EFFECT OF CYOLIPOLYSIS VERSUS CAVITATION WITH VEGAN DIET

NCT06009952 | Unknown DMC

• 1 other identifier: P.T.REC/012/004629
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Adult Women

Outcome Measures

Primary Outcomes (1)

• Fasting serum lipid profile

  Pre/post Fasting serum lipid profile

  Three months

Secondary Outcomes (1)

• Waist circumference

  Three months

Study Arms (3)

Group A

EXPERIMENTAL

•Group A will receive cryolipolysis with vegan diet,

Other: Cryolipolysis and cavitation devices with vegan diet

Group B

EXPERIMENTAL

Group B will receive cavitation with vegan diet

Other: Cryolipolysis and cavitation devices with vegan diet

Group C

EXPERIMENTAL

Group C will receive vegan diet only.

Other: Cryolipolysis and cavitation devices with vegan diet

Interventions

Cryolipolysis and cavitation devices with vegan diet OTHER

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).

Group A; Group B; Group C

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Their ages will be ranged between 25-40 year old.
• 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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Diet, Vegan

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EFFECT OF CYOLIPOLYSIS DEVICE WITH VEGAN DIET VERSUS CAVITATION DEVICE WITH VEGAN DIET ON SERUM LIPID PROFILE IN WOMEN WITH CENTRAL OBESITY

Model Details: •Pre/ posttest randomized controlled trial design.

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: August 31, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after completion the study
• Access Criteria: Students and scientific researchers will be allowed to access