Viewing Study NCT03612700



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Last Modification Date: 2024-10-26 @ 12:50 PM
Study NCT ID: NCT03612700
Status: COMPLETED
Last Update Posted: 2018-10-17
First Post: 2018-07-27

Brief Title: Presence of Cyclopropane Fatty Acids CPFA in Human Plasma
Sponsor: University of Parma
Organization: University of Parma

Study Overview

Official Title: Presence of Cyclopropane Fatty Acids CPFA in Human Plasma After CPFA-rich Diet
Status: COMPLETED
Status Verified Date: 2018-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Fatty acids containing a cyclopropane ring in their structure CPFA have been found in plants fungi a wide variety of bacteria and recently detected in dairy products and bovine meat Little is known about CPFA in mammals especially in human tissues This work aims at investigating the presence of CPFA in plasma of humans after a regular consumption of CPFA from milk and cheese A free living diet controlled in CPFA mainly deriving from Grana Padano cheese and whole milk containing CPFA will be consumed by 10 healthy normal weight volunteers for three weeks after one week of dairy products and bovine meat restricted diet Plasma of volunteers will be collected at 8 different timepoints for lipid extraction CPFA identification and quantification by GC-MS A preliminary pilot in vivo acute study involving only 1 subject will be performed for investigating the post-prandial response curve of CPFA after a portion of Grana Padano cheese
Detailed Description: Cyclopropane fatty acids CPFA as cis-910- methyleneoctadecanoic and cis- 1112- methyleneoctadecanoic acids are unusual alicyclic fatty acids which occur in plants fungi or microorganisms both Gram-negative and Gram-positive as well as protozoa and Myriapoda Some papers suggest that cyclopropane fatty acids are involved in the bacterial pathogenesis of infections and in the resistance of some bacterial strains as Lactobacillus sp Escherichia Coli Salmonella enterica Staphilococcus aureus and Pseudomonas to different environmental stresses such as temperature changes high osmolarity solvents acid pH and others as the presence of antibiotics or heavy metals in the culture medium However little is documented about the presence of CPFA in mammals Recently they were detected in milk and several dairy products in bovine meat in fish and in mushrooms Our previous results showed that the most important food sources of CPFA were dairy products mainly Grana Padano cheese and bovine meat reaching concentration of 1gkg order while food processing manufacturing seasoning steps fermentation as well as cooking did not affect CPFA content in the analyzed food matrices Furthermore CPFA intake from these foodstuffs should be considered dietary relevant in view of a possible physiological effect

Actually CPFA mainly cyclopropaneoctanoic acid 2-hexyl have been recently identified in both human serum and adipose tissue suggesting that these fatty acids are efficiently absorbed and may play a physiological role in the human body

Moreover fatty acids containing cyclopropane rings have been reported to exert biological effects on lipid metabolism kidney function inflammation and enzymes activity as cyclooxygenase and stearoyl-CoA desaturase Previous results suggested that the synthesis of CPFA in microorganisms and in plants is regulated by the expression of CPFA synthase which catalyse the addition of the methylene group from S-adenosylmethionine to double bond of the unsaturated fatty acids precursor However this enzyme has still not been identified in animals and humans To the best of our knowledge no information is present in literature about the fate of CPFA within the human body and a thorough investigation of how CPFA can be metabolised and accumulate in humans is needed

The aim of this investigation is to determine CPFA presence in human plasma after a CPFA-rich diet with controlled intake of Grana Padano cheese and whole milk containing CPFA Plasma of the volunteers will be collected at eight different timepoints for lipid extraction CPFA identification and quantification by GC-MS A preliminary pilot in vivo acute study will be performed involving only 1 subject for investigating the post-prandial response curve of CPFA after a portion of Grana Padano cheese

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None