Weight LossLLLTNCT02877004

LLLT for Reducing Waste Circumference and Weight

A study testing 3 Low-Level Laser Therapy Treatments Weekly, 2 Low-Level Laser Therapy Treatments Weekly and 1 Low-Level Laser Therapy Treatment Weekly in people with Weight Loss, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research is to gather preliminary information on the effectiveness of Low Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central body region. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Weight Loss
What is being tested?: 3 Low-Level Laser Therapy Treatments Weekly, 2 Low-Level Laser Therapy Treatments Weekly and 1 Low-Level Laser Therapy Treatment Weekly
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 30 Sep 2016to 28 Aug 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

over 18 years of age;
body weight of greater than 50 kg (110 pounds);
BMI between 25-29.9 kg/m2;
able to participate fully in all aspects of the study
understood and signed study informed consent

Who cannot join

used weight loss medications or participated in a weight loss program within past 30 days
currently taking supplements known to affect weight (garcinia cambogia, etc.)
weight fluctuations of 20 pounds or more in the past 6 months
implanted device (including pacemaker or lap band) in the targeted area of LLLT
known active eating disorder
known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression)

Show all 18Show fewer

used an investigational drug within 30 days of study enrollment
currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the medication phase and unwilling to use a reliable form of contraception
history of any major cardiovascular events
current uncontrolled hypertension
clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease
Prior surgical intervention for body sculpting/weight loss
medical, physical, or other contraindications for body sculpting/weight loss
any medical condition known to affect weight levels or to cause bloating or swelling
diagnosis of, and/or taking medication for, irritable bowel syndrome
active infection, wound or other external trauma to the areas to be treated with the laser
known photosensitivity disorder;
current active cancer or currently receiving treatment for or within 1 year of cancer remission

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Feasibility Study Addressing the Frequency of Low Level Laser Therapy for Reducing Central Adiposity and Weight in Overweight Individuals

The purpose of this research is to gather preliminary information on the effectiveness of Low Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central body region.

Read the detailed description

This will be an open label clinical trial with all study participants receiving LLLT. Preliminary data will be collected on the efficacy of LLLT based on varying frequency of treatments. The focus of this study on 60 overweight adults with a BMI of 25 to 29.9, and assess changes in weight and waist circumference at end of treatment for group 1 (week 4) and group 2 (week 6) and group 3 (week 12). Participants will be randomized to receive LLLT treatments either 3 times a week; 2 times a week; or once a week.

Conditions: Weight Loss
Being tested: 3 Low-Level Laser Therapy Treatments Weekly, 2 Low-Level Laser Therapy Treatments Weekly, 1 Low-Level Laser Therapy Treatment Weekly
Medical subject headings: Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3 Low-Level Laser Therapy Treatments WeeklyDevice
Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks
2 Low-Level Laser Therapy Treatments WeeklyDevice
Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks
1 Low-Level Laser Therapy Treatment WeeklyDevice
Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks

Study groups in NCT02877004
Study group	Role	What they receive
Laser for 4 weeks	Active comparator	3 Low-Level Laser Therapy Treatments Weekly Receives: Device: 3 Low-Level Laser Therapy Treatments Weekly
Laser for 6 weeks	Active comparator	2 Low-Level Laser Therapy Treatments Weekly Receives: Device: 2 Low-Level Laser Therapy Treatments Weekly
Laser for 12 weeks	Active comparator	1 Low-Level Laser Therapy Treatment Weekly Receives: Device: 1 Low-Level Laser Therapy Treatment Weekly

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Weight
Comparison of weight change from baseline between arms
Measured: baseline and 4 weeks
Change in Waist Circumference
Comparison of waist circumference change from baseline between arms
Measured: baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 201628 Aug 2018

First posted24 Aug 2016 (estimated)
Study start30 Sep 2016
Primary completion28 Jul 2018
Study completion28 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Weight LossStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
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: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02877004
Sponsor's protocol ID: 16-004817
Acronym: LLLT
Status last verified: Sep 2019
First submitted: 17 Aug 2016
Last updated: 13 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Croghan IT, Hurt RT, Schroeder DR, Fokken SC, Jensen MD, Clark MM, Ebbert JO. Low-level laser therapy for weight reduction: a randomized pilot study. Lasers Med Sci. 2020 Apr;35(3):663-675. doi: 10.1007/s10103-019-02867-5. Epub 2019 Aug 31.
PubMed 31473867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
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RecruitingPhase 2
Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss
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All Weight Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study Addressing the Frequency of Low Level Laser Therapy for Reducing Central Adiposity and Weight in Overweight Individuals
ClinicalTrials.gov ID: NCT02877004
Acronym / sponsor ID: LLLT / 16-004817
Conditions: Weight Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 30 Sep 2016 (actual)
Primary completion: 28 Jul 2018 (actual)
Study completion: 28 Aug 2018 (actual)
First posted: 24 Aug 2016 (estimated)
Results: Posted 13 Sep 2019

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 research is to gather preliminary information on the effectiveness of Low Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central body region.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Laser for 4 weeks	Active comparator	Device: 3 Low-Level Laser Therapy Treatments Weekly3 Low-Level Laser Therapy Treatments Weekly
Laser for 6 weeks	Active comparator	Device: 2 Low-Level Laser Therapy Treatments Weekly2 Low-Level Laser Therapy Treatments Weekly
Laser for 12 weeks	Active comparator	Device: 1 Low-Level Laser Therapy Treatment Weekly1 Low-Level Laser Therapy Treatment Weekly

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

over 18 years of age;
body weight of greater than 50 kg (110 pounds);
BMI between 25-29.9 kg/m2;
able to participate fully in all aspects of the study
understood and signed study informed consent

Key exclusion criteria (18 listed)

used weight loss medications or participated in a weight loss program within past 30 days
currently taking supplements known to affect weight (garcinia cambogia, etc.)
weight fluctuations of 20 pounds or more in the past 6 months
implanted device (including pacemaker or lap band) in the targeted area of LLLT
known active eating disorder

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
3 Low-Level Laser Therapy Treatments WeeklyReceives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks	Device	Laser for 4 weeks
2 Low-Level Laser Therapy Treatments WeeklyReceives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks	Device	Laser for 6 weeks
1 Low-Level Laser Therapy Treatment WeeklyReceive 12 LLLT treatments - at a frequency of once per week for 12 weeks	Device	Laser for 12 weeks

Primary outcome

Change in Weight
Time frame: baseline and 4 weeks
Comparison of weight change from baseline between arms
Change in Waist Circumference
Time frame: baseline and 4 weeks
Comparison of waist circumference change from baseline between arms

Results and safety

Results posted to the registry on 13 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Laser for 4 Weeks	20	20
Laser for 6 Weeks	20	20
Laser for 12 Weeks	20	19

Primary outcome: Change in Weight

Time frame: baseline and 4 weeks. Mean (Standard Deviation). Unit: Kg

Measure	Laser for 4 Weeks n = 20	Laser for 6 Weeks n = 20	Laser for 12 Weeks n = 20
Value	-0.5 (1.7)	-0.9 (1.7)	-0.6 (1.5)

Laser for 4 Weeks vs Laser for 6 Weeks vs Laser for 12 Weeks: p = 0.723, ANCOVA

Primary outcome: Change in Waist Circumference

Time frame: baseline and 4 weeks. Mean (Standard Deviation). Unit: cm

Measure	Laser for 4 Weeks n = 20	Laser for 6 Weeks n = 20	Laser for 12 Weeks n = 20
Value	-1.4 (2.3)	-2.0 (2.5)	-0.8 (2.6)

Laser for 4 Weeks vs Laser for 6 Weeks vs Laser for 12 Weeks: p = .368, ANCOVA

Adverse events

Time frame: Adverse events were collected during LLLT treatment for each group (4 weeks for group A; 6 weeks for group B; 12 weeks for group C).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laser for 4 Weeks	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Laser for 6 Weeks	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Laser for 12 Weeks	1 of 20 (5%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31473867Croghan IT, Hurt RT, Schroeder DR, Fokken SC, Jensen MD, Clark MM, Ebbert JO. Low-level laser therapy for weight reduction: a randomized pilot study. Lasers Med Sci. 2020 Apr;35(3):663-675. doi: 10.1007/s10103-019-02867-5. Epub 2019 Aug 31.
Individual participant dataSharing planned: No

Related trials for Weight Loss

Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
Not yet recruitingPhase 1/2
Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Obesity & Overweight
Recruiting
OverStitch NXT Endoscopic Suture System
Weight Loss
Recruiting
Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
Weight Loss
RecruitingPhase 2
Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss
Overweight , Obesity, Adults

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.

Ivana T Croghan, PhD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 18 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: finished, as of the sponsor's last update on 13 Sep 2019. 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 United States. 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. 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?

Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Weight (time frame: baseline and 4 weeks). The study lists 2 primary outcomes in all. 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 NCT02877004, which also lists 1 linked publication.

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 13 Sep 2019.