Biological AvailabilityNCT03612700
Presence of Cyclopropane Fatty Acids (CPFA) in Human Plasma
A study testing CPFA-rich foods in people with Biological Availability, run by University of Parma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- CPFA-rich foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 6 Aug 2018to 28 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 19-29 (kg/m2)
Who cannot join
- pregnancy and lactation
- gastrointestinal disorders
- metabolic diseases
- drugs and food supplements interfering with lipid metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Biological Availability
- Being tested
- CPFA-rich foods
- Keywords
- Cyclopropane fatty acids, GC-MS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPFA-rich foodsOther
Daily consumption of Grana Padano cheese (50 g) and whole milk (250 mL) for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CPFA-rich diet | Experimental | Free living diet controlled in CPFA intake Receives: Other: CPFA-rich foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPFA plasmatic concentration
Fasting concentration of CPFA
Measured: Fasting CPFA plasma concentration [time -7 days, time 0 (after 1 week of CPFA restricted diet), time 3, 6, 9, 12, 15, 18 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start6 Aug 2018
- Primary completion28 Sep 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Biological AvailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Del Rio, University of Parma
- Investigators
- Daniele Del Rio, Professor, Principal investigator, Department of Food and DrugsAugusta Caligiani, Professor, Principal investigator, Department of Food and Drugs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612700
- Sponsor's protocol ID
- DDR-CPFA
- Status last verified
- Oct 2018
- First submitted
- 27 Jul 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore BS, Floss HG. Biosynthesis of Cyclic Fatty Acids Containing Cyclopropyl-, Cyclopentyl-, Cyclohexyl-, and Cycloheptyl-rings. Reference Module in Chemistry, Molecular Sciences, and Chemical Engineering, from Comprehensive Natural Products Chemistry 1:61-82, 1999
Montanari C, Sado Kamdem SL, Serrazanetti DI, Etoa FX, Guerzoni ME. Synthesis of cyclopropane fatty acids in Lactobacillus helveticus and Lactobacillus sanfranciscensis and their cellular fatty acids changes following short term acid and cold stresses. Food Microbiol. 2010 Jun;27(4):493-502. doi: 10.1016/j.fm.2009.12.003. Epub 2010 Jan 6.
PubMed 20417398Poger D, Mark AE. A ring to rule them all: the effect of cyclopropane Fatty acids on the fluidity of lipid bilayers. J Phys Chem B. 2015 Apr 30;119(17):5487-95. doi: 10.1021/acs.jpcb.5b00958. Epub 2015 Apr 16.
PubMed 25804677Marseglia A, Caligiani A, Comino L, Righi F, Quarantelli A, Palla G. Cyclopropyl and omega-cyclohexyl fatty acids as quality markers of cow milk and cheese. Food Chem. 2013 Oct 15;140(4):711-6. doi: 10.1016/j.foodchem.2013.01.029. Epub 2013 Jan 23.
PubMed 23692757Caligiani A, Marseglia A, Palla G. An overview on the presence of cyclopropane fatty acids in milk and dairy products. J Agric Food Chem. 2014 Aug 6;62(31):7828-32. doi: 10.1021/jf4057204. Epub 2014 Jul 24.
PubMed 25033416Sledzinski T, Mika A, Stepnowski P, Proczko-Markuszewska M, Kaska L, Stefaniak T, Swierczynski J. Identification of cyclopropaneoctanoic acid 2-hexyl in human adipose tissue and serum. Lipids. 2013 Aug;48(8):839-48. doi: 10.1007/s11745-013-3806-2. Epub 2013 Jun 11.
PubMed 23754307Bichi E, Toral PG, Hervas G, Frutos P, Gomez-Cortes P, Juarez M, de la Fuente MA. Inhibition of ∆9-desaturase activity with sterculic acid: effect on the endogenous synthesis of cis-9 18:1 and cis-9, trans-11 18:2 in dairy sheep. J Dairy Sci. 2012 Sep;95(9):5242-5252. doi: 10.3168/jds.2012-5349.
PubMed 22916929Jones SE, Whitehead K, Saulnier D, Thomas CM, Versalovic J, Britton RA. Cyclopropane fatty acid synthase mutants of probiotic human-derived Lactobacillus reuteri are defective in TNF inhibition. Gut Microbes. 2011 Mar-Apr;2(2):69-79. doi: 10.4161/gmic.2.2.15282. Epub 2011 Mar 1.
PubMed 21637024Kadegowda AK, Burns TA, Pratt SL, Duckett SK. Inhibition of stearoyl-CoA desaturase 1 reduces lipogenesis in primary bovine adipocytes. Lipids. 2013 Oct;48(10):967-76. doi: 10.1007/s11745-013-3823-1. Epub 2013 Aug 9.
PubMed 23929455Mika A, Stepnowski P, Chmielewski M, Malgorzewicz S, Kaska L, Proczko M, Ratnicki-Sklucki K, Sledzinski M, Sledzinski T. Increased Serum Level of Cyclopropaneoctanoic Acid 2-Hexyl in Patients with Hypertriglyceridemia-Related Disorders. Lipids. 2016 Jul;51(7):867-73. doi: 10.1007/s11745-016-4141-1. Epub 2016 Mar 22.
PubMed 27003900Schneider AC, Beguin P, Bourez S, Perfield JW 2nd, Mignolet E, Debier C, Schneider YJ, Larondelle Y. Conversion of t11t13 CLA into c9t11 CLA in Caco-2 cells and inhibition by sterculic oil. PLoS One. 2012;7(3):e32824. doi: 10.1371/journal.pone.0032824. Epub 2012 Mar 12.
PubMed 22427892Grogan DW, Cronan JE Jr. Cyclopropane ring formation in membrane lipids of bacteria. Microbiol Mol Biol Rev. 1997 Dec;61(4):429-41. doi: 10.1128/mmbr.61.4.429-441.1997.
PubMed 9409147WOOD R, REISER R. CYCLOPROPANE FATTY ACID METABOLISM: PHYSICAL AND CHEMICAL IDENTIFICATION OF PROPANE RING METABOLIC PRODUCTS IN THE ADIPOSE TISSUE. J Am Oil Chem Soc. 1965 Apr;42:315-20. doi: 10.1007/BF02540137. No abstract available.
PubMed 14279117Wessjohann LA, Brandt W, Thiemann T. Biosynthesis and metabolism of cyclopropane rings in natural compounds. Chem Rev. 2003 Apr;103(4):1625-48. doi: 10.1021/cr0100188. No abstract available.
PubMed 12683792Kim BH, Kim S, Kim HG, Lee J, Lee IS, Park YK. The formation of cyclopropane fatty acids in Salmonella enterica serovar Typhimurium. Microbiology (Reading). 2005 Jan;151(Pt 1):209-218. doi: 10.1099/mic.0.27265-0.
PubMed 15632439
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Cyclopropane Fatty Acids (CPFA) in Human Plasma After CPFA-rich Diet
- ClinicalTrials.gov ID
- NCT03612700
- Acronym / sponsor ID
- DDR-CPFA
- Conditions
- Biological Availability
- Keywords
- Cyclopropane fatty acids, GC-MS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPFA-rich diet | Experimental | Other: CPFA-rich foodsFree living diet controlled in CPFA intake |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 19-29 (kg/m2)
Key exclusion criteria (4 listed)
- pregnancy and lactation
- gastrointestinal disorders
- metabolic diseases
- drugs and food supplements interfering with lipid metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPFA-rich foodsDaily consumption of Grana Padano cheese (50 g) and whole milk (250 mL) for 3 weeks. | Other | CPFA-rich diet |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- BackgroundMoore BS, Floss HG. Biosynthesis of Cyclic Fatty Acids Containing Cyclopropyl-, Cyclopentyl-, Cyclohexyl-, and Cycloheptyl-rings. Reference Module in Chemistry, Molecular Sciences, and Chemical Engineering, from Comprehensive Natural Products Chemistry 1:61-82, 1999
- Background: PubMed 20417398Montanari C, Sado Kamdem SL, Serrazanetti DI, Etoa FX, Guerzoni ME. Synthesis of cyclopropane fatty acids in Lactobacillus helveticus and Lactobacillus sanfranciscensis and their cellular fatty acids changes following short term acid and cold stresses. Food Microbiol. 2010 Jun;27(4):493-502. doi: 10.1016/j.fm.2009.12.003. Epub 2010 Jan 6.
- Background: PubMed 25804677Poger D, Mark AE. A ring to rule them all: the effect of cyclopropane Fatty acids on the fluidity of lipid bilayers. J Phys Chem B. 2015 Apr 30;119(17):5487-95. doi: 10.1021/acs.jpcb.5b00958. Epub 2015 Apr 16.
- Background: PubMed 23692757Marseglia A, Caligiani A, Comino L, Righi F, Quarantelli A, Palla G. Cyclopropyl and omega-cyclohexyl fatty acids as quality markers of cow milk and cheese. Food Chem. 2013 Oct 15;140(4):711-6. doi: 10.1016/j.foodchem.2013.01.029. Epub 2013 Jan 23.
- Background: PubMed 25033416Caligiani A, Marseglia A, Palla G. An overview on the presence of cyclopropane fatty acids in milk and dairy products. J Agric Food Chem. 2014 Aug 6;62(31):7828-32. doi: 10.1021/jf4057204. Epub 2014 Jul 24.
- Background: PubMed 23754307Sledzinski T, Mika A, Stepnowski P, Proczko-Markuszewska M, Kaska L, Stefaniak T, Swierczynski J. Identification of cyclopropaneoctanoic acid 2-hexyl in human adipose tissue and serum. Lipids. 2013 Aug;48(8):839-48. doi: 10.1007/s11745-013-3806-2. Epub 2013 Jun 11.
- Background: PubMed 22916929Bichi E, Toral PG, Hervas G, Frutos P, Gomez-Cortes P, Juarez M, de la Fuente MA. Inhibition of ∆9-desaturase activity with sterculic acid: effect on the endogenous synthesis of cis-9 18:1 and cis-9, trans-11 18:2 in dairy sheep. J Dairy Sci. 2012 Sep;95(9):5242-5252. doi: 10.3168/jds.2012-5349.
- Background: PubMed 21637024Jones SE, Whitehead K, Saulnier D, Thomas CM, Versalovic J, Britton RA. Cyclopropane fatty acid synthase mutants of probiotic human-derived Lactobacillus reuteri are defective in TNF inhibition. Gut Microbes. 2011 Mar-Apr;2(2):69-79. doi: 10.4161/gmic.2.2.15282. Epub 2011 Mar 1.
- Background: PubMed 23929455Kadegowda AK, Burns TA, Pratt SL, Duckett SK. Inhibition of stearoyl-CoA desaturase 1 reduces lipogenesis in primary bovine adipocytes. Lipids. 2013 Oct;48(10):967-76. doi: 10.1007/s11745-013-3823-1. Epub 2013 Aug 9.
- Background: PubMed 27003900Mika A, Stepnowski P, Chmielewski M, Malgorzewicz S, Kaska L, Proczko M, Ratnicki-Sklucki K, Sledzinski M, Sledzinski T. Increased Serum Level of Cyclopropaneoctanoic Acid 2-Hexyl in Patients with Hypertriglyceridemia-Related Disorders. Lipids. 2016 Jul;51(7):867-73. doi: 10.1007/s11745-016-4141-1. Epub 2016 Mar 22.
- Background: PubMed 22427892Schneider AC, Beguin P, Bourez S, Perfield JW 2nd, Mignolet E, Debier C, Schneider YJ, Larondelle Y. Conversion of t11t13 CLA into c9t11 CLA in Caco-2 cells and inhibition by sterculic oil. PLoS One. 2012;7(3):e32824. doi: 10.1371/journal.pone.0032824. Epub 2012 Mar 12.
- Background: PubMed 9409147Grogan DW, Cronan JE Jr. Cyclopropane ring formation in membrane lipids of bacteria. Microbiol Mol Biol Rev. 1997 Dec;61(4):429-41. doi: 10.1128/mmbr.61.4.429-441.1997.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele Del Rio, Professor principal investigator
Department of Food and Drugs
Augusta Caligiani, Professor principal investigator
Department of Food and Drugs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPFA-rich foods in people with Biological Availability, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03612700, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.