An interventional study of Cryolipolysis and cavitation devices with vegan diet in Healthy Adult Women, sponsored by Cairo University. Not yet recruiting. Open to female participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
Pre/ posttest randomized controlled trial design.
In this study all females will be randomly assigned into three groups (20 for each group).
Treatment Protocol:
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.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
•Group A will receive cryolipolysis with vegan diet,
Other: Cryolipolysis and cavitation devices with vegan diet
Group B will receive cavitation with vegan diet
Other: Cryolipolysis and cavitation devices with vegan diet
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).
Fasting serum lipid profile
Pre/post Fasting serum lipid profile
Time frame: Three months
Waist circumference
All women will have central obesity in abdominal region their waist circumference \>102cm (40in).
Time frame: Three months
No study locations are listed for this record.
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Cairo University