Combination of Light and Ultrasound to Reduce Abdominal Fat

NCT05155683 | Completed

• 1 other identifier: MMS
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Light and ultrasound can be interesting alternatives to reduce abdominal fat. Thus, the main objective of this study will be to evaluate the effects of these isolated techniques and their association in subcutaneous abdominal localized fat. These techniques will be used adding muscle electrostimulation in all groups. A total of 40 female participants will be recruited at the university outpatient, which will be distributed among four experimental groups: light + sham ultrasound + electrostimulation; light sham + ultrasound + electrostimulation; combined treatment (light + ultrasound) + electrostimulation; sham combined treatment + electrostimulation. The treatments will consist of eight sessions, twice a week for a month, being 90 minutes per session.

Conditions

Subcutaneous Fat Disorder

Keywords

LLLT; Cavitation; Photobiomodulation

Outcome Measures

Primary Outcomes (1)

• Abdominal skinfold change

  This outcome will be measured in millimeters (mm) by direct reading using adipometer (Sanny, American Medical do Brasil Ltda., São Bernardo do Campo, Brazil).

  Before the start (Day 0), after the fourth session (Day 15) and after the treatments (Day 30).

Secondary Outcomes (17)

• Anthropometric data (body weight)

  Day 0, Day 15 and Day 30.

• Anthropometric data (height)

  Day 0.

• Anthropometric data (body mass index)

  Day 0, Day 15 and Day 30.

• Anthropometric data (waist circumference)

  Day 0, Day 15 (body weight, BMI, waist and hip circumferences, abdominal and suprailiac skinfold only), and Day 30.

• Anthropometric data (hip circumference)

  Day 0, Day 15 and Day 30.

Study Arms (4)

Photobiomodulation

ACTIVE COMPARATOR

PBM with infrared LED application + sham ultrasound + muscle electrostimulation

Device: Photobiomodulation (PBM) with infrared LED; Device: Muscle electrostimulation

low frequency ultrasound

ACTIVE COMPARATOR

LED sham PBM + LOFU + muscle electrostimulation

Device: Low-frequency ultrasound (LOFU); Device: Muscle electrostimulation

Combined treatment (PBM + LOFU)

ACTIVE COMPARATOR

Combined treatment (PBM + LOFU) + muscle electrostimulation

Device: Photobiomodulation (PBM) with infrared LED; Device: Low-frequency ultrasound (LOFU); Device: Muscle electrostimulation

Sham Treatment

SHAM COMPARATOR

Sham combined treatment + muscle electrostimulation

Device: Muscle electrostimulation

Interventions

Photobiomodulation (PBM) with infrared LED DEVICE

All participants will receive 30 minutes of PBM (or PBM sham), with an abdominal strap containing 4 LED clusters with 72 devices that emit 830 nm wavelength with 20 nm spectral width, in continuous operating mode, 5 mW average radiant power per LED, 71 mW/cm² power density at aperture, 20.4 cm² of total area irradiated, 71 mW/cm² of irradiance at target, exposure duration of 1800 seconds, 127.8 J/cm² of radiant exposure, 2.6 kJ of radiant energy, per contact application technique, twice a week for a month, totaling 8 sessions.

Also known as: Low-level light therapy (LLLT)

Combined treatment (PBM + LOFU); Photobiomodulation

Low-frequency ultrasound (LOFU) DEVICE

Subsequently the demarcation of the target area for LOFU treatment (Thoor DGM Electronica, Santo André, São Paulo, Brazil), the application of the neutral conductive gel will occur for the use of low-frequency ultrasound for 30 minutes, which will occur with 22 cm² effective radiating area (ERA) size, \<8 BNR emission intensity, 40 kHz frequency, continuous mode, 60W, 100 cm² of total treated area, twice a week for a month, totaling 8 sessions.

Combined treatment (PBM + LOFU); low frequency ultrasound

Muscle electrostimulation DEVICE

The session will end with 20 minutes of Russian Current (Tensor DGM Electronica, Santo André, São Paulo, Brazil), whose carrier frequency occurs in 2500 Hz, which will be adjusted according to the parameters described by Evangelista et al. (2003), which are: pulse frequency of 30 Hz; up/down ramp of 2 seconds each; support/rest time of 13 seconds each. The current intensity used will be the maximum supported by each participant and that is comfortable and sufficient to provide visible contraction. The treatment will consist of eight sessions that will occur twice a week, totaling a month of treatment.

Combined treatment (PBM + LOFU); Photobiomodulation; Sham Treatment; low frequency ultrasound

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI of between 18.5 and 27.5 kg/m² (normotrophic or overweight body mass);
• Fitzpatrick phototype from I to IV;
• Who have fat located in the abdominal region characterized by abdominal skinfold higher than 20 mm;
• Who are sedentary of perform physical activity whose intensity is equal to or less than 450 METs/minutes/week (metabolic equivalents = METs);
• Who have stabilized weight, that is, who have not acquired or eliminated more than 2.5 kg in the 6 months preceding the screening;
• Absence of signs/symptoms of disease.

You may not qualify if:

• Women who have used drugs that alter body composition in the last 3 months prior to starting treatments; who use sensitizing agents, diuretics or are undergoing photodynamic therapy;
• Participants who are undergoing aesthetic treatments to reduce abdominal/waist circumferences; those who have been previously submitted to abdominoplasty or liposuction surgeries; those who are on a diet therapy monitoring to reduce their measurements; those who are using or have taken drugs or food supplements in last 90 days, in order to reduce their measurements and their weight, which may affect their lipid metabolism, appetite or nutrients absorption; those who have been submitted previously to oophorectomy; those with signs and/or symptoms of climacteric at the menopause; pregnant or lactating women or who are planning a pregnancy before the end of treatment participation.
• Participants who have abdominal hernia; osteoporosis; phlebitis and thrombophlebitis; autoimmune diseases; cardiovascular problems (hypertension, cardiac insufficiency, arrhythmia, thrombosis); metabolic dysfunctions (diabetes and thyroid disorders); hepatitis or other liver diseases (non-alcoholic fatty liver disease, cirrhosis); respiratory issues (asthma, chronic obstructive pulmonary disease); haematological disturbances (anaemia); renal; dermatological (reduced sensitivity); digestive disorders (gastritis, ulcers); neurological (dementia or schizophrenia), or who have cognitive impairment that may compromise the proper understanding of informed consent; who have already been affected by important inflammatory processes and/or who have a history of cancer;
• Participants who present tattoos and/or piercings in the region to be treated, who use intrauterine devices, pacemakers, or other electromagnetic implants, as well as joint prostheses.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho

São Paulo, 01504001, Brazil

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Michelle M Sena, MSc

  PhD student

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The abdomen of the participants will be cleaned by using a neutral cleansing soap. Each participant will receive safety glasses for eye protection, which will also contribute to blindness of the study. PBM will be applied when using abdominal straps as developed by Cosmedical (Mauá, São Paulo, Brazil). The abdomen strap will be covered with a sheet and that will also help with the blindness of the study. After randomization, the study population will be divided into four groups (n= 10 per group), which are: (1) Group A - PBM with infrared LED application + sham ultrasound + muscle electrostimulation; (2) Group B - LED sham PBM + ultrasound + muscle electrostimulation; (3) Group C - combined treatment (PBM + ultrasound) + muscle electrostimulation; (4) Group D - sham combined treatment + muscle electrostimulation.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 13, 2021
• Study Start: March 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be shared after 3 months after manuscript publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

BR (1)