The Good Health Retrospective Data Analysis

ISRCTN	ISRCTN12444421
DOI	https://doi.org/10.1186/ISRCTN12444421
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	P6210-045-011
Sponsor	BIOGENA GmbH & Co KG
Funder	BIOGENA GmbH & Co KG

Submission date: 25/06/2025
Registration date: 21/07/2025
Last edited: 23/07/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Health is a complex area of research involving various areas and the network of interactions between physical, mental, and social well-being domains. Micronutrient status appears to be closely tied to health. Every 4 to 5 years, Austrian nutrition reports publish an assessment of the nutritional status of the population, which also analyzes the supply of essential micronutrients. These reports generally form a basis in the food and nutrition sector, not only on a national level, but also on a European and international level. Continuous publication of the nutrition reports in Austria ensures regular monitoring and access to the nutritional status of the population. However, the initial situation of the individual respondent, including personal metabolism, cannot be taken into account when making mathematical conclusions about the supply status, as the previous nutritional reports have done thus far. For example, using food tables, random error ranges from 2 to 20 % for individual estimates of iron and calcium have been reported. Additionally, food estimations based on frequency reports involve errors up to 90 %, and are typically in the 20-50 % range. Therefore, this study aims to retrospectively analyze the micronutrient status of a large sample of healthy Austrian adults, and to identify possible differences in the micronutrient status based on various factors, solely based on retrospective data analyses in 2025 of an already existing data set.

Who can participate?
Adults 20 to 65 years of age and residing in Austria. Participants are enrolled on a voluntary basis via direct contact with registered physicians in primary care offices. The region for involvement is Austria, nationwide and voluntary in all cases.

What does the study involve?
Analysis of sociodemographic-anthropometric variables: region of residence in Austria, sex, age, body weight, calculated body mass index (BMI), including a questionnaire with self-reported measures for diet pattern; physical activity levels; alcohol and nicotine consumption; supplement intake; medication intake (based on sex, age, substance prevalence); and a blood sample.

What are the possible benefits and risks of participating?
As this is a retrospective study, there is no direct involvement or risk for the patients.

Where is the study run from?
University of Innsbruck (Austria)

When is the study starting and how long is it expected to run for?
The study began in March 2023 and will end in December 2025.

Who is funding the study?
BIOGENA GmbH & Co KG (Austria)

Who is the main contact?
Prof. Dr. rer. nat. Katharina Wirnitzer, katharina.wirnitzer@uibk.ac.at

Contact information

Prof Katharina Wirnitzer
Public, Scientific, Principal investigator

Fürstenweg 185
Innsbruck
6020
Austria

Phone	+43 (512)507-0
Email	katharina.wirnitzer@uibk.ac.at

Study information

Primary study design	Observational
Study design	Retrospective data analysis
Secondary study design	Cross sectional study
Study type	Participant information sheet
Scientific title	Retrospective data analysis of the micronutrient status of healthy adults in Austria and the relationship with health variables
Study acronym	GHRDA
Study objectives	This research hypothesized that there are distinct associations between blood micronutrient levels and health indicators in adulthood, including blood lipids and body composition.
Ethics approval(s)	Ethics approval not required
Ethics approval additional information	Due to the retrospective design, no ethics approval is applicable for the present project. The new medical methods involve treatments after existing conventional medical treatment methods have been exhausted (Section 30 of the Salzburg Hospitals Act). This situation, in combination with the lack of intervention, blood sampling via registered doctors as standardized medical check-up, anonymization of the data and the fact that no ethics vote would have been legally required for an Austrian project with a similar structure - the Austrian Nutrition Report 2012 - and that this was obtained purely on a voluntary basis, leads to the conclusion that no ethics vote was required for the aforementioned research project.
Health condition(s) or problem(s) studied	Micronutrient status of healthy adults in Austria and the relationship with health variables
Intervention	This project is retrospective, includes no intervention, and utilizes data from an online questionnaire on sociodemographic characteristics as well as a previous blood collection for micronutrient laboratory analysis. Sociodemographic-anthropometric variables: region of residence in Austria, sex, age, body weight, calculated body mass index (BMI), including a questionnaire with self-reported measures for diet pattern, physical activity levels, alcohol and nicotine consumption, supplement intake, and medication intake (based on sex, age, substance prevalence). Blood sample: omega-3-index, cholesterol corrected coenzyme q10, folic acid, ferritin, vitamin B12, vitamin D, vitamin B6, molybdenum, manganese, selenium, zinc, copper, magnesium, calcium, potassium, iron, soluble transferrin-receptor, hemoglobin, wrCRP, apolipoprotein A, triglycerides, HDL-C, LDL-C, total cholesterol, homocysteine, leukocytes, erythrocytes, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, thrombocytes, and mean platelet volume.
Intervention type	Other
Primary outcome measure(s)	1. Body weight (kg) reported by questionnaire, single cross-sectional assessment 2. Body mass index (BMI; kg/m2) calculated from questionnaire, single cross-sectional assessment 3. Region of residence in Austria reported by questionnaire, single cross-sectional assessment 4. Omega-3-index measured by blood test (% of total Fatty Acids), single cross-sectional assessment 5. Cholesterol measured by blood test (mg/dl), single cross-sectional assessment 6. Adjusted coenzyme q10 (μmol/mmol Chol) measured by blood test, single cross-sectional assessment 7. Folic acid measured by blood test (ng/ml), single cross-sectional assessment 8. Ferritin measured by blood test (ng/ml), single cross-sectional assessment 9. Vitamin B 12 measured by blood test (pg/ml), single cross-sectional assessment 10. Vitamin D measured by blood test (nmol/l), single cross-sectional assessment 11. Vitamin B 6 measured by blood test (μg/l), single cross-sectional assessment 12. Molybdenum measured by blood test (μ/l), single cross-sectional assessment 13. Manganese measured by blood test (μ/l), single cross-sectional assessment 14. Selenium measured by blood test (μ/l), single cross-sectional assessment 15. Zinc measured by blood test (mg/l), single cross-sectional assessment 16. Copper measured by blood test (mg/l), single cross-sectional assessment 17. Magnesium measured by blood test (mg/l), single cross-sectional assessment 18. Calcium measured by blood test (mg/l), single cross-sectional assessment 19. Potassium measured by blood test (mg/l), single cross-sectional assessment 20. Iron measured by blood test (mg/l), single cross-sectional assessment 21. Soluble transferrin-receptor measured by blood test (mg/l), single cross-sectional assessment 22. Hemoglobin measured by blood test (g/dl), single cross-sectional assessment 23. wrCRP measured by blood test (mg/l), single cross-sectional assessment 24. Apolipoprotein A measured by blood test (g/l), single cross-sectional assessment 25. Triglycerides measured by blood test (mg/dl), single cross-sectional assessment 26. HDL-C measured by blood test (mg/dl), single cross-sectional assessment 27. LDL-C measured by blood test (mg/dl), single cross-sectional assessment 28. Homocysteine measured by blood test (μmol/l), single cross-sectional assessment 29. Leukocytes measured by blood test (cells/nl), single cross-sectional assessment 30. Erythrocytes measured by blood test (cells/pl), single cross-sectional assessment 31. Hematocrit measured by blood test (V%), single cross-sectional assessment 32. Mean corpuscular volume measured by blood test (fl), single cross-sectional assessment 33. Mean corpuscular hemoglobin measured by blood test (pg), single cross-sectional assessment 34. Mean corpuscular hemoglobin concentration measured by blood test (g/dl Ery), single cross-sectional assessment 35. Thrombocytes measured by blood test (cells/nl), single cross-sectional assessment 36. Mean platelet volume measured by blood test (fl), single cross-sectional assessment
Key secondary outcome measure(s)	1. Physical activity levels reported by questionnaire (WHO PA guidelines 150-300 min/week), single cross-sectional assessment 2. Dietary pattern reported by questionnaire, single cross-sectional assessment 3. Diastolic blood pressure assessed during medical check-up examination (mmHg), single cross-sectional assessment 4. Alcohol consumption reported by questionnaire, single cross-sectional assessment 5. Smoking prevalence reported by questionnaire, single cross-sectional assessment 6. Supplement intake reported by questionnaire, single cross-sectional assessment 7. Medication intake reported by questionnaire, single cross-sectional assessment
Completion date	31/12/2025

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	20 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	488
Total final enrolment	1377
Key inclusion criteria	1. Reside in Austria 2. Aged at least 20 years 3. No severe health ailments
Key exclusion criteria	1. Failing to provide written informed consent 2. Being younger than 20 years or older than 65 years 3. Lactating or pregnant 4. Being diagnosed with a severe health condition (such as diabetes, cardiovascular disease, hypertension, specific allergies, chronic lung disease, liver disease, musculoskeletal disorders, cancer, mental illness, chronic pain, or COVID-19) 5. Taking medications for severe illnesses (whether prescribed or self-administered) 6. Incomplete questionnaires or lacking responses to key questions
Date of first enrolment	25/03/2021
Date of final enrolment	27/04/2021

Locations

Countries of recruitment

Austria

Study participating centre

University of Innsbruck

Fürstenweg 185
Innsbruck
6020
Austria

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	Data will be used and analyzed exclusively and only in the context of the study. The datasets generated and/or analyzed during the current study are not expected to be made available due to data security laws and protection.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/07/2025: Internal review.
25/06/2025: Study's existence confirmed by BIOGENA GmbH & Co KG.