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

April 2, 2018 updated by: IMDEA Food

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28049
        • Viviana loria-Kohen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosemary and alkylglycerol capsules
Dietary supplement: Dietary supplementation with capsules containing rosemary and alkylglycerol
Placebo Comparator: Control capsules
Dietary supplement: Dietary supplementation with control capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ex vivo cytokine profile produced by lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells (PBMCs)
Time Frame: Baseline and after 6 weeks of treatment
Isolated PBMCs were first incubated for 12h, and then after LPS treated. Supernatants were recovered to determine concentrations of Interleukin (IL) -1B, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IFNy and TNFa using a magnetic bead-based immunoassay (Human High Sensitivity T Cell Magnetic Bead Panel A MAGPIX-Luminex) kit from Millipore, following the manufacturer's instructions. A minimum of 50 beads per parameter was analyzed by the MAGPIX-Luminex system. Raw data (median fluorescence intensity, MFI) were analyzed with the xPONENT software 4.1.
Baseline and after 6 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in oxidative stress status
Time Frame: Baseline and after 6 weeks

To evaluate the changes in the oxidative stress the following biomarkers were measured in urine samples:

  • Oxidized-low density lipoproteins measured by sandwich enzyme-linked immunosorbent assay (ELISA) by using the monoclonal antibody mAb-4E6 (Mercodia AB, Sweden)
  • Isoprostanes and thromboxane B2 quantified by competitive ELISA (Enzo Biochem, Inc., NY, USA and Oxford Biomedical Research, MI, USA, respectively).
Baseline and after 6 weeks
Changes in lipid profile
Time Frame: Baseline and after 6 weeks
To evaluate lipid improvements the following measurements were considered: Triacylglycerol, Total Cholesterol, low Density Lipoprotein and High-Density Lipoprotein measured by routine laboratory (CQS, Madrid, Spain, which follows the UNE-ISO 15189:2007 directives) methods.
Baseline and after 6 weeks
Gene expression analysis
Time Frame: Baseline and after 6 weeks
Gene-expression assays were performed in a HT-7900 Fast Real time PCR. GAPDH was used as endogenous control. RT-StatMiner software (Integromics® Inc., Madison, USA) was used to detect and determine the quality control and differential expression analyses. The Expression Suite Software (Life Technologies) program was used to obtain the Ct data. The ΔCt (Ct gene-CtGAPDH) was calculated and then the relative expression (RQ) between visits was calculated (V3-V1) following the 2-ΔΔCt method (Livak and Schmittgen 2001)
Baseline and after 6 weeks
DNA genotyping
Time Frame: Baseline
Genotyping was performed using the QuantStudio 12 K Flex Real-Time PCR System (Life Technologies Inc., Carlsbad, CA) with a TaqMan OpenArray plates. Single nucleotide polymorphisms (SNPs) involved in different parts of the pathogenic processes of inflammation, immune system, obesity, lipid metabolism, redox homeostasis and cancer, were analyzed using TaqMan Genotyper software.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IMDEA Food

Investigators

  • Study Director: Guillermo Reglero, Proffesor, IMDEA Food and Institute of Food Science Research (CIAL)
  • Principal Investigator: Ana Ramirez de Molina, PhD, IMDEA Food

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2015

Primary Completion (Actual)

December 22, 2015

Study Completion (Actual)

December 22, 2015

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IMD PI0017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Immune System and Related Disorders

Clinical Trials on Dietary supplementation with capsules containing rosemary and alkylglycerol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe