Trial document




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  DRKS00022514

Trial Description

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Title

Eating habits during the Covid-19 pandemic

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Trial Acronym

MeDiCo- health Study

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URL of the Trial

https://medico-health.de/medico

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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.

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00022514
  •   2020/12/03
  •   [---]*
  •   yes
  •   Approved
  •   655/20 S, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J06.9 -  Acute upper respiratory infection, unspecified
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Interventions/Observational Groups

  •   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.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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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.

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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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2020/12/03
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

> 18 years, positive test for SARS-CoV 2, consenting online

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Exclusion Criteria

< 18 years, negative test for SARS-CoV 2

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Addresses

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    • Technical University of Munich
    • Mr.  Prof.  Dirk  Haller 
    • Gregor-Mendel-Straße 2
    • 85354  Freising
    • Germany
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    • LOEWI GmbH
    • Ms.  Dr.  Silvia  Kolossa 
    • Agnes-Pockels-Bogen 1
    • 80992  München
    • Germany
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    • Technical University of Munich (TUM)ZIEL Institute for Food and HealthCore Facility Human Studies
    • Mr.  Prof.  Thomas  Skurk 
    • Gregor-Mendel-Straße 2
    • 85354  Freising
    • Germany
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    •   +498161712007
    •   [---]*
    •   skurk at tum.de
    •   [---]*
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    • Technical University of Munich (TUM)ZIEL Institute for Food and HealthCore Facility Human Studies
    • Ms.  M.Sc.  Laura  Mengel 
    • Gregor-Mendel-Straße 2
    • 85354  Freising
    • Germany
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Sources of Monetary or Material Support

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    • EIT Food iVZW
    • Ubicenter A Philipssite 5 box 34 Leuven
    • 3001  Heverlee
    • Belgium
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.