Randomized Stratified Controlled Clinical Study for Evaluating the Effectiveness of a Diet Program Designed for Reducing Body Weight Using Standard and Innovative Products in Obese Participants With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- BM/FM
研究概览
简要总结
Randomized stratified controlled clinical study for evaluate the effectiveness of a diet program designed for reduce body weight through standard and innovative products that are a substitute meal for weight management in a reduction diet in obese participants with asthma.
详细描述
In the last few decades, there has been an increase in the number of obese people to the level of a global epidemic as a result of inadequate diet, sedentary lifestyle, but also genetic predispositions. The World Health Organization (WHO) declared obesity to be the biggest, global, chronic health problem in adults, that is increasingly becoming a more serious problem than malnutrition.On the other hand, obesity is a risk factor for the development of contemporary non-infectious diseases today that account for more than 80% of mortality in developed countries, such as vascular disease, diabetes and respiratory diseases such as asthma.
This trend is also recorded in Croatia, both in adult population and in children if the data from 2003 and 2015 are being compared, while according to data from 2019, almost two thirds of the adult population in Croatia were overweight or obese (42% overweight, 23% obese).
Of particular concern are the data from the European Obesity Monitoring Initiative from 2018/2019. according to which in Croatia 35% of children aged 8.0 to 8.9 were overweight or obese. At the national level, the problem of obesity is greater in boys than in girls, and it is 17.8% compared to 11.9% of girls. Croatia is in a high fifth place together with other countries of the Mediterranean region of Europe due to the shift from the Mediterranean to the Western lifestyle.
In cooperation with Podravka, Belupo has developed a standard and innovative product line. Products are replacing one or more one or more daily meals, and thay must comply with Regulation 2016/1413 requirements related to energy value, content and composition of fats and proteins, the amount of vitamins and minerals in this type of products.
The standard product line contains common ingredients and this type of product already exists on world markets, while the innovative product line differs from the standard one by implementing raw materials that are considered better sources of potentially bioactive components.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged 18-60, children aged 12-18
- •both sexes
- •BMI >27 kg/m2 (adults); > 90th centile for BMI (children)
- •clinical diagnosis of asthma
- •signed informed consent
排除标准
- •significant comorbidities: uncontrolled diabetes mellitus requiring insulin therapy and other endocrine disorders, cardiovascular disorders and other chronic diseases (including malignancies), chronic inflammatory diseases of the gastrointestinal tract, mental disorder
- •people who are currently on or have recently gone through a weight loss program (in the past 3 months)
- •people who in the past 6 months had an unwanted and uncontrolled loss of body weight >5%
- •people who underwent bariatric surgery in the past 6 months.
- •people using drugs that increase or decrease appetite
- •permanent therapy with steroid drugs, antidepressants, cytostatics, hormone therapy, beta-blockers, etc.
- •people with eating disorders (bulimia)
- •alcohol and drug addicts
- •pregnancy, breastfeeding
- •unstable thyroid disease
研究组 & 干预措施
Active group
Participants use the innovative line of products intended for body weight reduction, that represent a meal replacement for weight management.
干预措施: Meal replacement product- INNOVATIVE PRODUCT (Dietary Supplement)
Active control
Participants use the standard line of products intended for weight reduction that represent a meal replacement for weight management with already proven clinical effectiveness (positive control).
干预措施: Meal replacement product- STANDARD PRODUCT (Dietary Supplement)
Control group
Participants receive personalized advice on proper nutrition for a reduction diet in which they use common food.
结局指标
主要结局
BM/FM
时间窗: every 4 weeks, through study completition (up to 9 months)
To determine the effectiveness of a weight change diet program based on an innovative and standard product line through actual reduction of the body mass (BM) / fat mass (FM) of the participants in relation to their pre - trial body mass(BM)/fat mass (FM).
次要结局
- Anthropometric measurements(every 2 months, through study completition (up to 9 months))
- Change of asthma control(every 3 months, through study completition (up to 9 months))
- Lipid profile (triglycerides, total cholesterol, HDL, LDL)(at 1st week of the study and after 3, 6 and 9 months, through study completition (up to 9 months))
- Questionnaire on quality of life(at the beginning of the study (1st week) and at the end (40th week))
- Change in the number of asthma exacerbations and severity(every 3 months,through study completition (up to 9 months))
研究者
Mirjana Turkalj, MD
Professor, MD, PhD
Children's Hospital Srebrnjak