Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females
August 31, 2021 updated by: National Research Centre, Egypt
Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females. A Randomized Controlled Trial
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Giza
-
Cairo, Giza, Egypt, 12311
- National Research Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: laser
Subjects will receive 24 activated laser acupuncture group treatments.
The laser will be applied for 10 seconds to each of the selected acupuncture points.
In addition they will be instructed to take a tailored low caloric diet
|
GaAlAs semiconductor diode Laser Phototherapy Device
Tailored balanced low caloric diet
|
|
Active Comparator: high protein low carbohydrate diet
Subjects will be instructed to take a tailored high protein/low carbohydrate/low caloric diet.
|
A tailored high protein/low carbohydrate/low caloric diet
|
|
Sham Comparator: control
Subjects in the control group will undergo sham laser acupuncture treatment with no laser power output.
In addition they will be instructed to take a tailored low caloric diet .
|
GaAlAs semiconductor diode Laser Phototherapy Device
Tailored balanced low caloric diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
weight loss
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
decrease cardiovascular risks
Time Frame: 8 weeks
|
endothelial markers , serum insulin and insulin resistance changes from baseline.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neveen H Abou El-Soud, Ph.D, National Research Centre, Egypt
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1161/hc0702.104279.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
November 1, 2017
Study Registration Dates
First Submitted
October 5, 2015
First Submitted That Met QC Criteria
October 8, 2015
First Posted (Estimate)
October 12, 2015
Study Record Updates
Last Update Posted (Actual)
September 8, 2021
Last Update Submitted That Met QC Criteria
August 31, 2021
Last Verified
October 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- NRCEgypt
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.