Abstract
BackgroundData on the use of lipid emulsions containing fish-oil (FO) derived n-3 polyunsaturated fatty acids (n-3 PUFAs) in addition to medium- and long-chain triglycerides (MCT/LCT) for long-term home parenteral nutrition (HPN) are limited. This study aimed to compare HPN regimens containing either MCT/LCT/FO-derived n-3 PUFAs (test group) or MCT/LCT (control group) with respect to efficacy and safety during 8 weeks of HPN using a non-inferiority trial design with change of body mass index (BMI) as primary endpoint.MethodsThis prospective, randomized, double-blind study was conducted at the Charité, Berlin, Germany, from 02/2008 until 01/2014. Adult patients (n = 42; aged 18 to 80 years) requiring HPN for at least 8 weeks were randomly assigned to the test or control group. Assessments included weight, height, physical examination (cardiovascular system, abdomen, respiratory tract, liver, spleen, kidney, urine tract, skin, mucous membrane, neurology, psyche, musculoskeletal system, lymph nodes), bio impedance analysis, calorimetry, blood samplings (haematology, biochemistry, fatty acid analysis) and quality of life questionnaire.ResultsBMI increased in both groups with 8 weeks of HPN (ΔBMI(test group) = 1.3 ± 1.1 kg/m2; ΔBMI(control group) = 0.6 ± 0.9 kg/m2) demonstrating non-inferiority of the test regimen regarding nutritional efficacy. Assessment of secondary efficacy endpoints revealed that after 8 weeks of HPN with the test regimen, the proportion of n-3 PUFAs in serum, platelet and red blood cell phospholipids significantly increased, while the proportion of n-6 PUFAs decreased. The fatty acid pattern in the control group remained mostly stable. No statistically significant differences were detected between groups regarding inflammatory markers or quality of life. Laboratory parameters reflecting the safety endpoints liver function, bone metabolism, renal function, metabolic activity, lipid metabolism, coagulation and haematology were stable in both groups and no group differences were detected regarding (serious) adverse events.ConclusionsThe HPN regimen prepared with MCT/LCT/FO-derived n-3 PUFAs was at least as efficient in maintaining or even improving nutritional status during HPN as the control MCT/LCT regimen. Administration of FO-derived n-3 PUFAs for 8 weeks altered the fatty acid pattern of serum, platelet and red blood cell phospholipids. Both regimens were safe and well tolerated.Trial registrationwww.clinicaltrials.gov, registration number: NCT00530738.
Highlights
Home parenteral nutrition (HPN) was first introduced in the early 1970s and is nowadays an established therapy in the home care setting in western countries, as morbidity and mortality associated with home parenteral nutrition (HPN) are low [1]
During the last decade it has been recognized that lipid emulsions administered as part of the PN regimen function as a source of energy: lipid emulsions provide physiologically active polyunsaturated fatty acids (PUFAs), namely n-6 Polyunsaturated Fatty Acids (PUFA) and n-3 PUFAs
Test and control lipid emulsions only differed in terms of lipid composition: the test lipid emulsion provided a mixture of Medium-chain triglycerides (MCT), long-chain triglycerides (LCT) and FO-derived n-3 PUFAs (EPA and Docosahexaenoic acid (DHA)) in a ratio of 5:4:1, while the control lipid emulsion provided a mixture of MCT and LCT in a 1:1 ratio
Summary
Home parenteral nutrition (HPN) was first introduced in the early 1970s and is nowadays an established therapy in the home care setting in western countries, as morbidity and mortality associated with HPN are low [1]. Mediators derived from the n-6 PUFA arachidonic acid (2-series prostaglandins and thromboxanes, 4-series leukotrienes) generally exert pro-inflammatory effects, while n-3 PUFAs are converted into far less inflammatory mediators (3-series prostaglandins and thromboxanes, 5-series leukotrienes) and even to mediators that are anti-inflammatory and inflammation resolving (e.g. resolvins, protectins, maresins) (reviewed in [6,7,8]). Depending on their content of n-6 PUFAs and n-3 PUFAs, lipid emulsions can exert influence on inflammatory and immune functions [9, 10]. This study aimed to compare HPN regimens containing either MCT/LCT/FO-derived n-3 PUFAs (test group) or MCT/LCT (control group) with respect to efficacy and safety during 8 weeks of HPN using a non-inferiority trial design with change of body mass index (BMI) as primary endpoint
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