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

NCT ID: NCT02573961

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Laser acupuncture

Intervention Type DEVICE

GaAlAs semiconductor diode Laser Phototherapy Device

low caloric diet

Intervention Type BEHAVIORAL

Tailored balanced low caloric diet

high protein low carbohydrate diet

Subjects will be instructed to take a tailored high protein/low carbohydrate/low caloric diet.

Group Type ACTIVE_COMPARATOR

high protein low carbohydrate diet

Intervention Type BEHAVIORAL

A tailored high protein/low carbohydrate/low caloric diet

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 .

Group Type SHAM_COMPARATOR

Laser acupuncture

Intervention Type DEVICE

GaAlAs semiconductor diode Laser Phototherapy Device

low caloric diet

Intervention Type BEHAVIORAL

Tailored balanced low caloric diet

Interventions

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Laser acupuncture

GaAlAs semiconductor diode Laser Phototherapy Device

Intervention Type DEVICE

high protein low carbohydrate diet

A tailored high protein/low carbohydrate/low caloric diet

Intervention Type BEHAVIORAL

low caloric diet

Tailored balanced low caloric diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neveen H Abou El-Soud, Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

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National Research Centre

Cairo, Giza Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 11854119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22935440 (View on PubMed)

Other Identifiers

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NRCEgypt

Identifier Type: -

Identifier Source: org_study_id

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