Plain English Summary
Background and study aims
In Germany, and probably other European countries celebrating both Easter and Christmas, it is a widespread urban myth that leftover chocolate Easter bunny figurines are rewrapped in seasonal tin foils simply to be resold as chocolate Santa Clauses (and vice versa).
The German Confectionary Association (BDSI) repeatedly denies this accusation (e.g. https://www.confectionerynews.com/Article/2013/04/16/Chocolate-santas-made-from-Easter-bunnies-denials), as it would be against food and hygiene legislation to reuse already supplied products.
There is, however, limited evidence to prove either the truth of the myth nor its contradiction by the industry. As chocolate Easter bunnies and Santa figurines are common gifts to both health-care professionals and inpatients, scientific information is needed to guarantee they do not contain potentially toxic edibles. Expired chocolate may be "bloomed", indicated by a grey or white film over the surface caused by aged and degraded cocoa fat or sugar. While there is little information that consumption of expired chocolate is harmful, any chance of food poisoning must be minimised, specifically in hospital settings.
Researchers from Manchester showed that computed tomography (CT) is a suitable imaging tool to unveil the internal structure of complex (seasonal) sweets like chocolate rabbits, Kit Kat, or Ferrero Rocher (https://www.cnet.com/news/easter-chocolates-look-gross-in-xray-computer-3d-scans). These results had not been published in a peer-reviewed scientific journal. So far, no study compared the morphometric features of either seasonal (i.e., Easter and Christmas) chocolate figurines which may provide some hint if they had already been on the shelf in the foregone season. We consider the figurines’ shape one of many possible indicators of recycling, as unsold chocolate may also have been melted and again found its way to a casting mould.
Who can participate?
Health care professionals and patients at the trial participating centres
What does the study involve?
Main observational units are Easter Bunny and Santa Clause hollow-chocolate figurines undergoing whole-body computed tomography. In addition, volunteers passing by among main entrances of the trial centres will be approached by research assistants to fill out the 5-item GRINCH questionnaire on personal beliefs about chocolate consumption and safety.
What are the possible benefits and risks of participating?
This study poses nil risk to investigated objects or humans, but also does not promise any benefit to participants.
Where is the study run from?
1. BG Klinikum Unfallkrankenhaus Berlin gGmbH (Germany)
2. BG Klinikum Duisburg (Germany)
3. BG Kliniken - Klinikverbund der gesetzlichen Unfallversicherung gGmbH (Germany)
When is the study starting and how long is it expected to run for?
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof Dirk Stengel, Dirk.Stengel@bg-kliniken.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Dirk Stengel
ORCID ID
Contact details
Leipziger Pl. 1
Berlin
10117
Germany
+49 30330960107
dirk.stengel@bg-kliniken.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CRECHE_V1.4_BGK_11062020
Study information
Scientific title
Computed tomography to rebut the myth that Easter and Christmas hollow chocolate figurines are reused and are edible safely
Acronym
CRECHE
Study hypothesis
1. The belief that reuse and rewrapping of seasonal (hollow) chocolate figurines occurs is false
2. Low-dose CT imaging is a rapid and reliable screening tool to determine whether a shaped chocolate gift may be a remain of its sweet predecessor
3. Potential consumers (both health-care professionals and patients) will consider it safe to taste and eat these figurines once CT precluded it is a reused product
Ethics approval
Approved 11/06/2020, IRB of the Ärztekammer Berlin (Ethik-Kommission, Ärztekammer Berlin, Friedrichstr. 16, 10969 Berlin, Germany; +49 30 40806 2601; stefan@mueller-lissner.de), ref: none
Study design
Multi-centre prospective observational study and survey
Primary study design
Observational
Secondary study design
Epidemiological study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Health implications of reused seasonal chocolate figures
Intervention
A questionnaire will be distributed to both health care professionals and patients to ask for their belief in the urban myth, their willingness to consume chocolate Santas (given the chance they are Easter remains) and any previous exposure to expired seasonal sweets.
Easter and Christmas chocolate figurines will undergo computed tomography with three-dimensional image reconstruction, food chemistry analyses to determine the age of ingredients. Whole-body computed tomography with three-dimensional reconstruction
Intervention type
Other
Phase
Drug names
Primary outcome measure
Contour-Rating Scale (CRS), as assessed by two independent radiologists
Secondary outcome measures
1. Maximal length, breadth and depth the minimum, the mean and maximum thickness of the chocolate mantle, as well the minimum, mean, and maximum thickness of the figurine’s bottom or stand measured (mm) radiologically at a single timepoint
2. Radiation exposure (e.g. volume CT dose index, dose-length-product), scanning time, and time from arrival in the CT suite until the availability of morphologic measures at a single timepoint
3. Health-care professionals’ and patients’ belief in the urban myth that left-over chocolate Easter figurines are rewrapped and sold as Santas, and their willingness to consume chocolate Santas, given CT precluded they had been reused, measured by Likert-scales at a single timepoint
4. Consumption of expired chocolate and symptoms of food-poisoning thereafter measured using a novel questionnaire at a single timepoint
Overall trial start date
01/04/2020
Overall trial end date
01/10/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Survey:
1. Health-care professionals (i.e., doctors, nurses)
2. Patients from the two participating institutions
Radiological measurement:
3. Easter chocolate figurines of different size and shape from various German manufacturers, purchased between April 01 and May 31 2020, and Christmas chocolate figurines of different size and shape from various German manufacturers, to be purchased from their first availability in stores and supermarkets (presumably early September 2020).
Participant type
Mixed
Age group
All
Gender
Both
Target number of participants
20 health-care professionals (i.e., doctors, nurses) etc., as well as 20 patients from the two participating institutions
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/08/2020
Recruitment end date
20/09/2020
Locations
Countries of recruitment
Germany
Trial participating centre
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Warener Str. 7
Berlin
12683
Germany
Trial participating centre
BG Klinikum Duisburg
Großenbaumer Allee 250
Duisburg
47249
Germany
Trial participating centre
BG Kliniken - Klinikverbund der gesetzlichen Unfallversicherung gGmbH
Leipziger Pl. 1
Berlin
10117
Germany
Sponsor information
Organisation
BG Kliniken - Klinikverbund der gesetzlichen Unfallversicherung gGmbH
Sponsor details
Leipziger Pl. 1
Berlin
10117
Germany
+49 1732919577
dirk.stengel@bg-kliniken.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results to be submitted for publication in the BMJ Christmas Issue 2020 or 2021, depending on Editorial interest and decision.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
24/12/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN16847363_PROTOCOL_V1.4_13Jun2020_Deutsch.pdf Uploaded 02/07/2020
- ISRCTN16847363_PROTOCOL_V1.4_13Jun2020_English.pdf Uploaded 02/07/2020