Study Stopped
This was a topic for a thesis project where the topic was changed
Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
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Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedSeptember 8, 2021
October 1, 2015
2 years
October 5, 2015
August 31, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
weight loss
8 weeks
Secondary Outcomes (1)
decrease cardiovascular risks
8 weeks
Study Arms (3)
laser
ACTIVE COMPARATORSubjects 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
high protein low carbohydrate diet
ACTIVE COMPARATORSubjects will be instructed to take a tailored high protein/low carbohydrate/low caloric diet.
control
SHAM COMPARATORSubjects 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 .
Interventions
A tailored high protein/low carbohydrate/low caloric diet
Eligibility Criteria
You may qualify if:
- obese females of BMI more than 30 kg/m2, and
- of age range from 20 to 50 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Research Centre
Cairo, Giza Governorate, 12311, Egypt
Related Publications (2)
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.
PMID: 11854119BACKGROUNDSoenen 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.
PMID: 22935440BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neveen H Abou El-Soud, Ph.D
National Research Centre, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 12, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2017
Study Completion
November 1, 2017
Last Updated
September 8, 2021
Record last verified: 2015-10