NCT03492086

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: IMDEA Food · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Immune System and Related Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary supplementation with capsules containing rosemary and alkylglycerol
DIETARY_SUPPLEMENT	Dietary supplementation with control capsules

Timeline

• Start date: 2015-08-31
• Primary completion: 2015-12-22
• Completion: 2015-12-22
• First posted: 2018-04-10
• Last updated: 2018-04-10

Locations

1 site across 1 country: Spain