Renal Insufficiency, ChronicNCT03397550
The Relationship Between Salt Restriction and Taste Sensitivity in Patients With Chronic Kidney Disease
An observational study of Renal Insufficiency, Chronic and Chronic Kidney Diseases, run by Peking University First Hospital at 1 site in China.
Trial summary
The compliance of salt restriction in patients with CKD may be associated with taste sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency, Chronic, Chronic Kidney Diseases
- What is being tested?
- salt restriction education
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2022to 1 May 2023
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: stage 3-5 CKD patients
Who may be able to join
- stage 3-5 CKD patients
- clinical stable
Who cannot join
- renal replacement therapy
- cancer
- systemic infection
- Alzheimer's disease
- acute cardiovascular events, active hepatitis
- all other study-obstructive conditions
Trial locations and contacts
1 site in 1 country.
About this study
The compliance of salt restriction in patients with CKD may be associated with taste sensitivity.
- Being tested
- salt restriction education
- Keywords
- taste threshold, salt restriction
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salt restriction educationOther
Salt intake target：<5g/d Method：the standard salt restriction education will be lasting for 10-15 minutes by oral explanation at baseline.
What is being measured
The primary outcome is the main question the study is designed to answer.
ratings of taste sensitivity assessed by the ISO method of investigating sensitivity of taste（ISO 3972:1991）
Taste sensitivity is measured by five taste solutions（salty、sour、bitter、sweet、umami). Every taste solution contains 8 different concentration. Detection , recognition and difference thresholds will be measured .Their definitions are as bellow.
Detection threshold：minimum value of sensory stimulus needed to give rise to a sensation. The sensation need not be identified.
Recognition threshold：minimum value of a sensory stimulus permitting identification of the sensation perceived.
Difference threshold：value of the smallest perceptible difference in the physical intensity of a stimulus.
Measured: up to 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start18 Jun 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 May 2023 (estimated)
Why it stopped: feasibility is being questioned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, Study director, Peking Universiy First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397550
- Sponsor's protocol ID
- pekingUFH-cn
- Status last verified
- Oct 2022
- First submitted
- 13 Dec 2017
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lynch KE, Lynch R, Curhan GC, Brunelli SM. Altered taste perception and nutritional status among hemodialysis patients. J Ren Nutr. 2013 Jul;23(4):288-295.e1. doi: 10.1053/j.jrn.2012.08.009. Epub 2012 Oct 6.
PubMed 23046735Kusaba T, Mori Y, Masami O, Hiroko N, Adachi T, Sugishita C, Sonomura K, Kimura T, Kishimoto N, Nakagawa H, Okigaki M, Hatta T, Matsubara H. Sodium restriction improves the gustatory threshold for salty taste in patients with chronic kidney disease. Kidney Int. 2009 Sep;76(6):638-43. doi: 10.1038/ki.2009.214. Epub 2009 Jun 10.
PubMed 19516246Middleton RA, Allman-Farinelli MA. Taste sensitivity is altered in patients with chronic renal failure receiving continuous ambulatory peritoneal dialysis. J Nutr. 1999 Jan;129(1):122-5. doi: 10.1093/jn/129.1.122.
PubMed 9915887McMahon EJ, Campbell KL, Bauer JD. Taste perception in kidney disease and relationship to dietary sodium intake. Appetite. 2014 Dec;83:236-241. doi: 10.1016/j.appet.2014.08.036. Epub 2014 Sep 2.
PubMed 25192896
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Salt Restriction and Taste Sensitivity in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03397550
- Acronym / sponsor ID
- pekingUFH-cn
- Keywords
- taste threshold, salt restriction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: feasibility is being questioned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 18 Jun 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 12 Jan 2018 (actual)
- 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.
The compliance of salt restriction in patients with CKD may be associated with taste sensitivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- stage 3-5 CKD patients
Key inclusion criteria (2 listed)
- stage 3-5 CKD patients
- clinical stable
Key exclusion criteria (6 listed)
- renal replacement therapy
- cancer
- systemic infection
- Alzheimer's disease
- acute cardiovascular events, active hepatitis
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 |
|---|---|---|
| salt restriction educationSalt intake target：<5g/d Method：the standard salt restriction education will be lasting for 10-15 minutes by oral explanation at baseline. | Other | – |
Primary outcome
ratings of taste sensitivity assessed by the ISO method of investigating sensitivity of taste（ISO 3972:1991）
Time frame: up to 12 weeks after intervention
Taste sensitivity is measured by five taste solutions（salty、sour、bitter、sweet、umami). Every taste solution contains 8 different concentration. Detection , recognition and difference thresholds will be measured .Their definitions are as bellow. Detection threshold：minimum value of sensory stimulus needed to give rise to a sensation. The sensation need not be identified. Recognition threshold：minimum value of a sensory stimulus permitting identification of the sensation perceived. Difference threshold：value of the smallest perceptible difference in the physical intensity of a stimulus.
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 12 Oct 2022.
- Results publication: PubMed 23046735Lynch KE, Lynch R, Curhan GC, Brunelli SM. Altered taste perception and nutritional status among hemodialysis patients. J Ren Nutr. 2013 Jul;23(4):288-295.e1. doi: 10.1053/j.jrn.2012.08.009. Epub 2012 Oct 6.
- Results publication: PubMed 19516246Kusaba T, Mori Y, Masami O, Hiroko N, Adachi T, Sugishita C, Sonomura K, Kimura T, Kishimoto N, Nakagawa H, Okigaki M, Hatta T, Matsubara H. Sodium restriction improves the gustatory threshold for salty taste in patients with chronic kidney disease. Kidney Int. 2009 Sep;76(6):638-43. doi: 10.1038/ki.2009.214. Epub 2009 Jun 10.
- Results publication: PubMed 9915887Middleton RA, Allman-Farinelli MA. Taste sensitivity is altered in patients with chronic renal failure receiving continuous ambulatory peritoneal dialysis. J Nutr. 1999 Jan;129(1):122-5. doi: 10.1093/jn/129.1.122.
- Results publication: PubMed 25192896McMahon EJ, Campbell KL, Bauer JD. Taste perception in kidney disease and relationship to dietary sodium intake. Appetite. 2014 Dec;83:236-241. doi: 10.1016/j.appet.2014.08.036. Epub 2014 Sep 2.
- Individual participant dataSharing planned: Undecided
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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.
Jie Dong study director
Peking Universiy First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, Chronic and Chronic Kidney Diseases, run by Peking University First Hospital at 1 site in China.
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 2 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: withdrawn, as of the sponsor's last update on 12 Oct 2022. 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 China. 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?
ratings of taste sensitivity assessed by the ISO method of investigating sensitivity of taste（ISO 3972:1991） (time frame: up to 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03397550, which also lists 4 linked publications.
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 12 Oct 2022.