NCT02877004

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 13, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

August 17, 2016

Results QC Date

August 12, 2019

Last Update Submit

September 9, 2019

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (2)

  • Change in Weight

    Comparison of weight change from baseline between arms

    baseline and 4 weeks

  • Change in Waist Circumference

    Comparison of waist circumference change from baseline between arms

    baseline and 4 weeks

Study Arms (3)

Laser for 4 weeks

ACTIVE COMPARATOR

3 Low-Level Laser Therapy Treatments Weekly

Device: 3 Low-Level Laser Therapy Treatments Weekly

Laser for 6 weeks

ACTIVE COMPARATOR

2 Low-Level Laser Therapy Treatments Weekly

Device: 2 Low-Level Laser Therapy Treatments Weekly

Laser for 12 weeks

ACTIVE COMPARATOR

1 Low-Level Laser Therapy Treatment Weekly

Device: 1 Low-Level Laser Therapy Treatment Weekly

Interventions

3 Low-Level Laser Therapy Treatments WeeklyDEVICE

Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks

Laser 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

Laser for 6 weeks
1 Low-Level Laser Therapy Treatment WeeklyDEVICE

Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks

Laser for 12 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 31473867RESULT

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Ivana Croghan
Organization
Mayo Clinic
nicotineresearch@mayo.edu
507-266-1944

Study Officials

  • Ivana T Croghan, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 24, 2016

Study Start

September 30, 2016

Primary Completion

July 28, 2018

Study Completion

August 28, 2018

Last Updated

September 13, 2019

Results First Posted

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)