NCT02883777

Brief Summary

This study is a randomized clinical trial, which will follow and evaluate 120 kidney transplant recipients over one year. There will be two groups: a control group and the intervention group. The dietitian visits will happen monthly during the first six months and twice in the last six months.The intervention group will receive a high-protein and low glycemic index diet (1,3g/kg/day of protein) and the control group will keep following the hospital standard protocol. The study assessments (weight, anthropometry and biochemistry) will be performed during these visits over one year after the randomization period.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

August 3, 2016

Last Update Submit

August 29, 2016

Conditions

Kidney Failure, ChronicEnd-Stage Renal Disease

Keywords

Kidney TransplantationLow Glycemic IndexHigh Protein

Outcome Measures

Primary Outcomes (1)

  • Weight Change

    Digital Balance

    Baseline, 1st month, 2nd month, 3rd month, 4th month, 5th month, 6th month, 9th month and 12th month.

Secondary Outcomes (7)

  • Body Composition Change

    Baseline, 3rd month, 6th month, 9th month and 12th month.

  • Basal Metabolic Rate

    Baseline and 6th month.

  • Satiety

    Baseline, 3rd month, 6th month, 9th month and 12th month for intervention group and at baseline for control group.

  • Kidney function

    12 months

  • Glycated hemoglobin

    Baseline, 3rd month, 6th month, 9th month and 12th month.

  • +2 more secondary outcomes

Study Arms (2)

High Protein and Low Glycemic Index Diet

EXPERIMENTAL

A protocol of a high protein and low glycemic index diet.

Behavioral: High Protein and Low Glycemic Index Diet

Conventional Diet

ACTIVE COMPARATOR

A protocol of a conventional diet.

Behavioral: Conventional Diet

Interventions

High Protein and Low Glycemic Index DietBEHAVIORAL

It will be evaluated a type of high protein diet with 1,3g/kg/day in kidney transplant recipients over 1 year after transplantation.

High Protein and Low Glycemic Index Diet
Conventional DietBEHAVIORAL

Conventional diet over 1 year after transplantation.

Conventional Diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney transplant recipients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (2)

  • Pedrollo EF, Correa C, Nicoletto BB, de Melo Cardoso de Freitas J, Buboltz JR, da Costa BDF, Dos Santos Guedes G, Bauer AC, Manfro RC, Souza GC, Leitao CB. Effect of an intensive nutrition intervention of a high protein and low glycemic load diet on weight of kidney transplant recipients: a randomized clinical trial. Endocrine. 2025 Jan;87(1):106-115. doi: 10.1007/s12020-024-03978-y. Epub 2024 Aug 5.

    PMID: 39102111DERIVED

  • Pedrollo EF, Nicoletto BB, Carpes LS, de Freitas JMC, Buboltz JR, Forte CC, Bauer AC, Manfro RC, Souza GC, Leitao CB. 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. Trials. 2017 Sep 6;18(1):413. doi: 10.1186/s13063-017-2158-2.

    PMID: 28874181DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elis Forcellini Pedrollo, Master

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 30, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

BR(1)