Clinical trial NCT06009952: EFFECT OF CYOLIPOLYSIS VERSUS CAVITATION WITH VEGAN DIET
Official title: EFFECT OF CYOLIPOLYSIS DEVICE WITH VEGAN DIET VERSUS CAVITATION DEVICE WITH VEGAN DIET ON SERUM LIPID PROFILE IN WOMEN WITH CENTRAL OBESITY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Adult Women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: •Pre/ posttest randomized controlled trial design.
Primary purpose: TREATMENT

Brief summary: Pre/ posttest randomized controlled trial design.

In this study all females will be randomly assigned into three groups (20 for each group).

* Group A will receive cryolipolysis with vegan diet,
* Group B will receive cavitation with vegan diet and
* Group C will receive vegan diet only.

Detailed description: Treatment Protocol:

1. Cryolipolysis: In all cases of group A, (OPTIMIZED 360 CRYOLIPOLYSIS DEVICE, model: AF2000-02, made in china) uses a vacuum-based huge applicator (Cool Max) and vacuum medium applicators (either CoolCore or Cool- Curveþ) for the abdomen (30 minutes session twice monthly for three successive3 months). The subcutaneous-fat layer in the regions of the abdomen will be treated with cryolipolysis. It will be cooled to (-8∘ C) for 30 minutes with the cryolipolysis device Areas will be treated with either the medium or large applicator, based on the size of the localized fat area and the anatomical limitations of the applicator placement.

The treatment sessions will be performed with the subjects comfortably positioned in the dorsal decubitus position with a 45∘ stretcher inclination or in the lateral decubitus position. The curved vacuum applicator will be positioned in the center of the treatment area, and vacuum suction will be initiated. The vacuum itself will be fixed the applicator over the treatment area, and pillows will be supported the applicator during the entire treatment.

The cavitation instrument generates low-frequency ultrasonic pulsed waves 45kHz through a transducer with a diameter of 45 mm and a power of 3 watts/cm2. The individual will be positioned in a comfortable supine posture, and the transducer will be placed on an abdominal region already coated with conduction gel. For three months, abdomen area will be treated with one 30-minute session twice weekly. The patient will be treated in a relaxed supine resting position.

Diet intervention:

A well-balanced vegan diet( Lacto-ovo vegetarian diet) excludes meat, fish and poultry, but allows dairy products and eggs.Vegetarian diet: Daily amounts will be based on 2,000-calorie diet.

It should be characterized by a high intake of fiber (≥45-60 g/day), a moderate intake of protein (\<15% of energy), and a low intake of total fat (10-20% of energy), saturated fat (≤5% of energy), free sugars (\<5% of energy) and sodium (1500 mg/day). The required supplementation must include reliable sources of vitamin B12 for the whole year and vitamin D in the winter months (vitamin fortified foods and/or a supplement), and optionally may include EPA/DHA throughout the year.

Eligibility criteria: Inclusion Criteria:

* 1-Their ages will be ranged between 25-40 year old.

  2-Their body mass index will be ranged between 35:39.9 kg/m2. 3-All women will have central obesity in abdominal region their waist circumference \>102cm (40in).

  4-The average number of previous deliveries for all women is 4 times. 5-Included fasting serum lipid profile will be in borderline and high risk ranges.

Exclusion Criteria:

* Epileptic fits.

  * Cardiac affection and using pace maker.
  * Heavy Smokers.
  * Renal, liver or endocrinal disorder.
  * Pulmonary or lung diseases.
  * Pregnant women.
  * Patients receiving any drug therapy such as lipid lowering therapy, vitamins and antioxidants.
  * Weight reduction medications

Primary outcomes:
measure: Fasting serum lipid profile
timeFrame: Three months
Secondary outcomes:
measure: Waist circumference
timeFrame: Three months
Other outcomes:
Locations:
Study officials:
References: