Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07472881

Multi-Acupoint Laser Therapy for Body Shape and 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Menopause Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Perimenopause Signs and Symptoms

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Keelung Medical Center

Keelung, Taiwan

Location status: Recruiting

Location contact

Yu Wei Chang

CONTACT

+886 975360678

About this study

*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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-acupoint low-level laser therapy

Device

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 irradiation

Device

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 guidance

Behavioral

WHO guideline-based diet and exercise counseling; weekly 5-10 minute sessions including waist, hip, and body composition monitoring.

Primary outcomes

  1. Change in body fat mass

    Time frame: Baseline, Week 3, Week 4, and Week 6

    Body fat mass (kg) measured using bioelectrical impedance analysis (InBody body composition analyzer). Measurements will be performed by trained research staff.

Secondary outcomes

  1. Change in body weight

    Time frame: Baseline, Week 3, Week 4, and Week 6

    Body weight (kg) measured using the InBody body composition analyzer.

  2. Change in menopausal symptoms (Menopause Rating Scale score)

    Time frame: Baseline and Week 6

    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.

  3. Change in satiety level (Visual Analog Scale)

    Time frame: Baseline and Week 6

    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.

  4. Menopausal constitution classification score

    Time frame: Baseline

    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.

  5. Change in skeletal muscle mass

    Time frame: Baseline, Week 3, Week 4, and Week 6

    Skeletal muscle mass (kg) measured using the InBody body composition analyzer.

  6. Change in body fat percentage

    Time frame: Baseline, Week 3, Week 4, and Week 6

    Body fat percentage (%) measured using the InBody body composition analyzer.

  7. Change in waist-to-hip ratio

    Time frame: Baseline, Week 3, Week 4, and Week 6

    Waist-to-hip ratio calculated from waist and hip circumference measurements.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Wei Chang

CONTACT

[email protected]

886-02-24313131#2677

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 16, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.