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AzTrials

Immune System and Related DisordersFORCANCERNCT03492086

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

A study testing Dietary supplementation with capsules containing rosemary and alkylglycerol in people with Immune System and Related Disorders, run by IMDEA Food at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Immune System and Related Disorders
What is being tested?
Dietary supplementation with capsules containing rosemary and alkylglycerol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteSpain
Study dates
31 Aug 2015to 22 Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age between 18 and 55 years
  • Adequate understanding of the study.
  • Willingness to complete the entire treatment.

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Viviana loria-Kohen

    Madrid, 28049

Other trials in Spain

About this study

Official title: 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.

Being tested
Dietary supplementation with capsules containing rosemary and alkylglycerol, Dietary supplementation with control capsules
Keywords
Rosmarinus officinalis L, alkylglycerols, immuno-nutrition, colon cancer
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary supplementation with capsules containing rosemary and alkylglycerolDietary supplement

  • Dietary supplementation with control capsulesDietary supplement

Study groups in NCT03492086
Study groupRoleWhat they receive
Rosemary and alkylglycerol capsulesExperimentalNot described
Receives: Dietary Supplement: Dietary supplementation with capsules containing rosemary and alkylglycerol
Control capsulesPlacebo comparatorNot described
Receives: Dietary Supplement: Dietary supplementation with control capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 fluorescence intensity, MFI) were analyzed with the xPONENT software 4.1.

    Measured: Baseline and after 6 weeks of treatment

Secondary outcomes (4)

  1. 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).

    Measured: Baseline and after 6 weeks

  2. 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.

    Measured: Baseline and after 6 weeks

  3. 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 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)

    Measured: Baseline and after 6 weeks

  4. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2018
  2. Study start31 Aug 2015
  3. Primary completion22 Dec 2015
  4. Study completion22 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03492086
Sponsor's protocol ID
IMD PI0017
Acronym
FORCANCER
Status last verified
Apr 2018
First submitted
19 Mar 2018
Last updated
10 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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. doi: 10.1128/CDLI.11.4.720-728.2004.

    PubMed 15242947

  • Deniau AL, Mosset P, Pedrono 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.

    PubMed 20714431

  • Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach 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.

    PubMed 27637832

  • 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. No abstract available.

    PubMed 19713551

  • Gonzalez-Vallinas M, Molina S, Vicente G, de la Cueva A, Vargas T, Santoyo S, Garcia-Risco MR, Fornari T, Reglero G, Ramirez 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.

    PubMed 23557932

  • 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. doi: 10.1006/meth.2001.1262.

    PubMed 11846609

  • Suchner U, Kuhn KS, Furst P. The scientific basis of immunonutrition. Proc Nutr Soc. 2000 Nov;59(4):553-63. doi: 10.1017/s0029665100000793.

    PubMed 11115790

Questions about this trial

What is this clinical trial studying?

A study testing Dietary supplementation with capsules containing rosemary and alkylglycerol in people with Immune System and Related Disorders, run by IMDEA Food at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03492086, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.

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