Effect of an intensive nutrition intervention of a high protein and low glycemic-index diet on weight of kidney transplant recipients: study protocol for a randomized clinical trial

Abstract

BackgroundExcessive weight gain is commonly observed within the first year after kidney transplantation and is associated with negative outcomes, such as graft loss and cardiovascular events. The purpose of this study is to evaluate the effect of a high protein and low glycemic-index diet on preventing weight gain after kidney transplantation.MethodsWe designed a prospective, single-center, open-label, randomized controlled study to compare the efficacy of a high protein (1.3–1.4 g/kg/day) and low-glycemic index diet versus a conventional diet (0.8–1.0 g/kg/day of protein) on preventing weight gain after kidney transplantation. A total of 120 eligible patients 2 months after transplantation will be recruited. Patients with an estimated glomerular filtration rate through the modification of diet of renal disease (MDRD) formula < 30 mL/min/1.73 m2 or urinary albumin excretion > 300 mg/24 h will be excluded. Patients’ diets will be allocated through simple sequential randomization. Patients will be followed-up for 12 months with nine clinic appointments with a dietitian and the evaluations will include nutritional assessment (anthropometrics, body composition, and resting metabolic rate) and laboratory tests. The primary outcome is weight maintenance or body weight gain under 5% after 12 months. Secondary outcomes include body composition, resting metabolic rate, satiety sensation, kidney function, and other metabolic parameters.DiscussionDiets with higher protein content and lower glycemic index may lead to weight loss because of higher satiety sensation. However, there is a concern about the association of high protein intake and kidney damage. Nevertheless, there is little evidence on the impact of high protein intake on long-term kidney function outcome. Therefore, we designed a study to test if a high protein diet with low-glycemic index will be an effective and safe nutritional intervention to prevent weight gain in kidney transplant patients.Trial RegistrationClinicalTrials.gov identifier, NCT02883777. Registered on 3 August 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2158-2) contains supplementary material, which is available to authorized users.

Protein Intake, Fatigue and Quality of Life in Stable Outpatient Kidney Transplant Recipients

“…The Kidney Disease Improving Global Outcomes (KDIGO) guideline for CKD patients recommends to avoid excessive protein intake (>1.3 g/kg/d) in non-diabetic CKD-patients with an eGFR > 30 mL/min/1.73 m 2 [50]. Currently, no specific recommendations are available for KTR, but an ongoing dietary intervention study in 120 KTR, aiming to evaluate the effect of a high-protein (1.3-1.4 g/kg/d) low-glycemic-index diet on prevention of post-transplant weight gain, may provide more insight in the optimal protein intake after kidney transplantation [51]. With the high prevalence of overweight, obesity and its cardio-metabolic derangement, as well as the high risk of malnutrition, tailored dietary advice in collaboration with a renal dietician is of paramount importance.…”

“…We included 730 KTR with a study visit at a median of 4.1 [IQR 1.0-11.0] years after transplantation. Subjects were 58 [48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64][65] years of age, 57% were male, and mean eGFR was 51.2 ± 17.9 mL/min/1.73 m 2 . A combined organ transplantation was performed in 20 KTR, of which 17 received a combined kidney-pancreas transplantation and 3 received a combined kidney-liver transplantation.…”

Effects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: Study protocol for a randomized clinical trial

“…Patients with KTx in the present clinical trial will undergo an individualized nutritional intervention for 12 months after surgery. This period of nutritional intervention was selected based on previous studies, which demonstrated that protein intake is associated with maintenance of kidney function in the first year post-KTx [30][31][32]. However, studies on the assessment of the impact of dietary protein intake in post-KTx patients remain scarce and controversial [33][34][35][36].…”

Management of metabolic alterations in adult kidney transplant recipients: A joint position statement of the Italian Society of Nephrology (SIN), the Italian Society for Organ Transplantation (SITO) and the Italian Diabetes Society (SID)

“…In a very small study that assessed the effect of an intensive lifestyle intervention comprising physical exercise, behavioural interventions and nutritional guidance in obese KTRs, after 12 months the intervention group was weight-stable and had improvements in body composition (greater lean mass), whereas the BMI of patients in the control group increased on average from 38 to 46 kg/m 2 [144]. Trials assessing the effect of lifestyle interventions on the prevention of weight gain after KT are currently ongoing [102,145].…”