Chronic Kidney FailureNCT01890811
Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
A study testing Boost High Protein in people with Chronic Kidney Failure, run by Texas A&M University at 1 site in United States.
Trial summary
Weight loss commonly occurs in patients with chronic kidney disease (CKD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CKD patients but patients also have reductions in fat mass and bone density, independent of… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- Boost High Protein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2016
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to walk, sit down and stand up independently
- Age 55 years or older
- Ability to lie in supine or elevated position for 7 hours
- Diagnosis of kidney disease; undergoing hemodialysis
- Clinically stable condition; no hospitalization 4 weeks preceding first study day
- Willingness and ability to comply with the protocol
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- Healthy male or female according to the investigator's or appointed staff's judgment
- Ability to walk, sit down and stand up independently
- Age 55 years or older (older control group)
- Ability to lay in supine or elevated position for 7 hours
- No diagnosis of CKD
- Willingness and ability to comply with the protocol
Who cannot join
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
- Established diagnosis of malignancy
- Established diagnosis of Insulin Dependent Diabetes Mellitus
- History of untreated metabolic diseases including hepatic disorder
- Presence of acute illness or metabolically unstable chronic illness
- Presence of fever within the last 3 days
Show all 12Show fewer
- Body mass index >40 kg/m2 (healthy subjects only)
- Any other condition that would interfere with the study or safety of the patient (according to the PI or nurse)
- Use of protein or amino acid containing nutritional supplements within 5 days of first study day
- Use of long-term oral corticosteroids or short course of oral corticosteroids within 4 weeks preceding first study day
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- (Possible) pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Weight loss commonly occurs in patients with chronic kidney disease (CKD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CKD patients but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. Attempts to reverse weight and muscle loss in CKD and improve nutritional status by nutritional supplementation have been unsuccessful and there are currently no approved therapies.
Purpose of this study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CKD patients compared to matched healthy controls. Additionally, to examine whether protein and amino acid metabolism is disturbed in CKD patients compared to healthy controls. This will provide required information that will lead to implement new strategies to develop optimal nutritional regimen in order to enhance nutritional status, quality of life and survival in relation to kidney disease.
Read the detailed description
This study involves one test day of approximately 7-8 hours. On this test day subjects will ingest a sugar drink to assess gut permeability and gut function, and a protein meal to measure digestion/absorption and the anabolic response to food intake. Subjects will also receive a mixture of amino acids that are made a little heavier than normal, called stable isotopes. This stable isotopes is used to investigate protein behavior in the body (protein kinetics). Blood (100-120 ml in total) and urine samples will be collected over 7.5 hours.
- Conditions
- Chronic Kidney Failure
- Being tested
- Boost High Protein
- Keywords
- CKD, Hemodialysis, Protein Digestion, Fat Digestion, Gut Function, Glucose Absorption, Muscle Function
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boost High ProteinDietary supplement
Subjects will receive stable amino acid isotopes IV and will receive Boost High Protein with added isotopes to measure anabolic response to a meal.
| Study group | Role | What they receive |
|---|---|---|
| Boost High Protein | Experimental | Boost high protein with added spirulina Receives: Dietary Supplement: Boost High Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net whole-body protein synthesis
Change in whole-body protein synthesis rate after intake of meal
Measured: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
Secondary outcomes (15)
Citrulline Rate of appearance
Plasma enrichment of citrulline
Measured: Postabsorptive state during 3 hours
Glucose absorption
Recovery of 3-O-Methyl-D-glucose in the urine.
Measured: 7 hours
Gut permeability
Recovery of rhamnose/lactulose in urine
Measured: 7 hours
Skeletal and respiratory muscle strength
Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.
Measured: 1 day
Cognitive function
Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism
Measured: 1 day
Fatty acid digestion after feeding
Enrichment in palmitic acid and tripalmitin fatty acids in plasma
Measured: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
Protein digestion after feeding
Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina
Measured: 0,15,30,45,60,75,90,105,120,150,180,210, min post-meal
Arginine turnover rate
Arginine enrichment in plasma
Measured: Postabsorptive state during 3 hours
Whole body collagen breakdown rate
Hydroxyproline enrichment in plasma
Measured: Postabsorptive state during 3 hours
Tryptophan turnover rate
Tryptophan enrichment in plasma
Measured: Postabsorptive state during 3 hours
Insulin response to feeding
Acute change from postabsorptive state after intake of meal
Measured: During 3 hours after feeding
Fat-free mass
Characteristics of study subjects
Measured: Postabsorptive state during 15 min
Myofibrillar protein breakdown rate
3-Methylhistidine enrichment in plasma
Measured: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
Glycine rate of appearance
Glycine enrichment in plasma
Measured: Postabsorptive state during 3 hours
Taurine turnover rate
Enrichment of taurine in plasma
Measured: Postabsorptive state during 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890811
- Sponsor's protocol ID
- 2013-0294
- Status last verified
- Apr 2015
- First submitted
- 27 Jun 2013
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
- ClinicalTrials.gov ID
- NCT01890811
- Acronym / sponsor ID
- 2013-0294
- Conditions
- Chronic Kidney Failure
- Keywords
- CKD, Hemodialysis, Protein Digestion, Fat Digestion, Gut Function, Glucose Absorption, Muscle Function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Jul 2013 (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.
Weight loss commonly occurs in patients with chronic kidney disease (CKD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CKD patients but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. Attempts to reverse weight and muscle loss in CKD and improve nutritional status by nutritional supplementation have been unsuccessful and there are currently no approved therapies.
Purpose of this study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CKD patients compared to matched healthy controls. Additionally, to examine whether protein and amino acid metabolism is disturbed in CKD patients compared to healthy controls. This will provide required information that will lead to implement new strategies to develop optimal nutritional regimen in order to enhance nutritional status, quality of life and survival in relation to kidney disease.
Detailed description
This study involves one test day of approximately 7-8 hours. On this test day subjects will ingest a sugar drink to assess gut permeability and gut function, and a protein meal to measure digestion/absorption and the anabolic response to food intake. Subjects will also receive a mixture of amino acids that are made a little heavier than normal, called stable isotopes. This stable isotopes is used to investigate protein behavior in the body (protein kinetics). Blood (100-120 ml in total) and urine samples will be collected over 7.5 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boost High Protein | Experimental | Dietary Supplement: Boost High ProteinBoost high protein with added spirulina |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability to walk, sit down and stand up independently
- Age 55 years or older
- Ability to lie in supine or elevated position for 7 hours
- Diagnosis of kidney disease; undergoing hemodialysis
- Clinically stable condition; no hospitalization 4 weeks preceding first study day
Key exclusion criteria (12 listed)
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
- Established diagnosis of malignancy
- Established diagnosis of Insulin Dependent Diabetes Mellitus
- History of untreated metabolic diseases including hepatic disorder
- Presence of acute illness or metabolically unstable chronic illness
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 |
|---|---|---|
| Boost High ProteinSubjects will receive stable amino acid isotopes IV and will receive Boost High Protein with added isotopes to measure anabolic response to a meal. | Dietary supplement | Boost High Protein |
Primary outcome
Net whole-body protein synthesis
Time frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
Change in whole-body protein synthesis rate after intake of meal
15 secondary outcomes
Citrulline Rate of appearance
Time frame: Postabsorptive state during 3 hours
Glucose absorption
Time frame: 7 hours
Gut permeability
Time frame: 7 hours
Skeletal and respiratory muscle strength
Time frame: 1 day
Cognitive function
Time frame: 1 day
Fatty acid digestion after feeding
Time frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
Protein digestion after feeding
Time frame: 0,15,30,45,60,75,90,105,120,150,180,210, min post-meal
Arginine turnover rate
Time frame: Postabsorptive state during 3 hours
Whole body collagen breakdown rate
Time frame: Postabsorptive state during 3 hours
Tryptophan turnover rate
Time frame: Postabsorptive state during 3 hours
Insulin response to feeding
Time frame: During 3 hours after feeding
Fat-free mass
Time frame: Postabsorptive state during 15 min
Myofibrillar protein breakdown rate
Time frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
Glycine rate of appearance
Time frame: Postabsorptive state during 3 hours
Taurine turnover rate
Time frame: Postabsorptive state during 3 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boost High Protein in people with Chronic Kidney Failure, run by Texas A&M University at 1 site 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 12 inclusion and 12 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: withdrawn, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Net whole-body protein synthesis (time frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal). 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 1 May 2015.