TABLE 3.
Summary of RCTs- Nutritional interventions.
| First author, year (country of origin) | Sample characteristics Tx-type, total N, n per group, % male, age (y) (mean (sd) or median (range)) |
Intervention(s) and measurement points | Effectiveness Outcomes | Results – Effectiveness outcomes ↑ = significant increase ↓ = significant decrease ≈ no difference |
Results – feasibility outcomes | |
|---|---|---|---|---|---|---|
| 1 | Grat, 2017 (Poland) | Liver Tx candidates N = 55 |
90-day mortality rate | I ≈ C | Enrolment: 209/491 (43%) eligible for participation; 55/209 (26%) of eligible patients participated. Refusal to participate probably due to administrational factors | |
| I n = 26 81% male Age 52 (47–58) |
I: once daily intake of a 4-strain probiotic preparation before breakfast (ProBacti 4 Enteric®: 3 × 109 colony-forming units of Lactococcus lactis PB411 (50.0%), Lactobacillus casei PB121 (25.0%), Lactobacillus acidophilus PB111 (12.5%), and Bifidobacterium bifidum PB211 (12.5%) from enrolment until transplantation. Duration of intervention was <2–>10 weeks depending upon timing Tx | 30-day and 90-day infection rate | I ↓ C | Attrition: 50/55 ((91%) completed (I 24/26 (92%); C 26/29 (90%)). Dropouts (n = 5) all discontinued treatment Post-Tx outcomes available of I: 21/26 (81%) and C: 23/29 (79%) | ||
| C n = 29 74% male Age 50 (35–61) |
C: placebo | 5-days post-Tx: - AST - ALT - Bilirubin concentration - INR |
I ↑ C I ↑ C I ↓ C I ≈ C |
Fidelity (participants): I 2/26 (8%) and C: 3/29 (10%) discontinued treatment | ||
| Assessments: - Baseline - Pre-Tx: follow-up with intervals of 10 weeks - Post-Tx: 90 days follow-up |
Pre-transplant: - Waitlist mortality - Hospitalizations - Infections - Complications |
None I ≈ C I ≈ C I ≈ C |
Fidelity (interventionist): NR | |||
| Post-transplant - Primary non-function - Early allograft dysfunction - Complications |
I ≈ C I ≈ C I ≈ C |
Acceptability: NR | ||||
| MELD-score changes | I ≈ C | Safety: NR | ||||
| CTP changes | I ≈ C | |||||
| 2 | Plank, 2015 (New Zealand) | Liver Tx candidates N = 101 |
Body composition - Body weight (kg) - Total body protein - Total body fat |
I ≈ C I ≈ C I ≈ C |
Enrolment: NR | |
| I n = 52 Male 63% Age 53 (25–68) |
I: daily intake of immuno-nutrition, two 74 g sachets per day until the day of transplant, consisting of 7.5 g arginine, 2 g omega-3 fatty acids + 0,8g Ribonucleic acid. for 56–65 days (median) | Muscle function - Hand grip strength - Respiratory muscle strength |
I ≈ C I ≈ C |
Attrition: 101/120 (84%) completed (I 52/60 (87%); C 49/60 (82%)). Dropouts: I: delisting (n = 8), C: death (n = 4), delisting (n = 7) | ||
| C n = 49 Male 73% Age 50 (22–59) |
C: daily intake with a similar amount of an isocaloric, but not isonitrogenous, control product | Plasma phosphatidyl-choline fatty acids | I ↑ C at pre-Tx and day 10 measurements | Fidelity (participants): NR | ||
| Assessments: - Baseline - Prior to Tx - 10, 30, 90, 180, 360 days after Tx |
Fatigue (NR) | I ≈ C | Fidelity (interventionist): NR | |||
| Graft rejection | I ≈ C | Acceptability: NR | ||||
| Length of stay at ICU | I ≈ C | Safety: intolerance to immune-nutrition in four participants | ||||
| Length of stay at hospital | I ≈ C | |||||
| 3 | Eguchi, 2011 (Japan) | Living donor Liver TX candidates N = 50 |
Infectious complications | I ↓ C | Enrolment: NR | |
| I n = 25 52% male Age 56 (33–66) |
I group 1: 2 days preoperative and group 2: 2 weeks post-operative synbiotic therapy (Bifidobacteriu breve, Lactobacillus casei and Galactooligosa charides ) | Mortality | I ≈ C | Attrition: NR | ||
| C n = 25 64% male Age 57 (25–68) |
C: placebo | Length of stay at ICU | I ≈ C | Fidelity (participants): NR | ||
| Assessments: Not specified |
Length of stay at hospital | I ≈ C | Fidelity (interventionist): NR | |||
| Acceptability: NR | ||||||
| Safety: all participants tolerated synbiotic therapy | ||||||
| 4 | Park, 2003 (United States) | Heart Tx candidates with BMI > 25 kg/m2
N = 43 |
All participants had one consultation session by a graduate student in clinical psychology under the supervision of the study’s registered dietitian, who provided the recommendations such as energy balance | Body weight change | I ↑ C | Enrolment: 43/54 (80%) of referred patients |
| I n = 21 81% male Age 47.8 (±8.5) |
I : 3-months weight-loss program comprised of bibliotherapy (written, 20-page manual containing brief lessons about cognitive and behavioral weight loss strategies), and telephone-based counseling (1x/week, 15–20 min) delivered by a therapist who has a bachelor’s or master’s degree in psychology. | Attrition: 36/43 (84%) completed (I 17/21 (81%); C 19/22 (86%) | ||||
| C n = 22 68% male Age 48.1 (±9.4) |
C: 3-months weight-loss program comprised of bibliotherapy without counseling | Fidelity (participants): I returned more food diaries than C, but not significant; I returned more postcards than C, but not significant | ||||
| Assessments: - Pre-intervention - Post-intervention |
Fidelity (interventionist): NR | |||||
| Acceptability: NR | ||||||
| Safety: NR | ||||||
| 5 | Forli, 2001(a) (Norway) | Lung Tx candidates N = 65 |
Change in body weight. | I ↑ C1 and C2 | Enrolment: 6/71(8%) of eligible patients excluded for various reasons: refused intervention (n = 1), dietary wishes (n = 1), absent during night/weekend (n = 1), short hospital stay (n = 1), death (n = 1). | |
| I n = 18 44% male Age 49 (44–53) |
I: intensified nutritional support comprised of energy-rich diet and supplements, provided by a dietician during hospital stay | BMI (kg/m2) | C1 ↓ I and C2 | Attrition: 49/65 (75%) completed. Drop-outs due to: not willing to record data (n = 1), missing data (n = 3), oedema (n = 2), death (n = 1) | ||
| C1 n = 19 53% male Age 48 (44–52) |
C1: normal hospital diet | Total energy intake/kg | C2 ↓ I and C1 | Fidelity (participants): NR | ||
| C2 n = 28 43% male Age 51 (48–55) |
C2: normal weight lung Tx candidates | Total energy intake/REE predicted | I ↑ C1 and C2, C1 ↑ C2 | Fidelity (interventionist): NR | ||
| Assessments: - During hospitalization for lung Tx screening, exact moments NR |
Acceptability: NR | |||||
| Safety: NR | ||||||
| 6 | Forli, 2001(b) (Norway) | Lung Tx candidates with underweight N = 71 |
Body composition - Change in body weight - Change in Fat mass - Change in Fat free mass |
↑ in I (+2.9 kg) and C1 (+2.3 kg) group, not in C2 group I ↑ C1 ≈ C2 C1 ↑I ≈ C2 |
Enrolment: NR | |
| I n = 21 48% male Age 47 (28–59) |
I: intensified sessions dietary counselling with suggestions for individual meal plans facilitating weight gain, booklet with dietary information and recipes, supplements, and support by telephone by the dietitian each month after hospital discharge. Mean intervention time was 22 weeks. | Blood samples - Albumin concentration - Phosphate concentration |
I ≈ C1 ≈ C2 I ≈ C1 ≈ C2 |
Attrition: 54/71 (76%) completed (1 18/21 (86%); C1 13/21 (62%); C2 23/29 (79%)). Dropouts: I and C1 death (n = 8), Tx (n = 3), infection (n = 14); C2 death (n = 2), Tx (n = 4), infection (n = 7) | ||
| C1 n = 21 48% male Age 46 (25–60) |
C1: one session of individual dietary counselling with the dietitian. No follow-ups. The mean intervention time was 20 weeks. |
Lung function test: - PaO2 - PaCO2 - FVC - FEV1 - TLCO |
I ↓ C1 ≈ C2 I ≈ C1 ≈ C2 I ≈ C1 ≈ C2 I ≈ C1 ≈ C2 I ≈ C1 ≈ C2 |
Fidelity (participants): NR | ||
| C2 n = 29 41% male Age 52 (26–60) |
C2: normal weight Lung Tx candidates | Exercise testing: - handgrip strength - 6MWT |
I ≈ C1 ≈ C2 I ≈ C1 ≈ C2 |
Fidelity (interventionist): NR | ||
| Assessments: - Pre-intervention - 4–5 months after discharge |
Acceptability: NR | |||||
| Safety: NR | ||||||
| 7 | Le Cornu, 2000 (United Kingdom) | Liver Tx candidates N = 82 |
No information who provided the advice in both groups nor the number of sessions | Biochemical parameters - Bilirubin - Creatinine - Urea - Alkaline phosphatase - Aspartate transaminase - INR |
≈ within ≈ within I and C ↑ within I; ≈ within C ≈ within I; ↓ within C ≈ within I and C ≈ within I; ↑ within C |
Enrolment: 116/328 (35%) patients were eligible, 82/116 (71%) of eligible patients consented |
| I n = 42 69% male Age 52 (27–67) |
I: Standard dietary advice to increase energy intake on top of the dietary recommendations they already had to follow for underlying medical conditions and daily enteral supplementation (750 calories out of 20 g protein and 33.5 g fat). | Anthropometric measurements: - Mid-arm circumference - Triceps skinfold thickness |
I ≈ C I ≈ C |
Attrition: 80-28 (98%) completed (I 41/42 (98%); C 39/40 (98%)). Dropouts due to I: lost to follow-up n = 1); C: delisted (n = 1) | ||
| C n = 40 79% male Age 50 (24–68) |
C: Standard dietary advice to increase energy intake on top of the dietary recommendations they already had to follow for underlying medical conditions. | Handgrip strength | I ≈ C | Fidelity (participants): NR | ||
| Assessments: - Screening - Monthly follow-up until Tx or death |
Energy Intake | I ≈ C | Fidelity (interventionist): NR | |||
| Survival (pre-transplant) | I ≈ C | Acceptability: NR | ||||
| Days on ventilatory support | I ≈ C | Safety: NR | ||||
| Length of ICU stay | I ≈ C | |||||
| Length of Hospital stay | I ≈ C |
I, Intervention group; C, comparator group; Tx, transplantation; NR, not reported; AST, asparate; ALT, alanine aminotransferase; INR, Internationalized Normalized Ratio; MELD, Model for End-stage Liver Disease; CTP, Chil-Turcotte-Pugh; ICU, Intensive Care Unit; BMI, Body Mass Index; PaO2, Arterial O2; PaCO2, Arterial CO2; FVC, Forced Vital Capacity; FEV1, Forced Expiratory Volume/1s; TLCO, Lung transfer factor carbon monoxide; 6MWT, six Minutes Walking Test.