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

NCT03492086 | Completed

• 1 other identifier: IMD PI0017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune System and Related Disorders

Keywords

Rosmarinus officinalis L; alkylglycerols; immuno-nutrition; colon cancer

Outcome Measures

Primary Outcomes (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.

  Baseline and after 6 weeks of treatment

Secondary Outcomes (4)

• Changes in oxidative stress status

  Baseline and after 6 weeks

• Changes in lipid profile

  Baseline and after 6 weeks

• Gene expression analysis

  Baseline and after 6 weeks

• DNA genotyping

  Baseline

Study Arms (2)

Rosemary and alkylglycerol capsules

EXPERIMENTAL

Dietary Supplement: Dietary supplementation with capsules containing rosemary and alkylglycerol

Control capsules

PLACEBO COMPARATOR

Dietary Supplement: Dietary supplementation with control capsules

Interventions

Dietary supplementation with capsules containing rosemary and alkylglycerol DIETARY_SUPPLEMENT

Rosemary and alkylglycerol capsules

Dietary supplementation with control capsules DIETARY_SUPPLEMENT

Control capsules

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IMDEA Food: lead

Study Sites (1)

Viviana loria-Kohen

Madrid, 28049, Spain

Location

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

  PMID: 15242947 BACKGROUND

• 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.

  PMID: 20714431 BACKGROUND

• 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.

  PMID: 27637832 BACKGROUND

• 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.

  PMID: 19713551 BACKGROUND

• 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.

  PMID: 23557932 BACKGROUND

• 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.

  PMID: 11846609 BACKGROUND

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

  PMID: 11115790 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Guillermo Reglero, Proffesor

  IMDEA Food and Institute of Food Science Research (CIAL)

  STUDY DIRECTOR

• Ana Ramirez de Molina, PhD

  IMDEA Food

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 10, 2018
• Study Start: August 31, 2015
• Primary Completion: December 22, 2015
• Study Completion: December 22, 2015
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

ES (1)