Study of the Consumption of a Food Supplement in a Group of Healthy People

Clinical Study to Evaluate the Effectiveness and Safety of the Consumption of a Food Supplement in a Group of Healthy People

Bioactive supplements might display relevant therapeutic properties according to validated molecular effects. Herein, the effect of a supplement based on diterpenes from Rosmarinus Officinalis L. and alkylglycerols with proven properties against signaling pathways involved in tumorigenesis is evaluated. The biological and molecular effects of this supplement, mainly based on expected effects on immune and genetic modulatory properties is investigated. For this purpose, 60 healthy volunteers were enrolled in a six week, double-blind, randomized and parallel pilot study with two study arms -rosemary and alkylglycerol containing capsules and control capsules. The study includes the analysis of (1) immunological parameters (ex vivo cytokine profile of LPS stimulated PBMC and PBMC phenotyping by cluster differentiation (CD) markers), (2) regulation of the expression of genes linked to immuno-modulation, inflammation, oxidative stress response and cancer, and (3) the analysis of correlation of selected genetic variants (SNPs) with the differential responses among individuals.

Inclusion Criteria:

• Age between 18 and 55 years
• Adequate understanding of the study.
• Willingness to complete the entire treatment.

Exclusion Criteria:

• BMI >30
• Diagnosis of type 2 diabetes mellitus (T2D), hypertension, dyslipidemia or other cardiometabolic disorders
• Impaired cognitive function;
• Diagnosed hepatic, renal, or cardiovascular disease
• Subjects with primary immunodeficiency disorders, consumption of drugs with influence on the immune system, splenectomy.
• Presence of other pathologies like asthma, food allergies, Crohn's, myasthenia gravis, lupus
• Consumption of vitamins, minerals, supplements of antioxidant extracts or protein supplements in the 2 weeks prior to the start of the study
• Subjects treated with drugs affecting the lipid or glycemic profile during the previous 30 days
• Consumption of anticoagulants or antiplatelet agents, cyclosporine, acetylsalicylic acid, antihistamines or sedatives
• Hypersensitivity to rosemary, to its components or other members of the family of lipped plants or to soybean as excipient of the capsules
• Allergy or hypersensitivity to fish
• Habitual smoking or high consumption alcohol
• Pregnant or lactating women
• High-intensity physical exercise.