- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02883777
Effect of a High Protein and Low Glycemic Index Diet on Kidney Transplant Recipients
Effect of a High Protein and Low Glycemic Index Diet on Kidney Transplant
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Kidney transplantation is the greater renal replacement therapy and, compared with dialysis,is associated with better quality of life and reduced costs over time. However, it is well known that significant weight gain and obesity are very common after kidney transplantation, mainly during the first year after transplant. Besides, obesity is a risk factor for the development of cardiovascular complications, new-onset diabetes after transplantation and it is associated with graft loss. The use of immunosuppressive medications, the break of dietary restrictions associated with dialysis period and improvements in appetite are acceptable causes for weight gain. However, there is a lack of evidence for effective nutritional interventions to prevent weight gain after kidney transplant.
In this context, it is well known that high-protein and low glycemic index diets are effective for body weight loss and subsequent weight maintenance. Moreover, protein generally exerts a better satiety effect than carbohydrates and lipids. So that, considering that there is a need to develop effective interventions to minimize the negative impact of weight gain and obesity on kidney transplant outcomes, a randomized clinical trial, that evaluate the effect of a high protein and low glycemic index diet (as a nutritional intervention) is likely to be effective in preventing weight gain after kidney transplantation.
This study is a randomized clinical trial, which will follow and evaluate kidney transplant recipients during one year after transplantation. There will be two groups: a control group (60 patients) and the intervention group (60 patients). The dietitian visits will happen monthly at the first six months and twice in the last six months. The study assessments (weight, anthropometry, body composition and biochemistry) will be performed during these visits. Potential participants will be identified during their initial two months following transplantation. Eligible transplant recipients will be invited to participate, given detailed information about the trial and, if agreeable, will be asked to provide written informed consent. Participants will be randomized to receive either nutrition intervention with a high-protein and low glycemic index diet or an standard nutrition protocol. This randomization will be performed by a statistical consultant using randomization.com site. The length of the study will be 1 year for each patient, so that the assessment of anthropometry, including measures of weight (monthly) and body composition (every three months) will be performed by one specialist renal dietitian. Laboratory staff will perform all laboratories testing, including serum and urine creatinine (monthly), glycemia, cholesterol, HDL-cholesterol, triglycerides, glycated hemoglobin and uric acid (each three months), high-sensitivity C- reactive protein (baseline and 6th month) and 24-h urine test with albumin, protein, creatinine and urea excretion (every three months for intervention group and at baseline, 3rd, 6th and 12th month for control group). Demographic and clinical data will be assessed at the first dietitian visit. Body weight and height of patients will be obtained and body mass index (BMI) (kg/m2) will be calculated. Waist circumference will be measured midway between the lowest rib margin and the iliac crest, with flexible, nonstretched fiberglass tape. This evaluation will be made every visit (monthly in the first 6 months and twice in the last 6 months). Body fat percentage (assessed each three months) will be measured by using tetrapolar bioimpedance and basal metabolic rate will be evaluated by indirect calorimetry at baseline and 6 months later. All the anthropometric assessment will be performed with the patient fasting, wearing light clothing, without contact with metals and without shoes. The prescription of the diet will be calculated by using nutritional table by software version. It will be considered 1,3g /kg/day of protein and the glycemic index will be estimated with glucose as standard food. Energy intake will be assessed by a 24-h recall on the day of each dietitian visit by the research dietitian. Diet composition also will be analyzed by using nutritional table by software and will be made in every visit. Satiety levels will be assessed each three months for intervention group and only at baseline for control group by using a visual analogue scale of appetite.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Kidney transplant recipients
Exclusion Criteria:
- Younger than 18
- Prior Transplant
- Multiple organ transplant
- Cancer
- Women in pregnancy or lactation period
- Recipients of living donors
- Urinary albumin excretion> 300 mg / 24h.
- Glomerular filtration rate <30 mL / min / 1.73
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High Protein and Low Glycemic Index Diet
A protocol of a high protein and low glycemic index diet.
|
It will be evaluated a type of high protein diet with 1,3g/kg/day in kidney transplant recipients over 1 year after transplantation.
|
ACTIVE_COMPARATOR: Conventional Diet
A protocol of a conventional diet.
|
Conventional diet over 1 year after transplantation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Change
Time Frame: Baseline, 1st month, 2nd month, 3rd month, 4th month, 5th month, 6th month, 9th month and 12th month.
|
Digital Balance
|
Baseline, 1st month, 2nd month, 3rd month, 4th month, 5th month, 6th month, 9th month and 12th month.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Composition Change
Time Frame: Baseline, 3rd month, 6th month, 9th month and 12th month.
|
Bioelectrical impedance analysis
|
Baseline, 3rd month, 6th month, 9th month and 12th month.
|
Basal Metabolic Rate
Time Frame: Baseline and 6th month.
|
Indirect Calorimetry
|
Baseline and 6th month.
|
Satiety
Time Frame: Baseline, 3rd month, 6th month, 9th month and 12th month for intervention group and at baseline for control group.
|
Visual analogue scale of appetite
|
Baseline, 3rd month, 6th month, 9th month and 12th month for intervention group and at baseline for control group.
|
Kidney function
Time Frame: 12 months
|
Kidney function will be assessed monthly over one year through serum creatinine with estimated glomerular filtration rate by Modification of Diet in Renal Disease equation.
|
12 months
|
Glycated hemoglobin
Time Frame: Baseline, 3rd month, 6th month, 9th month and 12th month.
|
Glycated hemoglobin Laboratory Test
|
Baseline, 3rd month, 6th month, 9th month and 12th month.
|
Lipid Profile
Time Frame: Baseline, 3rd month, 6th month, 9th month and 12th month.
|
Total cholesterol level
|
Baseline, 3rd month, 6th month, 9th month and 12th month.
|
Inflammation
Time Frame: Baseline and 6th month.
|
High-Sensitivity C-Reactive Protein
|
Baseline and 6th month.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elis Forcellini Pedrollo, Master, Hospital de Clinicas de Porto Alegre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 160121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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