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Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02917278
Enrollment
19
Registered
2016-09-28
Start date
2016-02-29
Completion date
2016-05-31
Last updated
2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease, Hemodialysis, Meals

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.

Interventions

DIETARY_SUPPLEMENTMeals

High Protein renal-specific meals

Sponsors

Purdue University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Hypotensive Event Frequency9 weeksfrequency of hypotensive events that require intervention during dialysis

Secondary

MeasureTime frameDescription
Mean Arterial Pressure (mm Hg)9 weeksAverage Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study.
Serum Albumin9 weeks—
Blood Urea Nitrogen9 weeks—
Serum Creatinine9 weeks—
Blood Glucose9 weeks—
Serum Adjusted Calcium9 weeks—
Serum Sodium9 weeks—
Hunger Rating9 weeksHunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome.
Serum Chloride9 weeks—
Serum CO29 weeks—
Serum Pre-albumin9 weeks—
Dialysis Absences9 weeksAbsences out of 25 sessions
Interdialytic Weight Gain9 weeks—
Vitality Score9 weeksVitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Sleep Problems Index9 weeksSleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
Serum Phosphate9 weeks—

Countries

United States

Participant flow

Participants by arm

ArmCount
Meals
High-protein renal-specific meals Meals: High Protein renal-specific meals
9
Control
No Meals
9
Total18

Baseline characteristics

CharacteristicMealsControlTotal
Age, Continuous66.8 years
STANDARD_DEVIATION 11.4
58.1 years
STANDARD_DEVIATION 19.2
62.4 years
STANDARD_DEVIATION 15.9
Body Mass Index, kg/m^234.2 kg/m^2
STANDARD_DEVIATION 10.2
31.1 kg/m^2
STANDARD_DEVIATION 8
32.6 kg/m^2
STANDARD_DEVIATION 9
Race and Ethnicity Not Collected——0 Participants
Region of Enrollment
United States
9 participants9 participants18 participants
Sex: Female, Male
Female
5 Participants5 Participants10 Participants
Sex: Female, Male
Male
4 Participants4 Participants8 Participants
Years on Dialysis3.1 years
STANDARD_DEVIATION 2
3.6 years
STANDARD_DEVIATION 3.3
3.3 years
STANDARD_DEVIATION 2.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 90 / 9
serious
Total, serious adverse events
0 / 90 / 9

Outcome results

Primary

Hypotensive Event Frequency

frequency of hypotensive events that require intervention during dialysis

Time frame: 9 weeks

ArmMeasureValue (NUMBER)
MealsHypotensive Event Frequency18 events
ControlHypotensive Event Frequency13 events
Secondary

Blood Glucose

Time frame: 9 weeks

Population: Only measured in patients with diabetes mellitus

ArmMeasureValue (MEAN)Dispersion
MealsBlood Glucose137 mg/dLStandard Deviation 55
ControlBlood Glucose178 mg/dLStandard Deviation 77
Secondary

Blood Urea Nitrogen

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsBlood Urea Nitrogen49 mg/dLStandard Deviation 16
ControlBlood Urea Nitrogen59 mg/dLStandard Deviation 13
Secondary

Dialysis Absences

Absences out of 25 sessions

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsDialysis Absences0.9 absencesStandard Deviation 1.1
ControlDialysis Absences1.8 absencesStandard Deviation 2.6
Secondary

Hunger Rating

Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome.

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsHunger Rating1.01 units on a scaleStandard Deviation 1.01
ControlHunger Rating3.20 units on a scaleStandard Deviation 1.89
Secondary

Interdialytic Weight Gain

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsInterdialytic Weight Gain1.8 kgStandard Deviation 1.1
ControlInterdialytic Weight Gain2.4 kgStandard Deviation 2.1
Secondary

Mean Arterial Pressure (mm Hg)

Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study.

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsMean Arterial Pressure (mm Hg)75 mm HgStandard Deviation 8
ControlMean Arterial Pressure (mm Hg)84 mm HgStandard Deviation 11
Secondary

Serum Adjusted Calcium

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsSerum Adjusted Calcium9.3 mg/dLStandard Deviation 0.4
ControlSerum Adjusted Calcium9.3 mg/dLStandard Deviation 0.6
Secondary

Serum Albumin

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsSerum Albumin3.7 g/dLStandard Deviation 0.3
ControlSerum Albumin3.8 g/dLStandard Deviation 0.3
Secondary

Serum Chloride

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsSerum Chloride100 mEq/LStandard Deviation 2
ControlSerum Chloride98 mEq/LStandard Deviation 3
Secondary

Serum CO2

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsSerum CO225 mEq/LStandard Deviation 1
ControlSerum CO225 mEq/LStandard Deviation 2
Secondary

Serum Creatinine

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsSerum Creatinine6.8 mg/dLStandard Deviation 1.1
ControlSerum Creatinine7.8 mg/dLStandard Deviation 4.4
Secondary

Serum Phosphate

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsSerum Phosphate5.2 mg/dLStandard Deviation 0.7
ControlSerum Phosphate7.0 mg/dLStandard Deviation 1.7
Secondary

Serum Pre-albumin

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsSerum Pre-albumin26 mg/dLStandard Deviation 7
ControlSerum Pre-albumin26 mg/dLStandard Deviation 8
Secondary

Serum Sodium

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsSerum Sodium138 mEq/LStandard Deviation 2
ControlSerum Sodium137 mEq/LStandard Deviation 3
Secondary

Sleep Problems Index

Sleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsSleep Problems Index49.04 score on a scaleStandard Deviation 10.2
ControlSleep Problems Index43.37 score on a scaleStandard Deviation 13
Secondary

Vitality Score

Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
MealsVitality Score42.94 score on a scaleStandard Deviation 18.3
ControlVitality Score42.04 score on a scaleStandard Deviation 11.99

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026