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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| soybean oil (SO)-based IVFE (Medialipide) | Active Comparator |
| |
| fish oil (FO)-containing IVFE (Lipidem) | Active Comparator | fish oil (FO)-containing IVFE (Lipidem) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soybean oil (SO)-based IVFE (Medialipide) | Drug | The soybean oil (SO)-based IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Barnoud, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Lyon | 69002 | France | |||
| Centre Hospitalier Lyon Sud |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D013024 | Soybean Oil |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| fish oil (FO)-containing IVFE (Lipidem) | Drug | The fish oil (FO)-containing IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. |
|
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 |
| Pierre-Bénite |
| 69495 |
| France |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |