Effect of Different Weight Vests on Body Weight in Obese Individuals
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
Obesity related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are major causes of death in the Western World. The proposed research may result in improved prevention, diagnosis and treatments of obesity and obesity-related disorders. Recently published data show that if a weight is carried by a rodent, this animal will lose body weight and gain an improved glucose control.
We aim to confirm these findings in a human model. We plan to let obese subjects carry weight vests and monitor their change in body weight. We will also measure appetite, physical activity and insulin sensitivity to further examine the potential beneficial effects of loading. Blood sampling will be performed to investigate the mechanism of action.
详细描述
STUDY OBJECTIVES AND ENDPOINTS
Primary objective
To determine if wearing a weight vest with 11 % of an individual's body weight for 3 weeks decreases body weight in obese study subjects.
Secondary objective
To determine if wearing a weight vest with 11 % of an individual's body weight for 3 weeks affects fat mass, bone mass, muscle mass, water mass, fat free mass, physical activity and food intake in obese study subjects.
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
- Single (Participant)
盲法说明
Masking will not be publically revealed before the study ends. Subjects may be able to determine if they are in the control/placebo group or intervention group if we publically reveal our masking procedure. However, the masking procedure is pre-determined and approved by the ethic's committee.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obesity as defined by a BMI >30 and ≤
- •Fat mass should be above 25 %.
- •18-70 years of age. We will primarily recruit men. Women will only be recruited if we are unable to find 80 eligible male participants.
- •Consent out of free will.
- •Willingness to comply with the study protocol and restrictions of not consuming excessive amounts of alcohol (maximum 1 litre, 11 % or alcohol equivalent for a full week) or using any drugs. Smoking and snuff use is allowed.
- •Normal screening blood- and urine samples. In blood: hemoglobin, white blood cells, trombocytes, sodium, potassium, creatinine, ASAT, ALAT, HbA1c, CRP, T4, TSH. In urine: nitrite, white blood cells, red blood cells, glucose, creatinine and albumin.
- •Signed informed consent.
排除标准
- •Chronic disease that hardens the participation in the study as judged by the investigator.
- •Chronic pain such as pain that is constant and impairs quality of life; for example: severe back, hip and knee pain.
- •Regular consumption of medicine or natural supplements that affect weight, inhibit physical activity or increase the risk of adverse effects as judged by the investigator. The following drugs will not be accepted: β-antagonists, GLP-1-agonists, SGLT2-inhibitors, sulfonylureas, insulin, orlistat, mysimba and bisphosphonates.
- •Gastric by-pass surgery or equivalent.
- •Reduced mobility.
- •Pregnancy: Females of childbearing potential must confirm to use reliable contraception and not suspect to be pregnant. Subjects may be asked to perform a pregnancy test.
- •Change in body weight of 5 kg or greater during the past 3 months or recently started a strict diet. Also, a greater change in body weight than 1.5 kg difference between day 1 and day 8 will not be accepted.
- •Drastic change in lifestyle during the last 3 months; for example a significant change in physical activity or nicotine, alcohol or drug use.
- •Apparent risk of not being able to comply with the study protocol for any reason as judged by the investigator.
研究组 & 干预措施
Intervention
Subjects in this arm will carry heavy weight vests for three weeks.
干预措施: Weight Vest (Device)
Control
Subjects in this arm will carry light weight vests for three weeks.
干预措施: Weight Vest (Device)
结局指标
主要结局
Body Weight
时间窗: 3 weeks
Change in body weight between start of the intervention and end of the intervention, indirectly measuring change in BMI
次要结局
- Appetite(3 weeks)
- Bone Mass(3 weeks)
- Physical Activity(3 weeks)
- Water Mass(3 weeks)
- Fat Mass(3 weeks)
- Muscle Mass(3 weeks)
- Metabolism(3 weeks)