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Recruiting NCT07472881

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

No phase Interventional Menopause Perimenopause Obesity Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-acupoint low-level laser therapy, Sham Laser irradiation, Diet and exercise guidance.
Who it may be relevant to
Registry conditions: Menopause, Perimenopause, Obesity, Overweight. Basic parameters: 45 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of a Multi-acupoint Laser Therapy Device on Body Shape and Body Composition in Obese Menopausal Women

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Change in body fat mass [Time frame: Baseline, Week 3, Week 4, and Week 6]
Secondary outcome measures (7)
  • Change in body weight [Time frame: Baseline, Week 3, Week 4, and Week 6]
  • Change in menopausal symptoms (Menopause Rating Scale score) [Time frame: Baseline and Week 6]
  • Change in satiety level (Visual Analog Scale) [Time frame: Baseline and Week 6]
  • Menopausal constitution classification score [Time frame: Baseline]
  • Change in skeletal muscle mass [Time frame: Baseline, Week 3, Week 4, and Week 6]
  • Change in body fat percentage [Time frame: Baseline, Week 3, Week 4, and Week 6]
  • Change in waist-to-hip ratio [Time frame: Baseline, Week 3, Week 4, and Week 6]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Chang Gung Memorial Hospital, Keelung Medical Center — Keelung

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. PMID 31473867
  • Heinemann 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. PMID 12914663
  • El-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. PMID 26425364
  • Kamal 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. PMID 39138739

Identifiers

NCT: NCT07472881 · 202501462A3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗