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

Helene Bohnert, Max Maurer, Philip C Calder, Johann Pratschke, Paul Thul, Verena Müller, Helene Bohnert, Max Maurer, Philip C Calder, Johann Pratschke, Paul Thul, Verena Müller

Abstract

Background: Data 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.

Methods: This 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.

Results: BMI 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.

Conclusions: The 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 registration: www.clinicaltrials.gov , registration number: NCT00530738.

Keywords: Fish oil; Home parenteral nutrition; Lipid emulsion; N-3 polyunsaturated fatty acids.

Conflict of interest statement

Authors’ information

Not applicable

Ethics approval and consent to participate

This study was approved by the ethics committee of the federal city state Berlin, Landesamt für Gesundheit und Soziales (LAGeSo), reference number EK6 194/07. Written informed consent was obtained from all participants prior to any study procedure.

Consent for publication

Not applicable.

Competing interests

PCC has received speaking honoraria from B. Braun. For conflict of interest see “funding sources”. Otherwise the authors have no conflict of interest to declare.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of study patients. Figure displays the number of patients screened, randomised and included for ITT and PP / FAS analyses. Nine patients of the ITT population were excluded from PP analysis because of premature study termination due to severe protocol deviation (N = 1), withdrawal of informed consent (N = 2) or serious adverse events (SAEs; N = 6). SAEs leading to premature study discontinuation were not investigational product related but required discontinuation of study medication due to necessary hospitalisation

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