Effect of Artificial Loading, Through Application of Weight Vests, on Body Weight in Obese Subjects; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in body weight at 5 weeks
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. This trial may result in improved prevention, diagnosis and treatments for obesity and obesity-related disorders. Published data show that if a weight is carried by a rodent, this animal will lose body weight and gain an improved glucose control. Recently published data further show comparable results in humans when carrying an additional weight.
The investigators aim to confirm and further investigate these findings in humans. The investigators plan to let obese participants carry weight vests and monitor their change in body weight. The investigators will also measure food intake, physical activity, energy expenditure, body composition, abdominal fat and heart rate variability. This to further examine the potential beneficial effects of loading and the mechanism of action.
详细描述
STUDY OBJECTIVES AND ENDPOINTS
Primary objective
To determine if wearing a weight vest with 11 percent of body weight for 8 hours/day for 5 weeks decreases body weight in obese subjects.
Secondary objectives
To determine if wearing a weight vest with 11 percent of an individual's body weight for up to 5 weeks affects levels of abdominal fat, liver fat, fat mass, fat free mass, physical activity, energy expenditure, waist circumference, food intake or activity in the autonomic nervous system in obese 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 (Outcomes Assessor)
盲法说明
Subjects might be able to determine if they are in the control group or intervention group since it is difficult to mask the difference between a heavy and a light weight vest. Therefore, intervention in this study won't be masked for the participants. However, group affiliation will be masked for outcomes assessors.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent to participate in the study.
- •Consent out of free will.
- •18-65 years of age.
- •Obesity as defined by a BMI >30 and ≤
- •Fat mass > 25 %.
- •Willingness to comply with the study protocol
- •Normal or clinically non-significant screening of blood samples:
- •Hemoglobin (Hb), White Blood Cell Count (WBC), thrombocyte count, sodium (Na), potassium (K), chloride (Cl), calcium (Ca), creatinine, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin, Prothrombin Time (PT-INR), Activated Partial Thromboplastin Time (APTT), human immunodeficiency viruses (HIV), Hepatitis B, Hepatitis C, glycated hemoglobin (HbA1c), C-reactive protein (CRP), free thyroxine (fT4), thyroid-stimulating hormone (TSH).
- •Normal or clinically non-significant aberrations of screening blood samples are defined as:
- •i. Normal: Values within the reference interval supplied by the local lab at Sahlgrenska University Hospital
- •ii. Clinically non-significant aberration: as judged by investigator (Clinical significance judged by investigator)
- •Normal or non-clinically significant 12-lead electrocardiography (ECG) recording as judged by the investigator.
排除标准
- •Chronic disease that could interfere with the participation in the study as judged by the investigator. For example poorly regulated type 1 or 2 diabetes, severe cardiovascular disease that effect daily life, severe pulmonary disease that affects daily life or malignancy.
- •Chronic pain such as pain that is constant and impairs quality of life as judged by the investigator; for example: significant 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-blockers, Glucagon-like peptide-1 (GLP-1) agonists, Dipeptidyl peptidase-4 (DPP-IV) inhibitors, SGLT2-inhibitors, sulfonylureas, insulin, orlistat, anti-obesity drugs, antidepressants, bisphosphonates, β2-agonists, oral corticosteroids, diuretics, benzodiazepines, or central nervous system stimulating drugs such as methylphenidate or dextroamphetamine.
- •Any illegal drugs according to local laws and regulation
- •Gastric by-pass surgery or equivalent metabolic surgery in the gastrointestinal tract.
- •Reduced mobility.
- •Pregnancy. Females of childbearing potential must confirm to use reliable contraception (intrauterine device, oral contraceptives or condom) and not suspect to be pregnant. Pregnancy test will be taken on all female subjects of fertile age unless permanently sterile, as judged by the investigator. Permanently sterile women can be excluded from the pregnancy test. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy
- •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 4 kg difference between day -21 and day 0 will not be accepted.
- •Use of any illegal drugs according to local regulations or consuming excessive amounts of alcohol, tobacco, nicotine.
- •a. Excessive amounts of above-mentioned substances defined as:
- •i. Consumption of more than 9 glasses of wine for women, 14 glasses of wine for men (15 cl/glass 11 % alcohol) or equivalent as judged by investigator during an ordinary week will not be accepted.
- •ii. Individuals with a consumption equal or higher than 10 cigarettes or half a packet of snuff per day.
- •Drastic change in lifestyle during the last 3 months; for example a significant change in physical activity, dietary habits, nicotine, alcohol or drug use as judged by the investigator.
- •Apparent risk of not being able to comply with the study protocol for any reason as judged by the investigator.
- •Having participated in a similar study during the last 6 months.
结局指标
主要结局
Change in body weight at 5 weeks
时间窗: 35 days
Change in body weight (in percent of baseline body weight) between day 35 and baseline in the high load group compared with low load group.
次要结局
- Change in waist circumference at 35 days(35 days)
- Change in physical activity at 21 days(21 days)
- Change in visceral fat at 35 days(35 days)
- Change in subcutaneous fat at 35 days(35 days)
- Change in body composition at 35 days(35 days)
- Change in energy expenditure at 28 days(28 days)
- Change in body weight at 15 days(15 days)
- Change in liver fat at 35 days(35 days)
- Change in autonomic nervous system activity at 15 days(15 days)
- Change in food intake at 28 days(28 days)