UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050560
Receipt number R000057573
Scientific Title The efficacy of a healthy gut microbiome-based diet tool versus a conventional diet tool for patients with Type 2 diabetes : A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial
Date of disclosure of the study information 2023/03/10
Last modified on 2025/03/28 10:35:30

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Basic information

Public title

The efficacy of a healthy gut microbiome-based diet tool versus a conventional diet tool for patients with Type 2 diabetes : A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial

Acronym

A comparative trial of healthy gut microbiota-based and conventional diet tool for patients with Type 2 diabetes

Scientific Title

The efficacy of a healthy gut microbiome-based diet tool versus a conventional diet tool for patients with Type 2 diabetes : A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial

Scientific Title:Acronym

A comparative trial of healthy gut microbiota-based and conventional diet tool for patients with Type 2 diabetes

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to develop a "diet therapy tool" for patients with type 2 diabetes, which is explored from the analysis of healthy gut microbiota.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HbA1c (after 6 months)

Key secondary outcomes

(after 1,3,6,12 months)
1)Diet
2)HbA1c
3)Diabetes Mellitus Dietary Self Efficacy Scale : DMDSES
4)Diabetes treatment satisfaction questionnaire : DTSQ
5)Scale of Dietary Distress in Patients with Type 2 Diabetes


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Diet therapy tool based on healthy gut microbiota (Dietary menu book)
(If the subject reviewed the content of this document, and if the attending physician reviewed, it may be possible to identify which group the subject belongs to. Because this study is a double-blind study designed to prevent physicians from deciding between intervention and placebo groups, details of this tool cannot be disclosed on this from until the study is completed.)

Interventions/Control_2

Conventional diet therapy tool (Dietary menu book) (placebo tool)
(If the subject reviewed the content of this document, and if the attending physician reviewed, it may be possible to identify which group the subject belongs to. Because this study is a double-blind study designed to prevent physicians from deciding between intervention and placebo groups, details of this tool cannot be disclosed on this from until the study is completed.)

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with type 2 diabetes with an HbA1c value of 7.0% or more and 8.9% or less at the start of this survey
(However, if the number of applicants cannot be secured, the HbA1c value shall be 6.5% or more and 8.9% or less.)
2)

Key exclusion criteria

1)Patients with nephropathy-specific dietary restrictions of protein and potassium
(However, if the attending physician approves, it is possible to conduct this research.)
2)Patients who find it difficult to conduct questionnaire surveys due to dementia, mental illness, etc

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Takatoshi
Middle name
Last name Kato

Organization

Hokkaido University

Division name

Office of Diversity, Equity, and Inclusion

Zip code

060-0812

Address

Kita 12, Nishi 7, Kita-ku, Sapporo Hokkaido 060-0812, JAPAN

TEL

011-706-3625

Email

kato@dei.hokudai.ac.jp


Public contact

Name of contact person

1st name Takatoshi
Middle name
Last name Kato

Organization

Hokkaido University

Division name

Office of Diversity, Equity, and Inclusion

Zip code

060-0812

Address

Kita 12, Nishi 7, Kita-ku, Sapporo Hokkaido 060-0812, JAPAN

TEL

050-3717-9209

Homepage URL


Email

kato@dei.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University

Institute

Department

Personal name

Takatoshi Kato


Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sapporo University of Health Sciences Research Ethics Committee

Address

4-2-1-15 Nakanuma-nishi, Higashi-ku, Sapporo, Hokkaido 007-0894, JAPAN

Tel

011-792-3350

Email

somu@sapporo-hokeniryou-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2023 Year 03 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2023 Year 01 Month 13 Day

Date of IRB

2023 Year 01 Month 19 Day

Anticipated trial start date

2023 Year 03 Month 11 Day

Last follow-up date

2024 Year 10 Month 11 Day

Date of closure to data entry

2026 Year 03 Month 11 Day

Date trial data considered complete

2026 Year 03 Month 11 Day

Date analysis concluded

2026 Year 03 Month 11 Day


Other

Other related information



Management information

Registered date

2023 Year 03 Month 10 Day

Last modified on

2025 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057573