A Feasibility Study Addressing the Frequency of Low Level Laser Therapy for Reducing Central Adiposity and Weight in Overweight Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Laser for 4 weeks
3 Low-Level Laser Therapy Treatments Weekly
干预措施: 3 Low-Level Laser Therapy Treatments Weekly (Device)
Laser for 6 weeks
2 Low-Level Laser Therapy Treatments Weekly
干预措施: 2 Low-Level Laser Therapy Treatments Weekly (Device)
Laser for 12 weeks
1 Low-Level Laser Therapy Treatment Weekly
干预措施: 1 Low-Level Laser Therapy Treatment Weekly (Device)
结局指标
主要结局
Change in Weight
时间窗: baseline and 4 weeks
Comparison of weight change from baseline between arms
Change in Waist Circumference
时间窗: baseline and 4 weeks
Comparison of waist circumference change from baseline between arms
次要结局
未报告次要终点