Representative sampling of the German population
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Women and men aged between 18 and 80 years of age who live in private households in the Federal Republic of Germany, are registered as having their main residence at one of the 120 research sites (sample points), and were randomly selected to take part in the study via local registration offices - Individuals who have sufficient knowledge of the German language to be able to take part in the interviews - Individuals who have given their voluntary and written consent to participate in the study
Exclusion criteria
Exclusion criteria: General exclusion criteria - Individuals who have not provided written consent to participate in the study - Individuals who do not have sufficient knowledge of the German language or who are cognitively unable to take part in the interviews - Individuals residing in residential care facilities (e.g. nursing homes, specialised residential care settings) - Individuals whose liberty has been restricted by a court or administrative order - Individuals for whom a legal guardian has been appointed with the power to withhold consent in health-related matters Exclusion criteria during the study (drop-out) Participants will be excluded from the study after inclusion if any of the following criteria apply: - Withdrawal of consent to participate in the study - Occurrence of significant deviations from the study protocol (e.g. failure to attend interview/examination appointments) - Occurrence of unacceptable, adverse events Exclusion criteria for certain examinations Participants will be excluded from certain examinations if specific criteria apply, which must be assessed prior to the examination in accordance with the established Standard Operating Procedure (SOP): - Anthropometry: e.g. restrictions preventing brief periods of standing - Blood sampling: e.g. infectious skin conditions, lymphoedema, nerve damage, confirmed haemophilia A and B Non-participation in the described examination components does not result in exclusion from the study. Exclusion criteria for subsequent analysis Participants will not be included in further data analysis if any of the following criteria apply: - Occurrence of significant deviations from the study protocol (e.g. failure to attend interview/examination appointments) - Absence of relevant data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following main objectives have been set for the initial study: - To characterise food consumption and energy/nutrient intake (including dietary supplements) among the adult population living in Germany - To compare and evaluate food consumption and energy/nutrient intake with recommended levels (e.g. based on the dietary recommendations of the German Nutrition Society (DGE)) - Characterisation of the nutrient status of the adult population living in Germany for selected, potentially critical nutrients, using biological samples (blood/urine) - Assessment of the nutrient status using actual-target comparisons (e.g. based on internationally recognised reference values for nutrient status) | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, the following secondary objectives have been defined for the initial study: - Characterisation of study participants in terms of sociodemographics, age, sex, body mass index, waist circumference, nutritional situation, physical activity (questionnaire) and other lifestyle factors (e.g. smoking, alcohol consumption) - Determination of the prevalence of overweight and obesity - Collection of health data by a brief medical history - Analysis of the relationships between nutrient status and characteristics such as sex, age, anthropometric parameters, lifestyle factors, medication use and nutrient intake - Analysis of the relationships between food consumption and characteristics such as sex, age, socioeconomic status, body weight and lifestyle factors - Applicability of minimally invasive blood sampling methods (microsampling) for determining the status of selected nutrients, and a comparative assessment of the status of selected nutrients (e.g. vitamin D, vitamin B12, selenium) in venous and capillary blood - Investigation of the metabolome in biological samples (blood/urine) - Assessment and evaluation of study participants’ satisfaction, particularly with regard to home visits The following secondary objectives have been defined as part of the collaboration with the German Federal Institute for Riskmanagement (BfR): - Investigation of toxicologically relevant parameters (e.g. mycotoxins, dioxins/polychlorinated biphenyls (PCBs), PFAS, melamine, (semi-)metals: heavy metals (Al, As, Pb, Cd, Ni, Hg) and minerals (Mg, Zn, Cr, Cu, Mn, Mo)) in biological samples (blood/urine) | — |
Countries
Germany
Contacts
Max Rubner-Institut