Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females

Obesity Clinical Trial

Official title:

Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females. A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02573961
• Other study ID #: NRCEgypt
• Status: Withdrawn
• Phase: N/A
• Start date: October 2015
• Est. completion date: November 2017

Study information

• Verified date: October 2015
• Source: National Research Centre, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of laser acupuncture and high protein low carbohydrate diet on the treatment of obesity and lowering of endothelial markers.

Description:

Sixty females above 20 years of age with a body mass index (BMI) of over 30 kg/m2 will be divided into three groups (20 in each): two experimental groups (laser; high protein low carbohydrate diet) and control. Each subject will receive the treatment relevant to their group, in addition to obtaining 3 days dietary recalls and measurements including BMI, serum insulin and endothelial markers. Laser and control group will receive 24 activated or sham laser acupuncture treatments. High protein low carbohydrate group will be instructed to take a tailored high protein/low carbohydrate diet.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• obese females of BMI more than 30 kg/m2, and

• of age range from 20 to 50 years.

Exclusion Criteria:

• medical history of chronic diseases,

• pregnancy,

• photosensitivity reactions to laser treatment,

• a pacemaker,

• medications known to affect one's weight up to 1 month in advance, or

• are unwilling to comply with the study protocol.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Laser acupuncture
GaAlAs semiconductor diode Laser Phototherapy Device

Behavioral:
• high protein low carbohydrate diet
A tailored high protein/low carbohydrate/low caloric diet
• low caloric diet
Tailored balanced low caloric diet

Locations

Country	Name	City	State
Egypt	National Research Centre	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Soenen S, Bonomi AG, Lemmens SG, Scholte J, Thijssen MA, van Berkum F, Westerterp-Plantenga MS. Relatively high-protein or 'low-carb' energy-restricted diets for body weight loss and body weight maintenance? Physiol Behav. 2012 Oct 10;107(3):374-80. doi: 10.1016/j.physbeh.2012.08.004. Epub 2012 Aug 19. — View Citation

Ziccardi P, Nappo F, Giugliano G, Esposito K, Marfella R, Cioffi M, D'Andrea F, Molinari AM, Giugliano D. Reduction of inflammatory cytokine concentrations and improvement of endothelial functions in obese women after weight loss over one year. Circulation. 2002 Feb 19;105(7):804-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		8 weeks
Secondary	decrease cardiovascular risks	endothelial markers , serum insulin and insulin resistance changes from baseline.	8 weeks