MenopauseNCT07472881
Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women
A study testing Multi-acupoint low-level laser therapy and Diet and exercise guidance in people with Menopause and Perimenopause, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Perimenopause, Obesity
- What is being tested?
- Multi-acupoint low-level laser therapy and Diet and exercise guidance
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2026to 24 Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged 45 to 55 years
- No cognitive impairment or major psychiatric disorder
- Able to understand the study procedures and communicate with research staff
- Body mass index (BMI) > 24 kg/m² OR waist-to-hip ratio > 0.88
Who cannot join
- Pregnant or possibly pregnant women
- Diagnosed chronic diseases currently under active treatment, including hepatitis, chronic kidney disease, chronic gastrointestinal disease, cardiovascular disease, or cancer
- Systemic diseases such as hyperthyroidism, hypothyroidism, compensated liver cirrhosis, or autoimmune disorders
- Currently receiving weight control treatment, including bariatric surgery or weight-loss medications
- History of epilepsy or seizure disorder
- Coagulation disorders or current use of anticoagulant therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Keelung Medical Center
Keelung, Taiwan
Yu Wei Chang, +886 975360678
About this study
Official title: Effects of a Multi-acupoint Laser Therapy Device on Body Shape and Body Composition in Obese Menopausal Women
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.
Read the 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
- Menopause, Perimenopause, Obesity, Overweight
- Being tested
- Multi-acupoint low-level laser therapy, Sham Laser irradiation, Diet and exercise guidance
- Keywords
- Laser acupuncture, Low-level laser therapy, Obesity, Menopause, Body composition, Weight management, Acupoint stimulation, Randomized controlled trial
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-acupoint low-level laser therapyDevice
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).
Sham Laser irradiationDevice
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).
Diet and exercise guidanceBehavioural
WHO guideline-based diet and exercise counseling; weekly 5-10 minute sessions including waist, hip, and body composition monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Laser Acupuncture Group | Experimental | Participants receive multi-acupoint low-level laser therapy combined with diet and exercise guidance. Treatment is delivered twice weekly for 6 weeks (12 sessions total), targeting 10 specific acupoints related to weight management. Body composition and menopausal symptom assessments will be conducted at baseline, mid-treatment, and post-treatment. Receives: Device: Multi-acupoint low-level laser therapy; Behavioral: Diet and exercise guidance |
| Control Group | Sham comparator | Participants receive sham laser treatment combined with diet and exercise guidance. The sham procedure mimics the appearance and treatment process of active laser therapy but does not emit therapeutic laser energy. Participants will receive treatment twice weekly for 6 weeks (12 sessions total). Body composition and menopausal symptom assessments will be conducted at baseline, mid-treatment, and post-treatment. Receives: Device: Sham Laser irradiation; Behavioral: Diet and exercise guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat mass
Body fat mass (kg) measured using bioelectrical impedance analysis (InBody body composition analyzer). Measurements will be performed by trained research staff.
Measured: Baseline, Week 3, Week 4, and Week 6
Secondary outcomes (7)
Change in body weight
Body weight (kg) measured using the InBody body composition analyzer.
Measured: Baseline, Week 3, Week 4, and Week 6
Change in menopausal symptoms (Menopause Rating Scale score)
Menopausal symptoms assessed using the validated Traditional Chinese version of the Menopause Rating Scale (MRS). The MRS consists of 11 items scored from 0-4, total score range 0-44, with higher scores indicating more severe symptoms.
Measured: Baseline and Week 6
Change in satiety level (Visual Analog Scale)
Satiety level assessed using a 100-mm visual analog scale (VAS), where 0 indicates "not satisfied at all" and 100 indicates "extremely satisfied." Participants will rate their average satiety over the past 7 days.
Measured: Baseline and Week 6
Menopausal constitution classification score
Menopausal constitution assessed using the 37-item Questionnaire of Menopausal Constitution. Scores are calculated according to published scoring criteria, with transformed scores ranging from 0-100 for six constitution types.
Measured: Baseline
Change in skeletal muscle mass
Skeletal muscle mass (kg) measured using the InBody body composition analyzer.
Measured: Baseline, Week 3, Week 4, and Week 6
Change in body fat percentage
Body fat percentage (%) measured using the InBody body composition analyzer.
Measured: Baseline, Week 3, Week 4, and Week 6
Change in waist-to-hip ratio
Waist-to-hip ratio calculated from waist and hip circumference measurements.
Measured: Baseline, Week 3, Week 4, and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start16 Mar 2026
- Primary completion24 Jan 2029 (estimated)
- Study completion24 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random 1:1 allocation: Experimental vs. Control Experimental group: Laser acupuncture + diet/exercise Control group: Sham laser + diet/exercise Assessments at baseline, mid-treatment, post-treatmen
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472881
- Sponsor's protocol ID
- 202501462A3
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable - this is a small, non-commercial pilot study
Publications
衛生福利部國民健康署. 婦女更年期保健手冊 - 更年期不適症狀評估量表. (Taipei: 國民健康署). Year.
Gong Y-Y, Guo B-Z, et al. 更年期證型與自律神經相關性研究. 中醫藥雜誌. 2012;23(1). DOI: 10.6940/JCM.201206_23(1).01.
Comparing the Efficacy of a Dual-Frequency LLLT Device With a Sham Device as a Therapy for Adipose Tissue Loss. ClinicalTrials.gov Identifier: NCT03811093.
Croghan IT, Hurt RT, Schroeder DR, Fokken SC, Jensen MD, Clark MM, Ebbert JO. Low-level laser therapy for weight reduction: a randomized pilot study. Lasers Med Sci. 2020 Apr;35(3):663-675. doi: 10.1007/s10103-019-02867-5. Epub 2019 Aug 31.
PubMed 31473867Heinemann LA, Potthoff P, Schneider HP. International versions of the Menopause Rating Scale (MRS). Health Qual Life Outcomes. 2003 Jul 30;1:28. doi: 10.1186/1477-7525-1-28.
PubMed 12914663El-Mekawy HS, ElDeeb AM, Ghareib HO. Effect of laser acupuncture combined with a diet-exercise intervention on metabolic syndrome in post-menopausal women. J Adv Res. 2015 Sep;6(5):757-63. doi: 10.1016/j.jare.2014.08.002. Epub 2014 Aug 19.
PubMed 26425364Kamal WM, Maged AM, AbdelAziz S, Mahmoud SI, Mohsen RA. The effects of laser acupuncture on metabolic syndrome in obese postmenopausal women: a randomized controlled study. Lasers Med Sci. 2024 Aug 14;39(1):215. doi: 10.1007/s10103-024-04158-0.
PubMed 39138739