after DC or WC ingestion

• Systolic Blood Pressure (SBP)

  baseline versus 2 hours after DC or WC ingestion

• Diastolic Blood Pressure (DBP)

  baseline versus 2 hours after DC or WC ingestion

Study Arms (2)

Dark chocolate

ACTIVE COMPARATOR

Single dose of 1g/kg of dark chocolate (70% cocoa, Lindt Excellence)

Dietary Supplement: Dark chocolate

White chocolate

PLACEBO COMPARATOR

Single dose of 1g/kg of white chocolate (4% cocoa, Nestle Galak).

Dietary Supplement: White chocolate

Interventions

Dark chocolate DIETARY_SUPPLEMENT

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

Dark chocolate

White chocolate DIETARY_SUPPLEMENT

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

White chocolate

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gregoire Wuerzner; MD: lead

Study Sites (2)

Department of Nephrology, Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

University Hospital of Lausanne (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (5)

• Grassi D, Necozione S, Lippi C, Croce G, Valeri L, Pasqualetti P, Desideri G, Blumberg JB, Ferri C. Cocoa reduces blood pressure and insulin resistance and improves endothelium-dependent vasodilation in hypertensives. Hypertension. 2005 Aug;46(2):398-405. doi: 10.1161/01.HYP.0000174990.46027.70. Epub 2005 Jul 18.

  PMID: 16027246 BACKGROUND

• Fanton S, Cardozo LFMF, Combet E, Shiels PG, Stenvinkel P, Vieira IO, Narciso HR, Schmitz J, Mafra D. The sweet side of dark chocolate for chronic kidney disease patients. Clin Nutr. 2021 Jan;40(1):15-26. doi: 10.1016/j.clnu.2020.06.039. Epub 2020 Jul 14.

  PMID: 32718711 BACKGROUND

• Flammer AJ, Hermann F, Sudano I, Spieker L, Hermann M, Cooper KA, Serafini M, Luscher TF, Ruschitzka F, Noll G, Corti R. Dark chocolate improves coronary vasomotion and reduces platelet reactivity. Circulation. 2007 Nov 20;116(21):2376-82. doi: 10.1161/CIRCULATIONAHA.107.713867. Epub 2007 Nov 5.

  PMID: 17984375 BACKGROUND

• Buijsse B, Feskens EJ, Kok FJ, Kromhout D. Cocoa intake, blood pressure, and cardiovascular mortality: the Zutphen Elderly Study. Arch Intern Med. 2006 Feb 27;166(4):411-7. doi: 10.1001/archinte.166.4.411.

  PMID: 16505260 BACKGROUND

• Pruijm M, Hofmann L, Charollais-Thoenig J, Forni V, Maillard M, Coristine A, Stuber M, Burnier M, Vogt B. Effect of dark chocolate on renal tissue oxygenation as measured by BOLD-MRI in healthy volunteers. Clin Nephrol. 2013 Sep;80(3):211-7. doi: 10.5414/CN107897.

  PMID: 23557792 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Menno Pruijm, PD MD

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Menno Pruijm, PD MD

CONTACT

+41795565946; menno.pruijm@chuv.ch

Wendy Brito, radiological technician

CONTACT

+41795561935; wendy.brito@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The sonographer will be blinded for the study intervention (eg, dark or white chocolate consumption)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Grégoire Wuerzner

Model Details: This study will be a single-blinded randomized cross-over study, comparing the renal physiological effects of dark chocolate (DC) with white chocolate (WC). Doppler ultrasounds will take place in the Service of Nephrology of the CHUV, between late morning and early afternoon. Healthy participants who meet the inclusion criteria will be divided in small groups of 3-4 persons according to the order of inclusion. CKD participants will be investigated separately. Every participant will sign an informed consent form before the beginning of the study

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: February 22, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CH (2)