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

NCT03492086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-04-10

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Dietary supplementation with capsules containing rosemary and alkylglycerol

DIETARY_SUPPLEMENT

Dietary supplementation with control capsules

Sponsors & Collaborators

  • IMDEA Food

    lead OTHER

Principal Investigators

  • Guillermo Reglero, Proffesor · IMDEA Food and Institute of Food Science Research (CIAL)

  • Ana Ramirez de Molina, PhD · IMDEA Food

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-12-22
Completion
2015-12-22

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03492086 on ClinicalTrials.gov