Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04232852 |
Other study ID # |
???427/12-06-2019 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 12, 2019 |
Est. completion date |
January 26, 2021 |
Study information
Verified date |
March 2022 |
Source |
Attikon Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Metabolic Syndrome (MetS) and cardiovascular disease are associated with systemic
inflammation (SI). Activation of the mechanisms of inflammation is triggered by the
inflammatory cytokines. Τhe NLRP3 inflammasome is activated by microbial-derived low
molecular weight (LMW) factors, short chain fatty acids (SCFAs), pathogen-associated
molecular pattern molecules (PAMPs), damage-associated molecular pattern molecules (DAMPs),
and monosodium urate crystals. Probiotics can regulate inflammation in two ways: 1)
indirectly, by producing SCFAs as well as increasing synthesis of antimicrobial peptides and
2) directly, by binding innate immune system receptors Toll-like (TLR 2, 4, 9) and triggering
important signaling pathways associated with activation of NLRs affecting the formation of
inflammasome, thus the inflammatory response.
Description:
Metabolic Syndrome (MetS) is associated with low-grade systemic inflammation (SI). Activation
of the mechanisms of inflammation is triggered by the inflammatory cytokines produced in the
adipose tissue. Among them, IL-1β interleukin plays a central role in cardiovascular disease.
The active form of IL-1β results by the conversion of its inactive precursor after an
infectious/inflammatory stimulus. The Nucleotide-binding Oligomerization Domain (NOD)-like
Receptor containing Pyrin domain 3 (NLRP3 or cryopyrin) inflammasome is a multiprotein
complex that activates caspase 1, leading to the processing and secretion of the
pro-inflammatory cytokines interleukin-1β (IL-1β) via the NLRP3/caspase pathway. Τhe NLRP3
inflammasome is activated by microbial-derived Low Molecular Weight (LMW) factors, short
chain fatty acids (SCFAs), Pathogen-associated molecular pattern molecules (PAMPs),
Damage-associated molecular pattern molecules (DAMPs), and monosodium urate crystals.
It is a randomized, double-blind clinical trial in patients with MetS and cardiovascular
disease. Patients will be randomized into two groups: A. those who will receive probiotic
supplements and B. placebo-treated patients. Both groups will follow the usual clinical
practice as far as drugs and diet concerned.
Τhe primary objective of this study is to investigate the effect of administration of the
probiotic mix on IL-1β production by stimulated peripheral blood mononuclear cells (PBMCs) in
patients at high cardiovascular risk with MetS at the end of the intervention. Secondly, to
investigate the effect of probiotics on endothelial glycocalyx thickness, on hrCRP and on
HbA1c levels, on the components of the MetS, on the gut microbiota at the end and 4 weeks
after the completion of the intervention.
Time frame 12 weeks.