Compensation of an omega-3 deficiency
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Body mass index (BMI) = 18.5 kg/m2 - Sufficient knowledge of German to understand the study documents - Ability to present the signed informed consent form - Ability to swallow capsules
Exclusion criteria
Exclusion criteria: - Pregnancy, breastfeeding - Previous omega-3 supplementation in the last 4 months before the start of the intervention - Regular fish consumption (> 2 portions per week) - Low-fat diet (diet with reduced fat content of =30% of daily calories) - Regular intake (on average > 3 days per week) of NSAIDs (aspirin, ibuprofen) - Known history of cardiac arrhythmias, including atrial fibrillation, ventricular tachycardia or other diagnosed arrhythmias, as well as existing medical conditions or medications that could increase the risk of cardiac arrhythmias - Regular intake of antioxidant supplements (vitamin E, vitamin A, vitamin C) - Presence of a chronic disease that requires treatment and is not medically controlled, including cancer, cardiovascular disease, neurological diseases and metabolic diseases - Relevant food allergies or intolerances to algae oil - In individual cases, the study director must check whether an existing illness and/or medication intake leads to exclusion from the study - Alcohol or drug addiction - Failure to provide informed consent; unwillingness or inability to comply with the study protocol or study-related procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of the omega-3 index target range of 8-11% in >60% of subjects after 4 months of personalized algae oil supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| - Fat metabolism - Inflammatory markers - Body composition by bioimpedance analysis (BIA) - Metabolome in blood, lipidome in blood and stool, microbiome in stool, proteome in blood - Changes in cardiovascular function (ECG parameters such as PR interval and QTc times) - Feasibility of the study at the study center (adherence, capacity, ...) | — |
Countries
Germany
Contacts
Institut für Ernährungsmedizin, Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein (UKSH)