Efficacy of a long-term home parenteral nutrition regimen containing fish oil-derived n-3 polyunsaturated fatty acids: a single-centre, randomized, double blind study

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.Electronic supplementary materialThe online version of this article (10.1186/s12937-018-0419-x) contains supplementary material, which is available to authorized users.

Composition and Functionality of Lipid Emulsions in Parenteral Nutrition: Examining Evidence in Clinical Applications

“…FOLE administration after abdominal surgery is reported to modulate increased EPA content of plasma FA concentration (Morlion et al, 1996;Linseisen et al, 2000;Klek et al, 2003;Grimm et al, 2006;Senkal et al, 2007;Wichmann et al, 2007;Berger et al, 2008), platelets (Roulet et al, 1997;Bohnert et al, 2018), and erythrocytes (Klek et al, 2003;Senkal et al, 2007;Bohnert et al, 2018). Similarly, infusion of FOLE in sepsis patients reflected in increased n-3 FAs in plasma (Mayer et al, 2003a;Mayer et al, 2003b;Wang et al, 2008;Barbosa et al, 2010) and in mononuclear leukocyte membrane (Wachtler et al, 1997).…”

Calidad de vida de las personas adultas con nutrición parenteral ingresadas en hospitalización domiciliaria: revisión sistemática

“…Todos los revisados fueron ensayos clínicos controlados aleatorizados; la filiación fue en 2 de ellos británica (17,18) y en otros 2 estadounidense (14,19). Alemania y Canadá presentaron 1 trabajo (13,15). En uno de los ensayos no figuraba el país de filiación (16).…”

“…En 2 de los ensayos la nutrición contenía algún fármaco: teduglutida (16) y glutamina (17). En el estudio de Bohnert et al (13), se adicionó, a la nutrición parenteral, ácidos grasos poliinsaturados n-3.…”

“…En cuanto a la forma y frecuencia de administración, se informó en 4 estudios (13,(15)(16)(17): siendo la administración vía catéter la elegida en 2 de ellos (13,17). En 3 de los 7 estudios (14,18,19), no constaba la forma de administración utilizada.…”

“…Bohnert et al (13), emplearon un cuestionario específico para las neoplasias, el EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life) y en el trabajo de Jeppesen et al (16) se utilizó el específico para el síndrome de intestino corto, SBS-QoL (Short Bowel Syndrome-Quality of Life).…”