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

NCT07472881 | Recruiting

• 1 other identifier: 202501462A3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Perimenopause; Obesity; Overweight

Keywords

Laser acupuncture; Low-level laser therapy; Obesity; Menopause; Body composition; Weight management; Acupoint stimulation; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 3, Week 4, and Week 6

Secondary Outcomes (7)

• Change in body weight

  Baseline, Week 3, Week 4, and Week 6

• Change in menopausal symptoms (Menopause Rating Scale score)

  Baseline and Week 6

• Change in satiety level (Visual Analog Scale)

  Baseline and Week 6

• Menopausal constitution classification score

  Baseline

• Change in skeletal muscle mass

  Baseline, Week 3, Week 4, and Week 6

Study Arms (2)

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.

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.

Device: Sham Laser irradiation; Behavioral: Diet and exercise guidance

Interventions

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).

Laser Acupuncture Group

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).

Control Group

Diet and exercise guidance BEHAVIORAL

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

Control Group; Laser Acupuncture Group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: Sex: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Keelung Medical Center

Keelung, Taiwan, Taiwan

RECRUITING

Related Publications (8)

• 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.

  RESULT

• 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.

  RESULT

• Comparing the Efficacy of a Dual-Frequency LLLT Device With a Sham Device as a Therapy for Adipose Tissue Loss. ClinicalTrials.gov Identifier: NCT03811093.

  RESULT

• Low-level laser therapy for weight reduction : a randomized pilot study, Ivana T. Croghan, R. T. Hurt , D.R. Schroeder, S. C. Fokken, M. D. Jensen, M. M. Clark, J. O. Ebbert, Lasers in Medical Science (2020) 35:663-675

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Yu Wei Chang

CONTACT

886-02-24313131#2677; yenlin@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participants and investigators administering the treatment will be blinded to group assignment. The control group will receive a sham laser treatment that mimics the appearance and procedure of the active laser therapy but does not emit therapeutic laser energy. Outcome assessors will also be blinded to group allocation to reduce assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 16, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): January 24, 2029
• Study Completion (Estimated): January 24, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)