Evidence map›Paper›PMID 41286680›Full record

ArticleBMC nephrology2025

Design and rationale for a pilot trial of D-alanine supplementation to reduce the triglyceride to high-density lipoprotein cholesterol ratio in patients with chronic kidney disease.

Masaru Matsui, Masatoshi Nishimoto, Takayuki Uemura, Shunsuke Kitamura, Wasako Tato, Hideo Tsushima, Takaaki Kosugi, Masahiro Eriguchi, Ken-Ichi Samejima, Masashi Mita and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC nephrology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Masaru MatsuiDepartment of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan. matsui2008420@gmail.com.
Masatoshi NishimotoDepartment of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan.
Takayuki UemuraDepartment of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan.
Shunsuke KitamuraDepartment of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan.
Wasako TatoDepartment of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan.
Hideo TsushimaDepartment of Nephrology, Nara Prefecture General Medical Center, 897-5 Shichijo-nishimachi, Nara, 630-8581, Japan.
Takaaki KosugiDepartment of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan.
Masahiro EriguchiDepartment of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan.
Ken-Ichi SamejimaDepartment of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan.
Masashi MitaKagami Inc., 7-7-15 Saito-asagi, Ibaraki, Osaka, 567-0085, Japan.
Masato KasaharaInstitute for Clinical and Translational Science, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan.
Kazuhiko TsuruyaDepartment of Nephrology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan.

Funding

the Clinical Research Promotion Grant Program of Nara Medical University JHR2400002
6 · The paper itself

Abstract

backgroundChronic kidney disease (CKD) is an increasingly prevalent disease that adversely affects patients' quality of life and medical expenses. While its progression is linked to lifestyle-related diseases, its association with dyslipidemia remains unclear. We previously showed a significant association between a high triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio and CKD progression and cardiovascular disease in CKD patients. Recent reports indicate that D-alanine regulates circadian rhythms, participates in gluconeogenesis, and exhibits renoprotective effects. This study will investigate whether D-alanine has a beneficial effect on the TG/HDL-C ratio in CKD patients.

methodsThis open-label, multicenter, single-arm, exploratory trial will involve 20 CKD patients and last for 10 weeks, including a 2-week run-in, 4-week treatment, and 4-week follow-up period. Patients will be recruited from Nara Medical University and Nara Prefectural General Medical Center. The primary endpoint is the change in fasting TG/HDL-C ratios between baseline and Day 28. Secondary endpoints include changes in fasting TG, HDL-C, low-density lipoprotein cholesterol, aspartate aminotransferase, alanine aminotransferase, glycated hemoglobin A1c, systolic and diastolic blood pressure, proteinuria, estimated glomerular filtration rate, and body weight between baseline and Day 28. The study will summarize absolute measurements and changes using descriptive statistics, confidence intervals, and line graphs showing means ± confidence intervals. A two-tailed significance level of p < 0.05 will be used. DISCUSSION: This exploratory study aims to evaluate the efficacy and safety of D-alanine for treating dyslipidemia in CKD patients, and may provide insights that help reduce the risk of cardiorenal events in CKD patients.

trial registrationThis protocol was approved by the Clinical Trial Review Board of Nara Medical University Clinical Research Review Committee (CRB5200002) on February 5, 2025, and is available to the public on the website of the Japan Registry of Clinical Trials on December 18, 2024 (jRCTs051240262).

Indexed as

AlanineCholesterol, HDLDietary SupplementsDyslipidemiasRenal Insufficiency, ChronicTriglyceridesAdultAgedFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPilot ProjectsAlanineCholesterol, HDLTriglyceridesD-alanineHigh-density lipoprotein cholesterolTriglyceride

Identifiers

PMID41286680
PMCPMC12750682

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.