Clinical trial · Interventional
Study of the Consumption of a Food Supplement in a Group of Healthy People
Clinical Study to Evaluate the Effectiveness and Safety of the Consumption of a Food Supplement in a Group of Healthy People
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immune System and Related Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary supplementation with capsules containing rosemary and alkylglycerol | Dietary Supplement | — | UNRESOLVED |
| Dietary supplementation with control capsules | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rosemary and alkylglycerol capsules
- interventionNames
- Dietary Supplement: Dietary supplementation with capsules containing rosemary and alkylglycerol
- type
- PLACEBO_COMPARATOR
- label
- Control capsules
- interventionNames
- Dietary Supplement: Dietary supplementation with control capsules
Primary outcomes (1)
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDAl-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. PMID 15242947
- BACKGROUNDDeniau 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. PMID 20714431
- BACKGROUNDArends 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. PMID 27637832
- BACKGROUNDAugust 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. PMID 19713551
- BACKGROUNDGonzalez-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. PMID 23557932
- BACKGROUNDLivak 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. PMID 11846609