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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-12-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Immune System and Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rosemary and alkylglycerol capsules

Group Type EXPERIMENTAL

Dietary supplementation with capsules containing rosemary and alkylglycerol

Intervention Type DIETARY_SUPPLEMENT

Control capsules

Group Type PLACEBO_COMPARATOR

Dietary supplementation with control capsules

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Dietary supplementation with capsules containing rosemary and alkylglycerol

Intervention Type DIETARY_SUPPLEMENT

Dietary supplementation with control capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes