search
Back to results

Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function (Tewlip)

Primary Purpose

Intestinal Diseases

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
soybean oil (SO)-based IVFE (Medialipide)
fish oil (FO)-containing IVFE (Lipidem)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Diseases focused on measuring intravenous fat emulsions, parenteral nutrition, skin barrier function, essential fatty acids, transepidermal water loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with sever chronic intestinal disease requiring long term parenteral nutrition
  • Receiving home lipid containing parenteral nutrition (LCPN), regardless of currently infused intravenous fat emulsion
  • With a stable dose of LCPN for at least 1 month at recruitment time
  • Administered at least 4 days a week through central venous access, with at least 150 mL of lipid per parenteral nutrition bag with lipid.
  • Age >18
  • Being available for 2 medical consultations in a 6 month period
  • Who gave its written informed consent to participate to the study and without legal protection
  • Social security coverage

Exclusion Criteria:

  • Lesser expected parenteral nutrition length than duration for the entire trial
  • Dermatological criteria : History of skin disease (atopic dermatitis, psoriasis) or evolving skin disease, broken or inflamed skin on the TEWL measurement site, Use of topical creams on the TEWL measurement site, Skin or systemic allergy (asthma)
  • Contraindication to one of the selected intravenous fat emulsion: Severe dyslipidemia; Uncontrolled diabetes; Sepsis; Severe hepatic impairment; Major blood clotting disorders; Egg protein, soybean, peanut or fish hyper sensibility; Serum creatinine clearance < 30 ml/min

Sites / Locations

  • Hospices Civils de Lyon
  • Centre Hospitalier Lyon Sud

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

soybean oil (SO)-based IVFE (Medialipide)

fish oil (FO)-containing IVFE (Lipidem)

Arm Description

fish oil (FO)-containing IVFE (Lipidem)

Outcomes

Primary Outcome Measures

Measurement of the transepidermal water loss (TEWL).
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
Measurement of the transepidermal water loss (TEWL).
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
Measurement of the transepidermal water loss (TEWL).
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.

Secondary Outcome Measures

Determination of erythrocyte fatty acids ω-6
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Determination of erythrocyte fatty acids ω-3
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Determination of erythrocyte fatty acids ω-6
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Determination of erythrocyte fatty acids ω-3
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Determination of erythrocyte fatty acids ω-6
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Determination of erythrocyte fatty acids ω-3
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Determination of Stratum corneum (SC) ω-3
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Determination of Stratum corneum (SC) ω-6
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Determination of Stratum corneum (SC) ω-3
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Determination of Stratum corneum (SC) ω-6
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Determination of Stratum corneum (SC) ω-3
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Determination of Stratum corneum (SC) ω-6
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.

Full Information

First Posted
August 31, 2015
Last Updated
February 27, 2018
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT02550860
Brief Title
Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function
Acronym
Tewlip
Official Title
Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
problem of enrollment
Study Start Date
January 2015 (Actual)
Primary Completion Date
September 8, 2017 (Actual)
Study Completion Date
September 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The epidermal barrier efficacy is determined by the physicochemical properties of the epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role. Inversely, the ω-3 EFAs are not found in the epidermis. For patients receiving lipid-containing parenteral nutrition (LCPN), the improvement of the epidermal barrier through the infusion of most appropriate intravenous fat emulsions (IVFE) could have many applications in clinical nutrition, mainly limiting water loss in patients receiving long-term LCPN and help in electrolyte and water balance. The objective of this interventional clinical trial is to evaluate the epidermal barrier function in patients receiving long-term LCPN comparing two compositions of IVFE: (i) soybean oil (SO)-based IVFE (Medialipide) or (ii) fish oil (FO)-containing IVFE (Lipidem). Epidermal barrier function will be assessed through the transepidermal water loss (TEWL) measurement on the skin surface, a validated marker of the epidermal barrier efficacy. The two IVFE (SO-based or FO-containing) will be compared using a randomized double blind crossover design, using patients as their own control. Each IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. Patient's epidermal and red blood cell EFA profile will be determinate in order to facilitate result interpretation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Diseases
Keywords
intravenous fat emulsions, parenteral nutrition, skin barrier function, essential fatty acids, transepidermal water loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
soybean oil (SO)-based IVFE (Medialipide)
Arm Type
Active Comparator
Arm Title
fish oil (FO)-containing IVFE (Lipidem)
Arm Type
Active Comparator
Arm Description
fish oil (FO)-containing IVFE (Lipidem)
Intervention Type
Drug
Intervention Name(s)
soybean oil (SO)-based IVFE (Medialipide)
Intervention Description
The soybean oil (SO)-based IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
Intervention Type
Drug
Intervention Name(s)
fish oil (FO)-containing IVFE (Lipidem)
Intervention Description
The fish oil (FO)-containing IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
Primary Outcome Measure Information:
Title
Measurement of the transepidermal water loss (TEWL).
Description
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
Time Frame
at Day 0 (at recruitment time)
Title
Measurement of the transepidermal water loss (TEWL).
Description
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
Time Frame
at Day 90
Title
Measurement of the transepidermal water loss (TEWL).
Description
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
Time Frame
at Day 180
Secondary Outcome Measure Information:
Title
Determination of erythrocyte fatty acids ω-6
Description
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Time Frame
at Day 0
Title
Determination of erythrocyte fatty acids ω-3
Description
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Time Frame
at Day 0
Title
Determination of erythrocyte fatty acids ω-6
Description
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Time Frame
at Day 90
Title
Determination of erythrocyte fatty acids ω-3
Description
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Time Frame
at Day 90
Title
Determination of erythrocyte fatty acids ω-6
Description
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Time Frame
at Day 180
Title
Determination of erythrocyte fatty acids ω-3
Description
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Time Frame
at Day 180
Title
Determination of Stratum corneum (SC) ω-3
Description
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Time Frame
at Day 0
Title
Determination of Stratum corneum (SC) ω-6
Description
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Time Frame
at Day 0
Title
Determination of Stratum corneum (SC) ω-3
Description
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Time Frame
at Day 90
Title
Determination of Stratum corneum (SC) ω-6
Description
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Time Frame
at Day 90
Title
Determination of Stratum corneum (SC) ω-3
Description
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Time Frame
at Day 180
Title
Determination of Stratum corneum (SC) ω-6
Description
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Time Frame
at Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with sever chronic intestinal disease requiring long term parenteral nutrition Receiving home lipid containing parenteral nutrition (LCPN), regardless of currently infused intravenous fat emulsion With a stable dose of LCPN for at least 1 month at recruitment time Administered at least 4 days a week through central venous access, with at least 150 mL of lipid per parenteral nutrition bag with lipid. Age >18 Being available for 2 medical consultations in a 6 month period Who gave its written informed consent to participate to the study and without legal protection Social security coverage Exclusion Criteria: Lesser expected parenteral nutrition length than duration for the entire trial Dermatological criteria : History of skin disease (atopic dermatitis, psoriasis) or evolving skin disease, broken or inflamed skin on the TEWL measurement site, Use of topical creams on the TEWL measurement site, Skin or systemic allergy (asthma) Contraindication to one of the selected intravenous fat emulsion: Severe dyslipidemia; Uncontrolled diabetes; Sepsis; Severe hepatic impairment; Major blood clotting disorders; Egg protein, soybean, peanut or fish hyper sensibility; Serum creatinine clearance < 30 ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Barnoud, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

Learn more about this trial

Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function

We'll reach out to this number within 24 hrs