EFFECT OF CYOLIPOLYSIS DEVICE WITH VEGAN DIET VERSUS CAVITATION DEVICE WITH VEGAN DIET ON SERUM LIPID PROFILE IN WOMEN WITH CENTRAL OBESITY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Fasting serum lipid profile
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1-Their ages will be ranged between 25-40 year old.
- •2-Their body mass index will be ranged between 35:39.9 kg/m
- •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.
排除标准
- •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
结局指标
主要结局
Fasting serum lipid profile
时间窗: Three months
Pre/post Fasting serum lipid profile
次要结局
- Waist circumference(Three months)
研究者
Amira Abdelwhab
EFFECT OF CYOLIPOLYSIS DEVICE WITH VEGAN DIET VERSUS CAVITATION DEVICE WITH VEGAN DIET ON SERUM LIPID PROFILE IN WOMEN WITH CENTRAL OBESITY
Cairo University