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

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.

Study Overview

• Status: Terminated
• Conditions: Intestinal Diseases
• Intervention / Treatment: Drug: soybean oil (SO)-based IVFE (Medialipide); Drug: fish oil (FO)-containing IVFE (Lipidem)

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69002
    • Hospices Civils de Lyon
  • Pierre Bénite, France, 69495
    • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: soybean oil (SO)-based IVFE (Medialipide)	Drug: soybean oil (SO)-based IVFE (Medialipide); The soybean oil (SO)-based IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
Active Comparator: fish oil (FO)-containing IVFE (Lipidem)	Drug: fish oil (FO)-containing IVFE (Lipidem); The fish oil (FO)-containing IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at Day 0 (at recruitment time)
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.	at Day 90
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.	at Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at Day 0
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.	at Day 0
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.	at Day 90
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.	at Day 90
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.	at Day 180
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.	at Day 180
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.	at Day 0
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.	at Day 0
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.	at Day 90
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.	at Day 90
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.	at Day 180
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.	at Day 180

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Didier Barnoud, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 8, 2017
• Study Completion (Actual): September 8, 2017

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: essential fatty acids; parenteral nutrition; transepidermal water loss; skin barrier function; intravenous fat emulsions
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: 2012-786