Healthy Adult WomenNCT06009952
EFFECT OF CYOLIPOLYSIS VERSUS CAVITATION WITH VEGAN DIET
A study testing Cryolipolysis and cavitation devices with vegan diet in people with Healthy Adult Women, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Women
- What is being tested?
- Cryolipolysis and cavitation devices with vegan diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the detailed description
Treatment Protocol:
- 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.
- Conditions
- Healthy Adult Women
- Being tested
- Cryolipolysis and cavitation devices with vegan diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryolipolysis and cavitation devices with vegan dietOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | •Group A will receive cryolipolysis with vegan diet, Receives: Other: Cryolipolysis and cavitation devices with vegan diet |
| Group B | Experimental | Group B will receive cavitation with vegan diet Receives: Other: Cryolipolysis and cavitation devices with vegan diet |
| Group C | Experimental | Group C will receive vegan diet only. Receives: Other: Cryolipolysis and cavitation devices with vegan diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting serum lipid profile
Pre/post Fasting serum lipid profile
Measured: Three months
Secondary outcomes (1)
Waist circumference
All women will have central obesity in abdominal region their waist circumference >102cm (40in).
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start31 Aug 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult WomenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- •Pre/ posttest randomized controlled trial design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Abdelwhab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009952
- Sponsor's protocol ID
- P.T.REC/012/004629
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF CYOLIPOLYSIS DEVICE WITH VEGAN DIET VERSUS CAVITATION DEVICE WITH VEGAN DIET ON SERUM LIPID PROFILE IN WOMEN WITH CENTRAL OBESITY
- ClinicalTrials.gov ID
- NCT06009952
- Acronym / sponsor ID
- P.T.REC/012/004629
- Conditions
- Healthy Adult Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 Aug 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- •Pre/ posttest randomized controlled trial design.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Cryolipolysis and cavitation devices with vegan diet•Group A will receive cryolipolysis with vegan diet, |
| Group B | Experimental | Other: Cryolipolysis and cavitation devices with vegan dietGroup B will receive cavitation with vegan diet |
| Group C | Experimental | Other: Cryolipolysis and cavitation devices with vegan dietGroup C will receive vegan diet only. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Epileptic fits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryolipolysis and cavitation devices with vegan dietCryolipolysis: 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). | Other | Group A, Group B, Group C |
Primary outcome
Fasting serum lipid profile
Time frame: Three months
Pre/post Fasting serum lipid profile
1 secondary outcome
Waist circumference
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cryolipolysis and cavitation devices with vegan diet in people with Healthy Adult Women, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting serum lipid profile (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.