Eating habits during the Covid-19 pandemic

Organizational Data

DRKS-ID:
DRKS00022514
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2020-12-03
Last update in DRKS:
2022-04-13
Registration type:
Prospective

Acronym/abbreviation of the study

MeDiCo- health Study

URL of the study

https://medico-health.de/medico

Brief summary in lay language

Healthy eating has many facets and external factors, such as the current pandemic, influence eating behaviour. In the "enable cluster" we were able to collect comprehensive data on the nutritional status and eating behavior before the pandemic. This now gives us the opportunity to re-evaluate these enable cohorts with the same tools to assess the change before and during the pandemic. Besides possibly changing nutritional patterns, we want to focus on the micronutrient status. An important property of micronutrients, such as selenium, vitamin D or zinc, is their role in the immune system. A number of studies have already established a connection between certain micronutrient deficiencies and the risk of bacterial and viral infections. For this reason, SARS-CoV-2-positive patients (symptomatic and asymptomatic) are now to be recruited in this study to examine symptomatic and asymptomatic patients for differences in dietary behaviour and their micronutrient status (selenium, vitamin D and zinc). Nutritional behavior will be determined by means of validated online questionnaires and the micronutrient status will be tested by means of a finger blood sample.

Brief summary in scientific language

Unhealthy eating habits in modern societies are potentially modulating factors for a variety of diseases. At all stages of life, nutrition is subject to changes and influences the state of health. Therefore, strategies are needed that provide tailor-made approaches for specific nutritional requirements. Finally, the BMBF initiative "Action Plan for Prevention and Nutrition Research" founded, among other things, the interdisciplinary enable cluster. One of the main features of the project was the recruitment of different cohorts to develop new concepts for nutrition-related problems. For this reason, we intensively characterized these cohorts according to their nutritional behavior. Meanwhile, it is assumed that the current Covid-19 pandemic has significantly influenced their nutritional behavior. We would therefore like to invite former participants of the enable study to re-invite them to fill in questionnaires as they were used at that time. If this follow-up study reveals differences in nutritional behavior compared to the current pandemic situation, we would like to focus on micronutrient deficiencies, as it has been shown that these micronutrients may be essential for many physiological processes in the human body. Among others, they play an important role in the immune system, especially in the immune defense. With regard to Covid-19, the observation that older patients or diabetics with a vitamin D deficiency are particularly susceptible to severe disease seems interesting. Since the recording of the micronutrient status in SARS-CoV-2 infections is incomplete so far, we want to record the nutritional behavior of Covid-19 patients together with blood profiles of the micronutrients. In view of the current pandemic, this study aims to explore potential associations between dietary habits, micronutrient deficiencies (selenium, vitamin D, and zinc), and disease progression in Covid-19 patients, whether symptomatic or asymptomatic.

Health condition or problem studied

ICD10:
J06.9 - Acute upper respiratory infection, unspecified
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Covid-19 positive participants are interviewed about their dietary habits (food frequency questionnaire FFQ, 24 h food recall) and the course of the disease at two time points within three weeks. With the help of Dried Blood Spots selenium, zinc, and Vitamin D levels are determined. Former participants of the enable study will be asked to fill out FFQ and 24 h food recalls once.

Endpoints

Primary outcome:
Questionnaires will be used to determine a general nutritional score (e.g., the healthy eating index HEI) in the cohorts of the enable cluster (n= 460). This score will then be compared with the results obtained in pre-pandemic times. In addition, 200 SARS-CoV-2 positive-tested volunteers will be recruited, who will also provide information on their eating habits in order to calculate the HEI and compare between symptomatic and asymptomatic individuals.
Secondary outcome:
As a secondary goal, levels of vitamin D, selenium, and zinc from finger blood will be measured to investigate a potential association of these with symptomatic or asymptomatic progression.

Study Design

Purpose:
Prevention
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other TU München, ZIEL Institute for Food & Health, Core Facility Human Studies Freising

Recruitment period and number of participants

Planned study start date:
2020-12-03
Actual study start date:
2020-12-03
Planned study completion date:
No Entry
Actual Study Completion Date:
2021-06-16
Target Sample Size:
200
Final Sample Size:
125

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
> 18 years, positive test for SARS-CoV 2, consenting online

Exclusion Criteria

< 18 years, negative test for SARS-CoV 2

Addresses

Primary Sponsor

Address:
Technical University of Munich
Prof. Dirk Haller
Gregor-Mendel-Straße 2
85354 Freising
Germany
Telephone:
+49 8161 71 2026
Fax:
+49 8161 71 2824
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.nutrition-immunology.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Technical University of Munich (TUM)ZIEL Institute for Food and HealthCore Facility Human Studies
Prof. Thomas Skurk
Gregor-Mendel-Straße 2
85354 Freising
Germany
Telephone:
+498161712007
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Address:
Technical University of Munich (TUM)ZIEL Institute for Food and HealthCore Facility Human Studies
M.Sc. Laura Mengel
Gregor-Mendel-Straße 2
85354 Freising
Germany
Telephone:
+49 8161 71 2007
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Principal Investigator

Address:
Technical University of Munich (TUM)ZIEL Institute for Food and HealthCore Facility Human Studies
Prof. Thomas Skurk
Gregor-Mendel-Straße 2
85354 Freising
Germany
Telephone:
+498161712007
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
EIT Food iVZW
Ubicenter A Philipssite 5 box 34 Leuven
3001 Heverlee
Belgium
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://eitfood.eu

Ethics Committee

Address Ethics Committee

Address:
Ethikkommission der Fakultät für Medizin der Technischen Universität München
Ismaninger Str. 22
81675 München
Germany
Telephone:
+49-89-41404371
Fax:
+49-89-41404199
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2020-10-27
Ethics committee number:
655/20 S
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-11-30

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry