UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062428 |
|---|---|
| Receipt number | R000071413 |
| Scientific Title | An interventional study of the usefulness of manual therapy, including Seitai, as part of a dietary program aimed at reducing visceral fat: an open-label, randomized, parallel-group controlled trial |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/07/31 16:29:02 |
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Basic information
Public title
A study of whether adding manual therapy, including Seitai, to a dietary program helps reduce visceral fat
Acronym
SEITAI Diet Study
Scientific Title
An interventional study of the usefulness of manual therapy, including Seitai, as part of a dietary program aimed at reducing visceral fat: an open-label, randomized, parallel-group controlled trial
Scientific Title:Acronym
SEITAI-VF Trial
Region
| Japan |
Condition
Condition
Obesity (BMI 25 or higher) and/or abdominal obesity (visceral fat accumulation) in adults seeking weight reduction
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In adults seeking weight reduction (BMI 25 or higher, or waist circumference 85 cm or more for men and 90 cm or more for women), this study evaluates the usefulness of adding manual therapy such as Seitai to a diet program (intervention group) compared with the diet program alone (control group), using an open-label, randomized, parallel-group design with partial assessor blinding. The primary endpoint is the change or percent change in waist circumference from week 0 to week 12. Secondary endpoints include changes in anthropometric measures (body weight, BMI, body fat percentage), blood pressure, blood test values (glucose, HbA1c, serum lipids), constipation symptoms (CAS), health-related quality of life (SF-36v2 Japanese version), and habitual physical activity (IPAQ Japanese version), in order to assess holistic effects including pain, function, and exercise adherence. This study is positioned as an exploratory study examining the add-on effect of manual therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change and percent change in waist circumference from week 0 to week 12, measured in accordance with the JASSO guidelines
Key secondary outcomes
All outcomes are assessed as change or percent change from week 0 to week 12.
1. Anthropometric measures including body weight, BMI, and body fat percentage
2. Blood pressure (systolic and diastolic)
3. Blood test values (glucose, HbA1c, and serum lipids)
4. Constipation Assessment Scale (CAS, Japanese version): index of constipation symptoms
5. SF-36v2 Japanese version, standard form: index of health-related quality of life
6. International Physical Activity Questionnaire (IPAQ, Japanese short version, last 7 days): index of habitual physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Intervention group: a 12-week diet program combined with manual therapy such as Seitai (target 25 participants).
1. Diet program: nutritional guidance on dietary balance is provided once a week by a registered dietitian or specifically trained staff, including confirmation of adherence to the program text.
2. Manual therapy: Seitai treatment aimed at adjusting whole-body musculoskeletal balance is performed once a week for 20 minutes per session, for a total of 12 sessions. Treatment is provided by qualified practitioners according to the standardized procedures defined in this study.
3. Assessment: anthropometric measurements (height, body weight, body fat percentage, waist circumference), blood pressure (systolic and diastolic), blood tests (glucose, HbA1c, serum lipids), CAS, SF-36 and IPAQ are measured at week 0 and week 12.
4. The final intervention and final assessment are performed 12 weeks and 0 days after the first intervention in principle, with a permissible window up to 12 weeks and 6 days.
Interventions/Control_2
Control group: the diet program alone for 12 weeks (target 25 participants).
1. Diet program: the same dietary guidance as the intervention group is provided for 12 weeks, without concomitant manual therapy.
2. Assessment: the same outcome measures as the intervention group are measured at week 0 and week 12.
3. After the end of the intervention period, participants receive a total of 12 sessions of the same manual therapy as the intervention group, at any frequency.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 18 years or older
2. Individuals who wish to reduce body weight
3. BMI of 25 or higher, or waist circumference of 85 cm or more for men and 90 cm or more for women
4. Individuals able to participate continuously throughout the intervention period
5. Individuals who have received a sufficient explanation of the purpose and content of the study and have provided consent
6. Individuals without orthopedic or internal medical disorders
(The presence of orthopedic or internal medical disorders is checked by trained staff using a screening checklist supervised by a physician who is a co-investigator, and a physician makes the final decision on eligibility.)
Key exclusion criteria
1. Individuals who have received instructions from their attending physician that would affect participation in this program
2. Women who are pregnant or breastfeeding
3. Individuals otherwise judged likely to have difficulty completing the program
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Koga |
Organization
Baumkuchen Works Inc.
Division name
Research Office
Zip code
840-0851
Address
2-4-44 Konohigashi, Saga-shi, Saga, Japan
TEL
+81-952-37-8167
seitai.naoya@gmail.com
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Koga |
Organization
Baumkuchen Works Inc.
Division name
Research Office
Zip code
840-0851
Address
2-4-44 Konohigashi, Saga-shi, Saga, Japan
TEL
+81-952-37-8167
Homepage URL
https://bmkchnwks.com/
seitai.naoya@gmail.com
Sponsor or person
Institute
Baumkuchen Works Inc.
Institute
Department
Personal name
Naoya Koga
Funding Source
Organization
Baumkuchen Works Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee on Health and Medical Research, Smile Body Network, Nonprofit Organization
Address
6-43-13-301 Kitayamata, Tsuzuki-ku, Yokohama-shi, Kanagawa, Japan
Tel
+81-45-591-9949
info@smile-body.net
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
佐賀リカバリング整体院大財院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 13 | Day |
Date trial data considered complete
| 2026 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 01 | Month | 29 | Day |
Other
Other related information
This study is conducted with the approval of the Ethics Committee on Health and Medical Research, Smile Body Network, Nonprofit Organization (reference number 2025-2, approved on February 26, 2026). A minor amendment (change of the blood test kit) was submitted in April 2026 and approved.
Regarding assessor blinding, measurements are performed by staff not involved in the intervention, and care is taken to ensure that information on the intervention is not conveyed at the time of measurement. Assessors are asked to record which group they believe each participant belongs to, and the accuracy of these guesses is reported at the time of analysis to make the implementation of assessor blinding transparent.
In addition, one participant out of every 10 enrolled (5 participants in total) undergoes duplicate measurement by two assessors, and inter-rater reliability (ICC) is calculated to verify the internal validity of the measurements. The values obtained by the first assessor are used for the primary analysis.
Management information
Registered date
| 2026 | Year | 07 | Month | 31 | Day |
Last modified on
| 2026 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071413
