ObesityNCT02573961
Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females
A study testing Laser acupuncture, high protein low carbohydrate diet and low caloric diet in people with Obesity, run by National Research Centre, Egypt at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Laser acupuncture, high protein low carbohydrate diet and low caloric diet
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- obese females of BMI more than 30 kg/m2, and
- of age range from 20 to 50 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Laser acupuncture, high protein low carbohydrate diet, low caloric diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureDevice
GaAlAs semiconductor diode Laser Phototherapy Device
high protein low carbohydrate dietBehavioural
A tailored high protein/low carbohydrate/low caloric diet
low caloric dietBehavioural
Tailored balanced low caloric diet
| Study group | Role | What they receive |
|---|---|---|
| laser | Active comparator | 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 Receives: Device: Laser acupuncture; Behavioral: low caloric diet |
| high protein low carbohydrate diet | Active comparator | Subjects will be instructed to take a tailored high protein/low carbohydrate/low caloric diet. Receives: Behavioral: high protein low carbohydrate diet |
| control | Sham comparator | 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 . Receives: Device: Laser acupuncture; Behavioral: low caloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 8 weeks
Secondary outcomes (1)
decrease cardiovascular risks
endothelial markers , serum insulin and insulin resistance changes from baseline.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: This was a topic for a thesis project where the topic was changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neveen H Abou El-Soud, Ph.D, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573961
- Sponsor's protocol ID
- NRCEgypt
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2015
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 11854119Soenen 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.
PubMed 22935440
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02573961
- Acronym / sponsor ID
- NRCEgypt
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This was a topic for a thesis project where the topic was changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laser | Active comparator | Device: Laser acupuncture, Behavioral: low caloric dietSubjects 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 comparator | Behavioral: high protein low carbohydrate dietSubjects will be instructed to take a tailored high protein/low carbohydrate/low caloric diet. |
| control | Sham comparator | Device: Laser acupuncture, Behavioral: low caloric dietSubjects 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 . |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obese females of BMI more than 30 kg/m2, and
- of age range from 20 to 50 years.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser acupunctureGaAlAs semiconductor diode Laser Phototherapy Device | Device | control, laser |
| high protein low carbohydrate dietA tailored high protein/low carbohydrate/low caloric diet | Behavioural | high protein low carbohydrate diet |
| low caloric dietTailored balanced low caloric diet | Behavioural | control, laser |
Primary outcome
weight loss
Time frame: 8 weeks
1 secondary outcome
decrease cardiovascular risks
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 11854119Ziccardi 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.
- Background: PubMed 22935440Soenen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neveen H Abou El-Soud, Ph.D principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture, high protein low carbohydrate diet and low caloric diet in people with Obesity, run by National Research Centre, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02573961, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.