EFFECT OF CYOLIPOLYSIS VERSUS CAVITATION WITH VEGAN DIET

EFFECT OF CYOLIPOLYSIS DEVICE WITH VEGAN DIET VERSUS CAVITATION DEVICE WITH VEGAN DIET ON SERUM LIPID PROFILE IN WOMEN WITH CENTRAL OBESITY

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Women
• Intervention / Treatment: Other: Cryolipolysis and cavitation devices with vegan diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; •Group A will receive cryolipolysis with vegan diet,	Other: Cryolipolysis and cavitation devices with vegan diet; Cryolipolysis: In all cases of group A, (OPTIMIZED CRYOLIPOLYSIS 360 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). •Cavitation: in all cases of group B, (CAVITATION DEVICE, Item No.:AU61, Made in china) of 45 KHz frequency (30 min twice weekly for three successive3 months).
Experimental: Group B; Group B will receive cavitation with vegan diet	Other: Cryolipolysis and cavitation devices with vegan diet; Cryolipolysis: In all cases of group A, (OPTIMIZED CRYOLIPOLYSIS 360 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). •Cavitation: in all cases of group B, (CAVITATION DEVICE, Item No.:AU61, Made in china) of 45 KHz frequency (30 min twice weekly for three successive3 months).
Experimental: Group C; Group C will receive vegan diet only.	Other: Cryolipolysis and cavitation devices with vegan diet; Cryolipolysis: In all cases of group A, (OPTIMIZED CRYOLIPOLYSIS 360 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). •Cavitation: in all cases of group B, (CAVITATION DEVICE, Item No.:AU61, Made in china) of 45 KHz frequency (30 min twice weekly for three successive3 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting serum lipid profile	Pre/post Fasting serum lipid profile	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	All women will have central obesity in abdominal region their waist circumference >102cm (40in).	Three months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 20, 2023
• First Submitted That Met QC Criteria: August 20, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: P.T.REC/012/004629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: One year after completion the study
• IPD Sharing Access Criteria: Students and scientific researchers will be allowed to access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No