xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06009952</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/004629</org_study_id>
      <nct_id>NCT06009952</nct_id>
    </id_info>
    <brief_title>EFFECT OF CYOLIPOLYSIS VERSUS CAVITATION WITH VEGAN DIET</brief_title>
    <official_title>EFFECT OF CYOLIPOLYSIS DEVICE WITH VEGAN DIET VERSUS CAVITATION DEVICE WITH VEGAN DIET ON SERUM LIPID PROFILE IN WOMEN WITH CENTRAL OBESITY</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Pre/ posttest randomized controlled trial design.&#xD;
  &#xD;
        In this study all females will be randomly assigned into three groups (20 for each group).&#xD;
  &#xD;
          -  Group A will receive cryolipolysis with vegan diet,&#xD;
  &#xD;
          -  Group B will receive cavitation with vegan diet and&#xD;
  &#xD;
          -  Group C will receive vegan diet only.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Treatment Protocol:&#xD;
  &#xD;
        1. Cryolipolysis: In all cases of group A, (OPTIMIZED 360 CRYOLIPOLYSIS DEVICE, model:&#xD;
        AF2000-02, made in china) uses a vacuum-based huge applicator (Cool Max) and vacuum medium&#xD;
        applicators (either CoolCore or Cool- Curveþ) for the abdomen (30 minutes session twice&#xD;
        monthly for three successive3 months). The subcutaneous-fat layer in the regions of the&#xD;
        abdomen will be treated with cryolipolysis. It will be cooled to (-8∘ C) for 30 minutes with&#xD;
        the cryolipolysis device Areas will be treated with either the medium or large applicator,&#xD;
        based on the size of the localized fat area and the anatomical limitations of the applicator&#xD;
        placement.&#xD;
  &#xD;
        The treatment sessions will be performed with the subjects comfortably positioned in the&#xD;
        dorsal decubitus position with a 45∘ stretcher inclination or in the lateral decubitus&#xD;
        position. The curved vacuum applicator will be positioned in the center of the treatment&#xD;
        area, and vacuum suction will be initiated. The vacuum itself will be fixed the applicator&#xD;
        over the treatment area, and pillows will be supported the applicator during the entire&#xD;
        treatment.&#xD;
  &#xD;
        The cavitation instrument generates low-frequency ultrasonic pulsed waves 45kHz through a&#xD;
        transducer with a diameter of 45 mm and a power of 3 watts/cm2. The individual will be&#xD;
        positioned in a comfortable supine posture, and the transducer will be placed on an abdominal&#xD;
        region already coated with conduction gel. For three months, abdomen area will be treated&#xD;
        with one 30-minute session twice weekly. The patient will be treated in a relaxed supine&#xD;
        resting position.&#xD;
  &#xD;
        Diet intervention:&#xD;
  &#xD;
        A well-balanced vegan diet( Lacto-ovo vegetarian diet) excludes meat, fish and poultry, but&#xD;
        allows dairy products and eggs.Vegetarian diet: Daily amounts will be based on 2,000-calorie&#xD;
        diet.&#xD;
  &#xD;
        It should be characterized by a high intake of fiber (≥45-60 g/day), a moderate intake of&#xD;
        protein (&lt;15% of energy), and a low intake of total fat (10-20% of energy), saturated fat&#xD;
        (≤5% of energy), free sugars (&lt;5% of energy) and sodium (1500 mg/day). The required&#xD;
        supplementation must include reliable sources of vitamin B12 for the whole year and vitamin D&#xD;
        in the winter months (vitamin fortified foods and/or a supplement), and optionally may&#xD;
        include EPA/DHA throughout the year.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>•Pre/ posttest randomized controlled trial design.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fasting serum lipid profile</measure>
      <time_frame>Three months</time_frame>
      <description>Pre/post Fasting serum lipid profile</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Waist circumference</measure>
      <time_frame>Three months</time_frame>
      <description>All women will have central obesity in abdominal region their waist circumference &gt;102cm (40in).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Healthy Adult Women</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>•Group A will receive cryolipolysis with vegan diet,</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group B will receive cavitation with vegan diet</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group C will receive vegan diet only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cryolipolysis and cavitation devices with vegan diet</intervention_name>
      <description>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).&#xD;
  •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).</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_label>Group C</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1-Their ages will be ranged between 25-40 year old.&#xD;
  &#xD;
               2-Their body mass index will be ranged between 35:39.9 kg/m2. 3-All women will have&#xD;
               central obesity in abdominal region their waist circumference &gt;102cm (40in).&#xD;
  &#xD;
               4-The average number of previous deliveries for all women is 4 times. 5-Included&#xD;
               fasting serum lipid profile will be in borderline and high risk ranges.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Epileptic fits.&#xD;
  &#xD;
                 -  Cardiac affection and using pace maker.&#xD;
  &#xD;
                 -  Heavy Smokers.&#xD;
  &#xD;
                 -  Renal, liver or endocrinal disorder.&#xD;
  &#xD;
                 -  Pulmonary or lung diseases.&#xD;
  &#xD;
                 -  Pregnant women.&#xD;
  &#xD;
                 -  Patients receiving any drug therapy such as lipid lowering therapy, vitamins and&#xD;
                    antioxidants.&#xD;
  &#xD;
                 -  Weight reduction medications&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Amira Abdelwhab</investigator_full_name>
      <investigator_title>EFFECT OF CYOLIPOLYSIS DEVICE WITH VEGAN DIET VERSUS CAVITATION DEVICE WITH VEGAN DIET ON SERUM LIPID PROFILE IN WOMEN WITH CENTRAL OBESITY</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>One year after completion the study</ipd_time_frame>
      <ipd_access_criteria>Students and scientific researchers will be allowed to access</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06009952
  org study id: P.T.REC/012/004629
  nct id: NCT06009952
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: •Pre/ posttest randomized controlled trial design.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Fasting serum lipid profile
  time frame: Three months
  description: Pre/post Fasting serum lipid profile
  measure: Waist circumference
  time frame: Three months
  description: All women will have central obesity in abdominal region their waist circumference >102cm (40in).
  arm group label: Group A
  arm group type: Experimental
  description: •Group A will receive cryolipolysis with vegan diet,
  arm group label: Group B
  arm group type: Experimental
  description: Group B will receive cavitation with vegan diet
  arm group label: Group C
  arm group type: Experimental
  description: Group C will receive vegan diet only.
  intervention type: Other
  intervention name: Cryolipolysis and cavitation devices with vegan diet
  description: 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).
  arm group label: Group A
  arm group label: Group B
  arm group label: Group C
  criteria: 
  gender: Female
  minimum age: 25 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Amira Abdelwhab
  investigator title: EFFECT OF CYOLIPOLYSIS DEVICE WITH VEGAN DIET VERSUS CAVITATION DEVICE WITH VEGAN DIET ON SERUM LIPID PROFILE IN WOMEN WITH CENTRAL OBESITY
  sharing ipd: Yes
  ipd description: All IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd time frame: One year after completion the study
  ipd access criteria: Students and scientific researchers will be allowed to access