NCT00597025

Brief Summary

This study is to evaluate the impact of providing high protein supplementation in the form of a medical food bar containing 20grams of protein eath to hypoalbuminemic dialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
375

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 20, 2020

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

January 8, 2008

Last Update Submit

March 18, 2020

Conditions

End Stage Renal DiseaseHypoalbuminemiaMalnutrition

Keywords

MalnutritionHypoalbuminemiaDietary SupplementsHemodialysisPeritoneal Dialysis

Outcome Measures

Primary Outcomes (2)

  • The mean change (from baseline to month 3) in serum albumin levels among study groups and the proportion of patients treated with the protein food bar reaching an increase of 0.3 g/dL over the three month study period.

    Each month for the three months.

  • Incidence of potential adverse events including nausea, vomiting, diarrhea, acidosis, and uremic symptoms as evidenced by clinical symptoms and possible worsening of laboratory measures such as BUN, Kt/V, nPNA and bicarbonate.

    Each month for 3 months

Secondary Outcomes (3)

  • Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period

    Month 3

  • Overall acceptance and compliance of bar form medical food over a 3 month period will be assessed via the proportion of patients who ingested 75% or more of the recommended bars.

    Each month for 3 months

  • Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored

    Each month for 3 months

Study Arms (5)

Group A

ACTIVE COMPARATOR

Center Hemodialysis patients

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Group B

ACTIVE COMPARATOR

Center hemodialysis patients

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Group C

NO INTERVENTION

Center Hemodialysis Patients

Group D

ACTIVE COMPARATOR

Peritoneal dialysis patients

Dietary Supplement: Protein Food Bar Intelligent Indulgence

Group E

NO INTERVENTION

Peritoneal dialysis patients

Interventions

Protein Food Bar Intelligent IndulgenceDIETARY_SUPPLEMENT

Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months

Group A

Eligibility Criteria

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

You may qualify if:

  • Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days.
  • years of age or older.
  • Must have a reasonable expectation of remaining on treatment for at least 3 months.
  • Must have an average serum albumin of \<3.5 g/dL over the three months prior to entry into the study.
  • Must be able to understand and sign the informed consent.
  • Must be willing and able to participate in nutrition interviews for determination of nutrient intake from conventional foods.

You may not qualify if:

  • Allergy to protein, milk, nuts or wheat.
  • Documented ongoing acute infection or inflammatory process including treatment with antibiotics within a two week time of study entry.
  • Severe acidosis defined as pre-dialysis serum bicarbonate levels of \<15 mEq/L.
  • Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.
  • Hospitalization for an infectious condition within 4 weeks prior to study entry.
  • Planned surgery within the three month study period including planned kidney transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Satellite Healthcare, Inc.

Mountain View, California, 94041, United States

Location

WellBound, Inc.

Mountain View, California, 94041, United States

Location

MeSH Terms

Conditions

Kidney Failure, ChronicHypoalbuminemiaMalnutrition

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 SymptomsHypoproteinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Brigitte Schiller-Moran, MD

    Satellite Healthcare, Inc.

    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

January 8, 2008

First Posted

January 17, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 20, 2020

Record last verified: 2019-04

Locations

US(2)