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Nutritional counseling frequency and baseline food pattern predict implementation of a high-protein and high-polyunsaturated fatty acid dietary pattern: 1-year results of the randomized NutriAct trial.
Pletsch-Borba, L, Wernicke, C, Apostolopoulou, K, Spira, D, Pohrt, A, Hornemann, S, Gerbracht, C, Pfeiffer, AFH, Spranger, J, Mai, K
Clinical nutrition (Edinburgh, Scotland). 2021;(11):5457-5466
Abstract
BACKGROUND & AIMS NutriAct is a 36-month randomized controlled multi-center trial designed to analyze the effects of a food pattern focusing on a high-protein and high-unsaturated fatty acids (UFA) intake on healthy aging. We aimed to determine factors associated with a successful modulation of dietary pattern after 12 months in elderly participants. METHODS 502 participants were randomized into either usual care control group including dietary recommendations of the German Nutrition Society (DGE) or an intervention group, which used supplementation of rapeseed oil and specifically designed foods as well as repetitive advices to implement a food pattern based on high intake of predominantly plant proteins, UFA and fiber (NutriAct pattern). Food intake was repeatedly assessed by 3-day food records at months 0, 3, 6 and 12. Linear regression models were used to investigate determinants of basal food intake and modulation of dietary pattern during the intervention. RESULTS Food records of 242 intervention and 246 control participants (median age 66 y, 37% males) were available at baseline and were included. At baseline, high BMI was related to higher protein and saturated fatty acids and lower fiber intake. The intervention resulted in higher intake of protein, mono- and polyunsaturated fatty acids (MUFA and PUFA) and fiber, and lower carbohydrate and saturated fatty acid consumption (all p < 0.001). While individuals who were already at baseline closer to the NutriAct pattern also achieved a diet closer to the proposed pattern at month 12, the strongest absolute changes (%E) of dietary behavior were seen in those with dietary patterns further away from the proposed pattern at baseline. Attendance to nutritional sessions was crucial to change MUFA, PUFA, fiber and carbohydrate intake. CONCLUSIONS A successful modification of dietary pattern was achieved by the performed intervention within 12 months. Baseline dietary habits and attendance to nutritional sessions were substantial determinants predicting changes in dietary pattern. CLINICAL TRIAL REGISTRATION The trial was registered at German Clinical Trials Register (drks.de) as DRKS00010049.
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A multimodal nutritional intervention after discharge improves quality of life and physical function in older patients - a randomized controlled trial.
Munk, T, Svendsen, JA, Knudsen, AW, Østergaard, TB, Thomsen, T, Olesen, SS, Rasmussen, HH, Beck, AM
Clinical nutrition (Edinburgh, Scotland). 2021;(11):5500-5510
Abstract
BACKGROUND Many older hospitalized patients are at nutritional risk or malnourished and the nutritional condition is often further impaired during hospitalization. When discharged to own home, a "Nutrition Gap" often occurs, causing inadequate dietary intake, and potentially impeded recovery. Previously, cross-sectorial studies of single component nutritional intervention have shown a limited effect on clinically relevant outcomes. We hypothesized that a multimodal nutritional intervention is necessary to elicit a beneficial effect on clinically relevant outcomes. METHODS A randomized controlled trial was performed for a period of 16 weeks. At discharge, the intervention group (IG) received dietetic counselling including a recommendation of daily training, an individual nutrition plan and a package containing foods and drinks covering dietary requirements for the next 24 h. Further, a goodie-bag containing samples of protein-rich milk-based drinks were provided. Information regarding recommendations of nutritional therapy after discharge was systematically and electronically communicated to the municipality. The dietician performed telephone follow-ups on day 4 and 30 and a home visit at 16 weeks. The control group (CG) received standard treatment. The primary outcome was readmissions within 6 month, secondary outcomes were Length of Stay (LOS), Health Related Quality of Life (EQ-5D-3L), nutritional status, physical function (30s-CST) and mortality. This trial was registered under ClinicalTrials.gov Identifier no. NCT03488329. RESULTS We included 191 patients (IG: n = 93). No significant difference was seen in readmissions within 6 month (IG: 45% vs. CG: 45%, Risk Ratio (RR): 0.96 0.71-1.31, p = 0.885). At the 16-weeks follow-up more patients in the IG reached at least 75% of energy and protein requirements (82% vs. CG: 61%, p = 0,007). The energy (kcal) and protein intake (g) per kg was significantly higher in the IG (26.4 kcal/kg (±7.4) vs. 22.6 (±7.4), p = 0.0248) (1.1 g/kg (±0.3) vs. 0.9 g/kg (±0.3). Furthermore, significant lower weight loss was seen in IG (0.7 (±4.3) vs. -1.4 (±3.6), p = 0.002). A significant and clinically relevant difference was found in the EQ-5D-3L VAS-score (IG: mean 61.6 ± 16.2 vs. CG: 53.3 ± 19.3, p = 0.011) (Δ14.3 (±15.5) vs. Δ5.6 (±17.2), p = 0.002). A significant difference in mean 30s-CST in IG was also found (7.2 (±4.3) vs. 5.3 (±4.1), p = 0.010). The improvements in physical function were of clinical relevance in both groups, but significantly higher in the IG (Δ4.2 (±4.4) vs. Δ2.2 (±2.5), p = 0.008). In fact, 86% in IG experienced improvements in the 30s-CST compared with 68% in the CG (p = 0.022). LOS was found to be lower at all time points, however not significant (30 days: -3 (-8.5 to 2.5), p = 0.276, 16 weeks: -4 (-10.2 to 2.2, p = 0.204), 6 months: -3 (-9.3 to 3.3, p = 0346)). All-cause mortality was not different between groups, however RR showed a non-significantly 47% reduction at day 30 (0.53 (0.14-2.05, p = 0.499)) and a 17% reduction at 16 weeks (0.83 (0.40-1.73, p = 1.000)) in IG. Per protocol (PP) analysis revealed a non-significant decrease of 32% in readmission at 6 months (RR: 0.68 (0.42-1.08), p = 0.105). CONCLUSION The present study, using a multimodal nutritional approach, revealed no significant effect on readmissions however a significant positive effect on nutritional status, quality of life and physical function was found. The improvements in quality of life and physical function were of clinical relevance. No significant effect was found on LOS and mortality.
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QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.
Pinto, E, Nardi, MT, Marchi, R, Cavallin, F, Alfieri, R, Saadeh, L, Cagol, M, Baldan, I, Saraceni, E, Parotto, M, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(2):1025-1033
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Abstract
BACKGROUND Esophagectomy for cancer strongly impairs quality of life. The aim of this trial was to evaluate the effect of the nutritional and respiratory counseling on postoperative quality of life. METHODS At hospital discharge, patients were randomized into four groups receiving respectively: nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care. The main endpoint was the impairment in quality of life in the first month after surgery. Linear mixed effect models were estimated to assess mean score differences (MDs) in quality of life scores. RESULTS Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery. Dyspnea was similar between patients receiving vs. those not receiving respiratory counseling (MD - 3.1, 95% CI - 10.8 to 4.6). Global quality of life was clinically similar between patients receiving vs. those not receiving nutritional counseling over time (MD 0.9, 95% CI - 5.5 to 7.3), as well as in patients receiving vs. those not receiving respiratory counseling over time (MD 0.7, 95% CI - 5.9 to 7.2). CONCLUSIONS Intensive postoperative care does not affect global quality of life even if nutritional counseling reduced appetite loss.
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Protein intake, weight loss, dietary intervention, and worsening of quality of life in older patients during chemotherapy for cancer.
Regueme, SC, Echeverria, I, Monéger, N, Durrieu, J, Becerro-Hallard, M, Duc, S, Lafargue, A, Mertens, C, Laksir, H, Ceccaldi, J, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(2):687-696
Abstract
Decreased health-related quality of life (HRQoL) is common in patients with cancer. We investigated the effects of dietary intervention and baseline nutritional status on worsening of HRQoL in older patients during chemotherapy. In this randomized control trial assessing the effect on mortality of dietary advice to increase dietary intake during chemotherapy, this post hoc analysis included 155 patients with cancer at risk of malnutrition. The effects of dietary intervention, baseline Mini Nutritional Assessment item scores, weight loss, and protein and energy intake before treatment on the worsening of HRQoL (physical functioning, fatigue) and secondary outcomes (Timed Up and Go test, one-leg stance time, depressive symptoms, basic (ADL), or instrumental (IADL) activities of daily living) were analyzed by multinomial regressions. Dietary intervention increased total energy and protein intake but had no effect on any examined outcomes. Worsening of fatigue and ADL was predicted by very low protein intake (< 0.8 g kg-1 day-1) before chemotherapy (OR 3.02, 95% CI 1.22-7.46, p = 0.018 and OR 5.21, 95% CI 1.18-22.73, p = 0.029 respectively). Increase in depressive symptomatology was predicted by 5.0-9.9% weight loss before chemotherapy (OR 2.68, 95% CI 1.10-6.80, p = 0.038). Nutritional intervention to prevent HRQoL decline during chemotherapy should focus on patients with very low protein intake along with those with weight loss.
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Effects of preoperative oral single-dose and double-dose carbohydrates on insulin resistance in patients undergoing gastrectomy:a prospective randomized controlled trial.
Chen, X, Li, K, Yang, K, Hu, J, Yang, J, Feng, J, Hu, Y, Zhang, X
Clinical nutrition (Edinburgh, Scotland). 2021;(4):1596-1603
Abstract
BACKGROUND & AIMS Preoperative oral carbohydrates are strongly recommended for routine use before various elective procedures. The regimen mainly includes preoperative oral single-dose carbohydrate (2-3 h before surgery) and preoperative oral double-dose carbohydrates (10 h before surgery and 2-3 h before surgery). The choice between the two options is still controversial. METHODS A total of 139 patients with gastric cancer who underwent radical gastrectomy were recruited from a hospital in Sichuan Province, China. The patients were randomly assigned to a single-dose group (n = 70) or a double-dose group (n = 69). Insulin resistance indicators, subjective comfort indicators, inflammatory mediators, immunological indicators, postoperative recovery indexes, and complications were compared between the two groups. RESULTS There were no differences in insulin resistance indicators (fasting plasma glucose, fasting insulin, and homeostasis model assessment indexes), inflammatory mediators (C-reactive protein, interleukin-6, and tumor necrosis factor-α), immunological indicators (CD3+, CD4+, CD8+, and CD4+/CD8+) between the single-dose group and double-dose group (all P > 0.05) at preoperative day 1, preoperative 3 h, and postoperative day 1. There were no differences in subjective comfort indicators (thirst, hunger, anxiety, nausea, fatigue, and weakness) between the two groups (all P > 0.05) at preoperative day 1, preoperative 3 h, preoperative 1 h, and postoperative day 1. The postoperative recovery indexes and complications (exhaust time, liquid intake time, postoperative hospital stay, complication incidence, unplanned readmission rate, and unplanned reoperation rate 30 days after operation) did not significantly differ between the two groups (all P > 0.05). The number of preoperative nighttime urinations in the double-dose group was higher than that in the single-dose group (88.3% VS 48.5%, P < 0.001), and the number of hours of preoperative sleep in the double-dose group was lower than that in the single-dose group (4.56 ± 0.68 VS 5.71 ± 0.57, P < 0.001). CONCLUSION Oral carbohydrates administered the night before surgery did not enhance the effects of oral carbohydrates administered 2-3 h before surgery on insulin resistance, subjective comfort, inflammation, and immunity and might affect the patients' night rest. In making a decision between oral carbohydrate regimes, evening carbohydrates could be omitted. TRIAL REGISTRATION ChiCTR, ChiCTR1900020608. Registered January 10, 2019, http://www.chictr.org.cn: ChiCTR1900020608.
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Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial.
Perichart-Perera, O, Mier-Cabrera, J, Flores-Robles, CM, Martínez-Cruz, N, Arce-Sánchez, L, Alvarado-Maldonado, IN, Montoya-Estrada, A, Romo-Yañez, J, Rodríguez-Cano, AM, Estrada-Gutierrez, G, et al
Nutrients. 2021;(1)
Abstract
The aim of this study was to examine the efficacy of intensive medical nutrition therapy (MNT) plus metformin in preventing gestational diabetes mellitus (GDM) among high-risk Mexican women. An open-label randomized clinical trial was conducted. Inclusion criteria were pregnant women with three or more GDM risk factors: Latino ethnic group, maternal age >35 years, body mass index >25 kg/m2, insulin resistance, and a history of previous GDM, prediabetes, a macrosomic neonate, polycystic ovarian syndrome, or a first-degree relative with type 2 diabetes. Women before 15 weeks of gestation were assigned to group 1 (n = 45): intensive MNT-plus metformin (850 mg twice/day) or group 2 (n = 45): intensive MNT without metformin. Intensive MNT included individual dietary counseling, with ≤50% of total energy from high carbohydrates. The primary outcome was the GDM incidence according to the International Association of Diabetes Pregnancy Study Groups criteria. There were no significant differences in baseline characteristics and adverse perinatal outcomes between the groups. The GDM incidence was n = 11 (24.4%) in the MNT plus metformin group versus n = 7 (15.5%) in the MNT without metformin group: p = 0.42 (RR: 1.57 [95% CI: 0.67-3.68]). There is no benefit in adding metformin to intensive MNT to prevent GDM among high-risk Mexican women. Clinical trials registration: NCT01675310.
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Effect of Individual Nutrition Therapy and Exercise Regime on Gait Speed, Physical Function, Strength and Balance, Body Composition, Energy and Protein, in Injured, Vulnerable Elderly: A Multisite Randomized Controlled Trial (INTERACTIVE).
Han, CY, Crotty, M, Thomas, S, Cameron, ID, Whitehead, C, Kurrle, S, Mackintosh, S, Miller, M
Nutrients. 2021;(9)
Abstract
It is imperative that the surgical treatment of hip fractures is followed up with rehabilitation to enhance recovery and quality of life. This randomized controlled trial aimed to determine if an individualised, combined exercise-nutrition intervention significantly improved health outcomes in older adults, after proximal femoral fracture. We commenced the community extended therapy while in hospital, within two weeks post-surgery. The primary outcome was gait speed and secondary outcomes included physical function, strength and balance, body composition, energy and protein intake. Eighty-six and 89 participants were randomized into six months individualised exercise and nutrition intervention and attention-control groups, respectively. There were no statistically significant differences in gait speed between the groups at six and 12 months. There were no major differences between groups with respect to the secondary outcomes, except estimated energy and protein intake. This may be explained by the sample size achieved. Participants in the intervention group had greater increment in energy (235 kcal; 95% CI, 95 to 375; p = 0.01) and protein intake (9.1 g; 95% CI, 1.5 to 16.8; p = 0.02), compared with those in the control group at six months but not significant at 12 months. This study has demonstrated that providing early, combined exercise and nutrition therapy can improve dietary energy and protein intake in older adults with hip fractures.
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Post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial.
Meng, Q, Tan, S, Jiang, Y, Han, J, Xi, Q, Zhuang, Q, Wu, G
Clinical nutrition (Edinburgh, Scotland). 2021;(1):40-46
Abstract
BACKGROUND & AIMS Malnutrition frequently occurs and deteriorates in patients after surgery for gastric cancer, especially after hospital discharge, which has been consistently associated with negative outcomes. However, information regarding the impact of post-discharge nutritional interventions is poorly described. The aim of this study was thus to evaluate the impact of post-discharge oral nutritional supplements (ONS) with dietary advice compared with dietary advice alone on nutritional outcomes, including body mass index (BMI) and skeletal muscle index (SMI), sarcopenia prevalence, chemotherapy tolerance, the 90-day readmission rate, and quality of life in patients at nutritional risk after surgery for gastric cancer. METHODS Three hundred and fifty-three patients who underwent surgery for gastric cancer and were at nutritional risk (Nutritional Risk Screening 2002 [NRS 2002] score ≥3 points) in our institution were randomly assigned to receive either ONS with dietary advice or dietary advice alone (control) for 3 months after discharge. The primary endpoints were nutritional outcomes and sarcopenia prevalence; the secondary endpoints included chemotherapy tolerance, the 90-day readmission rate, and quality of life. RESULTS Three hundred and thirty-seven patients completed the study and were included in the analyses, consisting of 171 in the ONS group and 166 in the control group. The average daily intake of ONS in the intervention group was 370 mL. After 3 months of the intervention, the patients who received ONS and dietary advice had significantly less weight loss and higher BMI and SMI than those given dietary advice alone (P < 0.05). The incidence of sarcopenia was significantly lower in the ONS group than in the control group (P < 0.05). Similar number of patients in the two groups underwent postoperative chemotherapy, but the patients who received ONS and dietary advice had significantly less chemotherapy modifications, including delay, dose reduction, or termination (P < 0.05). The two groups had no significant differences in the 90-day readmission rate (P > 0.05). Regarding the quality of life, the patients who received ONS and dietary advice reported significantly less fatigue and appetite loss than those given dietary advice alone (P < 0.05), but the two groups showed no significant differences in the other outcomes (P > 0.05). CONCLUSIONS Post-discharge ONS with dietary advice in patients at nutritional risk after surgery for gastric cancer improved nutritional outcomes, skeletal muscle maintenance, chemotherapy tolerance and some quality of life variables. These findings strongly support the concept of the introduction of post-discharge ONS with dietary advice to this patient cohort.
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Lean Mass Improvement from Nutrition Education and Protein Supplementation among Rural Indian Women Living with HIV/AIDS: Results from Cluster Randomized Factorial Trial at 18-Month Follow-Up.
Carpenter, CL, Kapur, K, Ramakrishna, P, Pamujula, S, Yadav, K, Giovanni, JE, Julian, O, Ekstrand, ML, Sinha, S, Nyamathi, AM
Nutrients. 2021;(1)
Abstract
Loss of lean muscle mass impairs immunity and increases mortality risk among individuals with HIV/AIDS. We evaluated the relative contributions of protein supplementation and nutrition education on body composition among 600 women living with HIV/AIDS in rural Andhra Pradesh, India. We conducted a cluster randomized controlled 2 × 2 factorial trial lasting six months with follow up at twelve and eighteen months. Interventions occurred in the Nellore and Prakasam regions of Andhra Pradesh by trained village women, ASHA (Accredited Social Health Activists), and included: (1) the usual supportive care from ASHA (UC); (2) UC plus nutrition education (NE); (3) UC plus nutritional protein supplementation (NS); (4) combined UC plus NE plus NS. A Bioimpedance Analyzer Model 310e measured body composition. SAS 9.4 analyzed all data. Mixed models using repeated measures evaluated lean mass change from baseline as primary and fat weight and total weight as secondary outcomes. Lean mass change was significantly associated with NS (p = 0.0001), NE (p = 0.0001), and combined NS plus NE (p = 0.0001), with similar associations for secondary outcomes. Stronger associations for total weight were observed with greater ART adherence. Nutritional interventions may improve physiologic response to HIV. Significant increases in lean mass resulted from independent and combined protein supplementation and nutrition education.
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Impact of oral nutritional supplements in post-discharge patients at nutritional risk following colorectal cancer surgery: A randomised clinical trial.
Tan, S, Meng, Q, Jiang, Y, Zhuang, Q, Xi, Q, Xu, J, Zhao, J, Sui, X, Wu, G
Clinical nutrition (Edinburgh, Scotland). 2021;(1):47-53
Abstract
BACKGROUND & AIMS Guidelines on clinical nutrition recommend the use of appropriate nutritional support therapy for surgical cancer patients at risk of malnutrition both during hospital care and following discharge from the hospital. However, previous studies regarding nutritional interventions have mainly focused on patients during their hospital stay; there is limited evidence supporting the recommendation of nutritional interventions for post-discharge patients after cancer surgery, particularly those who underwent gastrointestinal cancer surgery and at high risk of malnutrition. To clearly address this issue, we designed and conducted two independent studies on two different groups of post-discharge patients at nutritional risk after gastrointestinal cancer surgery. The present study aimed to assess the impact of oral nutritional supplements (ONS) in post-discharge patients at nutritional risk following colorectal cancer surgery. Meanwhile, the sister study on the use of ONS in post-discharge patients following gastric cancer surgery will be reported separately. METHODS Between January 2017 and June 2019, post-discharge patients following colorectal cancer surgery in our institution were randomised to receive either dietary advice alone (control group) or dietary advice in combination with ONS (ONS group) for three months if they were at nutritional risk based on the tool of Nutritional Risk Screening 2002. The primary endpoints were nutritional outcomes and sarcopenia prevalence. The secondary endpoints were 90-day readmission rate, chemotherapy tolerance, and quality of life (QoL). RESULTS Of the 232 eligible patients, 212 (107 in the control group and 105 in the ONS group) completed the trial. Their data were then analyzed. The mean ONS intake was 410 mL every day. By the three-month intervention, the skeletal muscle index in the ONS group was significantly higher than that in the control group (39.75 ± 5.83 vs 38.01 ± 6.18 cm2/m2, P = 0.037), but no significant differences between the two groups were noted in weight, weight loss, body mass index, serum albumin and hemoglobin (P > 0.05). In addition, the ONS group had a significantly lower sarcopenia prevalence (28.6% vs 42.1%, P = 0.040). No significant difference between the two groups was found in the 90-day readmission rate (P > 0.05). The number of patients undergoing postoperative chemotherapy in the two groups was similar, but chemotherapy modifications, such as delay, dose reduction, or termination, were significantly reduced in the ONS group (21.2% vs 36.8%, P=0.024). However, ONS had no significant effect on QoL (P > 0.05). CONCLUSIONS In post-discharge patients at nutritional risk following colorectal cancer surgery, the use of ONS may reduce skeletal muscle loss and sarcopenia prevalence, as well as improve chemotherapy tolerance, compared with dietary advice alone. These findings underline the importance of ONS treatment in post-discharge patients at nutritional risk following colorectal cancer surgery.