Presence of Cyclopropane Fatty Acids (CPFA) in Human Plasma

October 12, 2018 updated by: Daniele Del Rio, University of Parma

Presence of Cyclopropane Fatty Acids (CPFA) in Human Plasma After CPFA-rich Diet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cyclopropane fatty acids (CPFA), as cis-9,10- methyleneoctadecanoic and cis- 11,12- 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 1g/kg 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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43125
        • Department of Food and Drugs, University of Parma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- BMI 19-29 (kg/m2)

Exclusion Criteria:

  • pregnancy and lactation
  • gastrointestinal disorders
  • metabolic diseases
  • drugs and food supplements interfering with lipid metabolism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPFA-rich diet
Free living diet controlled in CPFA intake
Other: CPFA-rich foods
Daily consumption of Grana Padano cheese (50 g) and whole milk (250 mL) for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPFA plasmatic concentration
Time Frame: Fasting CPFA plasma concentration [time -7 days, time 0 (after 1 week of CPFA restricted diet), time 3, 6, 9, 12, 15, 18 days]
Fasting concentration of CPFA
Fasting CPFA plasma concentration [time -7 days, time 0 (after 1 week of CPFA restricted diet), time 3, 6, 9, 12, 15, 18 days]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Parma

Investigators

  • Principal Investigator: Daniele Del Rio, Professor, Department of Food and Drugs
  • Principal Investigator: Augusta Caligiani, Professor, Department of Food and Drugs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Actual)

September 28, 2018

Study Completion (Actual)

September 28, 2018

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DDR-CPFA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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