Clinical trial NCT03492086: Study of the Consumption of a Food Supplement in a Group of Healthy People
Official title: Clinical Study to Evaluate the Effectiveness and Safety of the Consumption of a Food Supplement in a Group of Healthy People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune System and Related Disorders
Keywords: Rosmarinus officinalis L
alkylglycerols
immuno-nutrition
colon cancer
Lead sponsor: IMDEA Food
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in ex vivo cytokine profile produced by lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells (PBMCs)
timeFrame: Baseline and after 6 weeks of treatment
Secondary outcomes:
measure: Changes in oxidative stress status
timeFrame: Baseline and after 6 weeks
measure: Changes in lipid profile
timeFrame: Baseline and after 6 weeks
measure: Gene expression analysis
timeFrame: Baseline and after 6 weeks
measure: DNA genotyping
timeFrame: Baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Viviana loria-Kohen
Study officials:
affiliation: IMDEA Food and Institute of Food Science Research (CIAL)
name: Guillermo Reglero, Proffesor
role: STUDY_DIRECTOR
affiliation: IMDEA Food
name: Ana Ramirez de Molina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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. No abstract available.
citation: 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.
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. doi: 10.1006/meth.2001.1262.
citation: Suchner U, Kuhn KS, Furst P. The scientific basis of immunonutrition. Proc Nutr Soc. 2000 Nov;59(4):553-63. doi: 10.1017/s0029665100000793.