NCT02917278

Brief Summary

This pilot study aims to produce preliminary data on the safety of providing high-protein meals to patients during dialysis, and effects of this intervention on nutritional status and quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of daily recommended protein intake. Patients will be allocated to either the treatment or control group by HD shift schedule. 2 months of baseline data will be collected, followed by 9 weeks of meal intervention/control and data collection. The primary outcome will be frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes will include highest and lowest systolic blood pressure during dialysis, blood biochemistries including measures of renal function, nutritional status, and electrolyte balance; dialysis compliance; fluid retention; sleep and other quality of life measures; and dietary intake data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

May 18, 2021

Completed
Last Updated

October 19, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 26, 2016

Results QC Date

August 31, 2020

Last Update Submit

September 23, 2021

Conditions

End-Stage Renal DiseaseMealsHemodialysis

Outcome Measures

Primary Outcomes (1)

  • Hypotensive Event Frequency

    frequency of hypotensive events that require intervention during dialysis

    9 weeks

Secondary Outcomes (16)

  • Mean Arterial Pressure (mm Hg)

    9 weeks

  • Serum Albumin

    9 weeks

  • Blood Urea Nitrogen

    9 weeks

  • Serum Creatinine

    9 weeks

  • Blood Glucose

    9 weeks

  • +11 more secondary outcomes

Study Arms (2)

Meals

EXPERIMENTAL

High-protein renal-specific meals

Dietary Supplement: Meals

Control

NO INTERVENTION

No Meals

Interventions

MealsDIETARY_SUPPLEMENT

High Protein renal-specific meals

Meals

Eligibility Criteria

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

You may qualify if:

  • Men and women
  • Any race
  • Age 18 years or older
  • Maintenance hemodialysis patients

You may not qualify if:

  • Patients with dysphagia that cannot be accommodated by texture modifications, or those exclusively NPO/requiring tube feeding or parenteral feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • Choi MS, Kistler B, Wiese GN, Stremke ER, Wright AJ, Moorthi RN, Moe SM, Hill Gallant KM. Pilot Study of the Effects of High-Protein Meals During Hemodialysis on Intradialytic Hypotension in Patients Undergoing Maintenance Hemodialysis. J Ren Nutr. 2019 Mar;29(2):102-111. doi: 10.1053/j.jrn.2018.06.002. Epub 2018 Aug 11.

    PMID: 30107974RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Meals

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

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Kathleen Hill Gallant
Organization
Purdue University
hillgallant@purdue.edu
765-494-0101

Study Officials

  • Kathleen M Hill Gallant, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor nutrition science

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 28, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 19, 2021

Results First Posted

May 18, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

De-identified individual participate data is available to other researchers upon reasonable request.

Available IPD Datasets

Meeting abstract Access

Locations

US(1)