Evidence map›Paper›PMID 38340247›Full record

ArticleClinical and experimental nephrology2024

Design and rationale for an open-label, randomized, controlled pilot trial to evaluate the changes in blood uremic toxins in patients with chronic kidney disease by dietary therapy with sake lees.

Toshiaki Tokumaru, Tadashi Toyama, Yusuke Nakade, Hisayuki Ogura, Megumi Oshima, Shiori Nakagawa, Motoe Furuichi, Shinji Kitajima, Norihiko Sakai, Miho Shimizu and 2 more

Open access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and experimental nephrology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 35% of its field
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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
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 at 2 institutions in 1 country.

Toshiaki TokumaruDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan.
Tadashi ToyamaDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan. t-toyama@staff.kanazawa-u.ac.jp.
Yusuke NakadeDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan.
Hisayuki OguraDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan.
Megumi OshimaDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan.
Shiori NakagawaDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan.
Motoe FuruichiDepartment of Nutrition Management, Kanazawa University Hospital, Kanazawa, Japan.
Shinji KitajimaDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan.
Norihiko SakaiDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan.
Miho ShimizuDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan.
Yasunori IwataDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan.
Takashi WadaDepartment of Nephrology and Rheumatology, Kanazawa University, Takara-Machi 13-1, Kanazawa City, Ishikawa, 920-8641, Japan.
Kanazawa University · JPKanazawa University Hospital · JP

Funding

Japan Agency for Medical Research and Development JP21lk0310074
6 · The paper itself

Abstract

backgroundPatients with chronic kidney disease (CKD) reportedly show dysbiosis, which is the imbalance of gut microbiome. Dysbiosis increases the uremic toxin level in the intestine, and uremic toxins transfer into the blood, causing CKD progression. Sake lees, a traditional Japanese fermented food, may help reduce uremic toxins by altering the gut microbiome. Additionally, D-alanine, which is present in sake lees, may have a renoprotective effect. The present pilot study aims to evaluate the effect of adding sake lees to the standard CKD dietary therapy in reducing blood uremic toxins.

methodsThis pilot study is a single-center, open-label, randomized controlled trial. Twenty-four patients with CKD will be enrolled and allocated 1:1 to the intervention and control groups. The intervention group will receive standard CKD dietary therapy with an additional intake of 50 g of sake lees per day for 8 weeks, whereas the control group will only receive standard CKD dietary therapy. The primary endpoint is the change in serum indoxyl sulfate after 8 weeks. The secondary endpoint is the plasma D-alanine and fecal microbiome changes.

conclusionThis pilot study provides insight into the development of a new diet focused on gut microbiome and D-amino acids in patients with CKD. CLINICAL

trial registrationThis protocol was approved by the Clinical Trial Review Board of Kanazawa University Hospital on October 27, 2022 (2022-001 [6139]) and available to the public on the website of the Japan Registry of Clinical Trials on November 22, 2022 (jRCT1040220095).

Indexed as

Gastrointestinal MicrobiomeRenal Insufficiency, ChronicUremic ToxinsAdultAgedDysbiosisFemaleFermented FoodsHumansMaleMiddle AgedPilot ProjectsRandomized Controlled Trials as TopicUremic ToxinsChronic kidney diseaseD-amino acidsDysbiosisSake leesUremic toxins

Identifiers

PMID38340247
PMCPMC11033224
OpenAlexW4391723841

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LicenceCC BY
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Registered trials

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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 OpenQuestion graph.