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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000050560

Enrollment

100

Registered

2023-03-10

Start date

2023-03-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

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 wh

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
HbA1c (after 6 months)	—

Secondary

Measure	Time frame
(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	—

Countries

Japan

Contacts

Public ContactTakatoshi Kato

Hokuyo University Faculty of International Cultural Studies, Department of Career Creation

t_kato@hokuyo.ac.jp050-3717-9209

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026