2.1. Study Design (Screening)
weight gain, infections, period).Weight loss
FOOD ALLERGIES, INFECTIONS, CHRONIC DISEASES
The KoALA study was conducted as a randomized, single-center intervention study in parallel design (four arms: defined consumption of linseed oil; differing background diets for three groups using prepared menu plans; one control group; the figure in In early 2018, participants were recruited using flyers and press releases. The flyers were distributed in public facilities, medical practices, and pharmacies in Jena.The following inclusion criteria were applied:Women (in menopause) and men (50% each), aged between 40 and 65 years, body mass index (BMI) < 30 kg/mModerately elevated low-density lipoprotein (LDL) cholesterol (>3 mmol/L).Consumption of a traditional “Western diet” composed of meat, sausage, dairy products, cereals, vegetables, fruits, etc.Stable eating habits at least one year before enrollment.No antihypertensive medication or stable dose for >3 months prior to the start of the study and during the entire study period.The following exclusion criteria were applied:Acute or chronic diseases which could affect the results of the present study.Use of medication, including systemic glucocorticoids or lipid-lowering medication.Use of dietary supplements, incl. multivitamins, fish oil capsules, minerals and trace elements (three months before and during the entire study period).Weight loss or weight gain (>3 kg) during the last three months before the study began.Relevant food allergies (e.g., milk, nuts).Pregnancy or lactation.Adherence of the subjects to the dietary habits as defined (Western diet, stable eating habits before enrollment, renunciation of dietary supplements) was verified by a personal interview and a questionnaire.Before the preliminary phase, 200 subjects were screened for enrollment and 134 participants met the inclusion criteria (Following the informed consent and after confirmation of the inclusion and exclusion criteria, participants were scheduled for the baseline assessment.Participants could be withdrawn from the study at any time after enrollment for the following reasons: at the patient’s request, due to severe infections, or if patient compliance with the study protocol was in doubt. The study was conducted in accordance to the Helsinki Declaration of 1975, as revised in 1983. The study protocol was approved by the Ethical Committee of the Friedrich Schiller University Jena (protocol code 5419-01/18) and registered by ClinicalTrails.gov (NCT03558776).