Clinical trial NCT05155683: Combination of Light and Ultrasound to Reduce Abdominal Fat
Official title: Comparative Study of the Use of Phototherapy and Ultrasound to Reduce Localized Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subcutaneous Fat Disorder
Keywords: LLLT
Cavitation
Photobiomodulation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 79
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The search for the ideal shape and the lifestyle that favours the increase of adipose depots are some factors responsible for the increasing demand for procedures to reduce localized fat. It has been shown that photobiomodulation (PBM) and low-frequency ultrasound (LOFU) can be interesting alternatives to treat this aesthetic dysfunction. However, there is no consensus about the best parameters for the application of these therapeutic resources. 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.This will be a controlled, randomised, double-blind, single-centred clinical trial. Infrared light emitting diode - LED - (830±20 nm, 71 milliwatt per square centimeter mW/cm², 127.8 J/cm²), low-frequency ultrasound (30 kilohertz (kHz), 3 W/cm²) and combination of techniques will be used, adding muscle electrostimulation in all groups (2500 Hz, 30 bps, 50%). A total of 40 female participants will be recruited at the university outpatient, which will be distributed among four experimental groups that will compose the pilot study: PBM + sham ultrasound + electromyostimulation; PBM sham + LOFU + electromyostimulation; combined treatment (PBM + LOFU) + electromyostimulation; sham combined treatment + electromyostimulation. At each session, the participants will receive 30 minutes PBM with an abdominal strap, subsequent demarcation on the target area to be treated with LOFU for 30 minutes and completion with 20 minutes of electrically induced muscle contraction. The treatments will consist of eight sessions, twice a week for a month. The main outcome of this study will be abdominal skinfold reduction and the secondary variables will be including anthropometric data, local temperature, nutritional routine and physical activity data, quality of life, self-esteem, satisfaction grade with the treatment and visual changes.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Abdominal skinfold change
timeFrame: Before the start (Day 0), after the fourth session (Day 15) and after the treatments (Day 30).
Secondary outcomes:
measure: Anthropometric data (body weight)
timeFrame: Day 0, Day 15 and Day 30.
measure: Anthropometric data (height)
timeFrame: Day 0.
measure: Anthropometric data (body mass index)
timeFrame: Day 0, Day 15 and Day 30.
measure: Anthropometric data (waist circumference)
timeFrame: Day 0, Day 15 (body weight, BMI, waist and hip circumferences, abdominal and suprailiac skinfold only), and Day 30.
measure: Anthropometric data (hip circumference)
timeFrame: Day 0, Day 15 and Day 30.
measure: Anthropometric data (waist/hip circumference ratio)
timeFrame: Day 0, Day 15 and Day 30.
measure: Anthropometric data (skinfold measures)
timeFrame: Day 0, Day 15 (abdominal and suprailiac skinfolds only), and Day 30.
measure: Local temperature
timeFrame: Day 0 and Day 30.
measure: Bioimpedance analysis (weight)
timeFrame: Day 0 and Day 30.
measure: Bioimpedance analysis (fat mass percentage)
timeFrame: Day 0 and Day 30.
measure: Bioimpedance analysis (lean mass percentage)
timeFrame: Day 0 and Day 30.
measure: Nutritional assessment
timeFrame: Day 0, during the study period (3 times per week) and Day 30.
measure: Physical activity assessment
timeFrame: Day 0, Day 15 and Day 30.
measure: Quality of life scale
timeFrame: Day 0 and Day 30.
measure: Self-esteem scale
timeFrame: Day 0 and Day 30.
measure: Visual change assessment
timeFrame: Day 0 and Day 30.
measure: Satisfaction degree with treatment
timeFrame: Day 30.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
Study officials:
affiliation: PhD student
name: Michelle M Sena, MSc
role: STUDY_CHAIR
References: