Use of imaging to identify reused seasonal hollow chocolate figurines and prevent their distribution in a hospital setting
| ISRCTN | ISRCTN16847363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16847363 |
| Secondary identifying numbers | CRECHE_V1.4_BGK_11062020 |
- Submission date
- 11/06/2020
- Registration date
- 02/07/2020
- Last edited
- 05/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Not Specified
Plain English summary of protocol
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?
April 2020 to December 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof Dirk Stengel, Dirk.Stengel@bg-kliniken.de
Contact information
Scientific
Leipziger Pl. 1
Berlin
10117
Germany
| Phone | +49 30330960107 |
|---|---|
| dirk.stengel@bg-kliniken.de |
Study information
| Study design | Multi-centre prospective observational study and survey |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Computed tomography to rebut the myth that Easter and Christmas hollow chocolate figurines are reused and are edible safely |
| Study acronym | CRECHE |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2020 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 20 health-care professionals (i.e., doctors, nurses) etc., as well as 20 patients from the two participating institutions |
| Key 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). |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/08/2020 |
| Date of final enrolment | 20/09/2020 |
Locations
Countries of recruitment
- Germany
Study participating centres
Berlin
12683
Germany
Duisburg
47249
Germany
Berlin
10117
Germany
Sponsor information
Hospital/treatment centre
Leipziger Pl. 1
Berlin
10117
Germany
| Phone | +49 1732919577 |
|---|---|
| dirk.stengel@bg-kliniken.de | |
| Website | http://www.bg-kliniken.de |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 24/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | in English version V1.4 |
13/06/2020 | 02/07/2020 | No | No |
| Protocol file | in German version V1.4 |
13/06/2020 | 02/07/2020 | No | No |
| Results article | 13/12/2021 | 14/12/2021 | Yes | No |
Additional files
Editorial Notes
05/03/2025: Internal review.
14/12/2021: Publication reference added.
05/10/2020: The overall trial end date has been changed from 01/10/2020 to 31/12/2020.
02/07/2020: Uploaded protocol Version 1.4, 13 June 2020.
15/06/2020: Trial’s existence confirmed by IRB of the Ärztekammer Berlin
