Study of the Consumption of a Food Supplement in a Group of Healthy People (FORCANCER)

IMDEA Food

Status

Completed

Conditions

Immune System and Related Disorders

Treatments

Dietary Supplement: Dietary supplementation with capsules containing rosemary and alkylglycerol

Dietary Supplement: Dietary supplementation with control capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT03492086

IMD PI0017

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.