End Stage Renal DiseaseNCT00597025
Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
A study testing Protein Food Bar Intelligent Indulgence in people with End Stage Renal Disease and Hypoalbuminemia, run by Satellite Healthcare at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Hypoalbuminemia, Malnutrition
- What is being tested?
- Protein Food Bar Intelligent Indulgence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days.
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Satellite Healthcare, Inc.
Mountain View, California, 94041
WellBound, Inc.
Mountain View, California, 94041
About this study
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.
- Conditions
- End Stage Renal Disease, Hypoalbuminemia, Malnutrition
- Being tested
- Protein Food Bar Intelligent Indulgence
- Keywords
- Malnutrition, Hypoalbuminemia, Dietary Supplements, Hemodialysis, Peritoneal Dialysis
- Medical subject headings
- Kidney Failure, Chronic, Hypoalbuminemia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein Food Bar Intelligent IndulgenceDietary supplement
Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months
Protein Food Bar Intelligent IndulgenceDietary supplement
Patients will be given 7 bars per week. In addition to the the three bars given on Hemodialysis each week, the patients will be given on the first treatment of the week four protein bars to be eaten on non-dialysis days
Protein Food Bar Intelligent IndulgenceDietary supplement
Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Center Hemodialysis patients Receives: Dietary Supplement: Protein Food Bar Intelligent Indulgence |
| Group B | Active comparator | Center hemodialysis patients Receives: Dietary Supplement: Protein Food Bar Intelligent Indulgence |
| Group C | No intervention | Center Hemodialysis Patients |
| Group D | Active comparator | Peritoneal dialysis patients Receives: Dietary Supplement: Protein Food Bar Intelligent Indulgence |
| Group E | No intervention | Peritoneal dialysis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Each month for 3 months
Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored
Measured: Each month for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Schiller-Moran, MD, Principal investigator, Satellite Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597025
- Sponsor's protocol ID
- SR017PB
- Status last verified
- Apr 2019
- First submitted
- 8 Jan 2008
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
- ClinicalTrials.gov ID
- NCT00597025
- Acronym / sponsor ID
- SR017PB
- Conditions
- End Stage Renal Disease, Hypoalbuminemia, Malnutrition
- Keywords
- Malnutrition, Hypoalbuminemia, Dietary Supplements, Hemodialysis, Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- Dec 2007 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Dietary Supplement: Protein Food Bar Intelligent IndulgenceCenter Hemodialysis patients |
| Group B | Active comparator | Dietary Supplement: Protein Food Bar Intelligent IndulgenceCenter hemodialysis patients |
| Group C | No intervention | –Center Hemodialysis Patients |
| Group D | Active comparator | Dietary Supplement: Protein Food Bar Intelligent IndulgencePeritoneal dialysis patients |
| Group E | No intervention | –Peritoneal dialysis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days.
- 18 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein Food Bar Intelligent IndulgencePatients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months | Dietary supplement | Group A |
| Protein Food Bar Intelligent IndulgencePatients will be given 7 bars per week. In addition to the the three bars given on Hemodialysis each week, the patients will be given on the first treatment of the week four protein bars to be eaten on non-dialysis days | Dietary supplement | Group B |
| Protein Food Bar Intelligent IndulgencePatients will be given a monthly supply of protein bars to provide for daily intake of one protein bar. | Dietary supplement | Group D |
Primary outcome
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.
Time frame: 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.
Time frame: Each month for 3 months
3 secondary outcomes
Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period
Time frame: 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.
Time frame: Each month for 3 months
Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored
Time frame: Each month for 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Schiller-Moran, MD principal investigator
Satellite Healthcare, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein Food Bar Intelligent Indulgence in people with End Stage Renal Disease and Hypoalbuminemia, run by Satellite Healthcare at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Each month for the three months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.