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

Immune System and Related Disorders Clinical Trial

— FORCANCER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492086
• Other study ID #: IMD PI0017
• Status: Completed
• Phase: N/A
• First received: March 19, 2018
• Last updated: April 2, 2018
• Start date: August 31, 2015
• Est. completion date: December 22, 2015

Study information

• Verified date: April 2018
• Source: IMDEA Food
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 22, 2015
• Est. primary completion date: December 22, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune System and Related Disorders

Intervention

Dietary Supplement:
• Dietary supplementation with capsules containing rosemary and alkylglycerol

• Dietary supplementation with control capsules

Locations

Country	Name	City	State
Spain	Viviana loria-Kohen	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IMDEA Food

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Al-Darmaki S, Knightshead K, Ishihara Y, Best A, Schenkein HA, Tew JG, Barbour SE. Delineation of the role of platelet-activating factor in the immunoglobulin G2 antibody response. Clin Diagn Lab Immunol. 2004 Jul;11(4):720-8. — View Citation

Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hütterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Mühlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6. — View Citation

August DA, Huhmann MB; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. clinical guidelines: nutrition support therapy during adult anticancer treatment and in hematopoietic cell transplantation. JPEN J Parenter Enteral Nutr. 2009 Sep-Oct;33(5):472-500. doi: 10.1177/0148607109341804. — View Citation

Deniau AL, Mosset P, Pédrono F, Mitre R, Le Bot D, Legrand AB. Multiple beneficial health effects of natural alkylglycerols from shark liver oil. Mar Drugs. 2010 Jul 19;8(7):2175-84. doi: 10.3390/md8072175. Review. — View Citation

González-Vallinas M, Molina S, Vicente G, de la Cueva A, Vargas T, Santoyo S, García-Risco MR, Fornari T, Reglero G, Ramírez de Molina A. Antitumor effect of 5-fluorouracil is enhanced by rosemary extract in both drug sensitive and resistant colon cancer cells. Pharmacol Res. 2013 Jun;72:61-8. doi: 10.1016/j.phrs.2013.03.010. Epub 2013 Apr 1. — View Citation

Livak KJ, Schmittgen TD. Analysis of relative gene expression data using real-time quantitative PCR and the 2(-Delta Delta C(T)) Method. Methods. 2001 Dec;25(4):402-8. — View Citation

Suchner U, Kuhn KS, Fürst P. The scientific basis of immunonutrition. Proc Nutr Soc. 2000 Nov;59(4):553-63. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in ex vivo cytokine profile produced by lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells (PBMCs)	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 ?uorescence intensity, MFI) were analyzed with the xPONENT software 4.1.	Baseline and after 6 weeks of treatment
Secondary	Changes in oxidative stress status	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
Secondary	Changes in lipid profile	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
Secondary	Gene expression analysis	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 ?Ct (Ct gene-CtGAPDH) was calculated and then the relative expression (RQ) between visits was calculated (V3-V1) following the 2-??Ct method (Livak and Schmittgen 2001)	Baseline and after 6 weeks
Secondary	DNA genotyping	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