Trials / Recruiting
RecruitingNCT07472881
Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women
Effects of a Multi-acupoint Laser Therapy Device on Body Shape and Body Composition in Obese Menopausal Women
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Chang Gung Memorial Hospital · Academic / Other
- Sex
- Female
- Age
- 45 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to integrate Traditional Chinese Medicine (TCM) theory and therapeutic methods with modern low-level laser stimulation on corresponding acupoints, applying this combined approach to the field of weight management in menopausal women. The trial aims to investigate whether lifestyle modifications in accordance with WHO guidelines (dietary control and exercise), combined with adjunctive low-level laser acupuncture, can enhance weight reduction and improve body composition more effectively than standard lifestyle interventions alone.
Detailed description
\*Study Objective: Investigate the effects of multi-acupoint low-level laser therapy on body composition in obese menopausal women, combining traditional Chinese medicine theory with laser stimulation of specific acupoints, alongside lifestyle interventions including diet and exercise according to WHO guidelines. \*Participants: Total: 40 women, aged 45-55 years BMI \> 24 kg/m² or waist-to-hip ratio \> 0.88 Recruited from the outpatient clinic Randomly assigned to either the laser acupuncture group or control group \*Intervention: Experimental group: 12 sessions of laser acupuncture over 6 weeks Each session: 30 minutes, targeting 10 acupoints related to weight management Both groups: standardized diet and exercise guidance per WHO recommendations \*Primary Endpoints: Body composition changes:Body fat mass, Body fat percentage, Skeletal muscle mass, Total body weight, Limb muscle mass, Waist-to-hip ratio * Secondary Endpoints: Menopausal symptoms (Menopause Rating Scale, MRS), Satiety levels (Visual Analog Scale, VAS) * Assessments: Conducted at baseline, mid-treatment, and post-treatment Safety and tolerability monitored throughout the study \*Statistical Analysis: Software: SPSS Methods: Independent t-tests, paired t-tests, Chi-square tests, correlation, regression analyses Significance: p \< 0.05
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Multi-acupoint low-level laser therapy | Low-level laser therapy, 780 nm wavelength, 30 minutes per session, 12 sessions over 6 weeks, targeting 10 acupoints: bilateral Shenshu (BL23), Sanyinjiao (SP6), Tianshu (ST25), Shuifen (CV9), Guanyuan (CV4), and Dàdài (GB26). |
| DEVICE | Sham Laser irradiation | Sham laser treatment that mimics the appearance and procedure of active low-level laser therapy but does not emit therapeutic laser energy. Sessions are conducted twice weekly for 6 weeks (12 sessions total). |
| BEHAVIORAL | Diet and exercise guidance | WHO guideline-based diet and exercise counseling; weekly 5-10 minute sessions including waist, hip, and body composition monitoring. |
Timeline
- Start date
- 2026-03-16
- Primary completion
- 2029-01-24
- Completion
- 2029-01-24
- First posted
- 2026-03-16
- Last updated
- 2026-03-20
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT07472881. Inclusion in this directory is not an endorsement.