Clinical Trial: 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 (Japan)

Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062428) titled 'A study of whether adding manual therapy, including Seitai, to a dietary program helps reduce visceral fat' on July 31.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Baumkuchen Works Inc.

Condition: Condition - Obesity (BMI 25 or higher) and/or abdominal obesity (visceral fat accumulation) in adults seeking weight reduction Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 50

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071413

Disclaimer: Curated by HT Syndication.