Condition category
Not Specified
Date applied
11/06/2020
Date assigned
02/07/2020
Last edited
02/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.bg-kliniken.de

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

Editorial Notes

02/07/2020: Uploaded protocol Version 1.4, 13 June 2020. 15/06/2020: Trial’s existence confirmed by IRB of the Ärztekammer Berlin