Evaluation of the Effectiveness of Standard and Innovative Products That Represent a Substitute Meal for Weight Management in a Reduction Diet

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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). 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. The study for a group of adult participants was designed in such a way that the participants in the initial stage follow a low-calorie diet of about 1000 - 1100 kcal, whereby 5 daily meals are replaced with meal replacements in the reduction diet (active group and active control) (intensive stage). In subsequent stages, subjects gradually increase their energy intake and gradually substitute meal replacement product (MRP) with regular nutritionally profiled meals (active stage and maintenance stage). The final (stable) stage represents the stage in which, in addition to one meal replacement per day, the usual meals designed by the nutritionists of Belupo and the Culinary Center of Podravka are consumed, where education and nutrition counseling is also carried out. Study entry stage (0-2 weeks): subjects are recruited respecting the inclusion and exclusion criteria. Recruitment is carried out by a doctor. During this stage, subjects replace standard meals with meal replacement products and reduce energy intake to a final defined intake depending on the group of subjects. 36 participants in a ratio of 1:1:1 active group - 12 active control (positive control group) - 12 control group (negative control group) - 12 The daily energy intake is defined at around 1000-1100 kcal per day, and counseling on nutrition and physical activity is carried out. Intensive stage (2-14 weeks) about 1000 - 1100 kcal/day 5 MRP (200-220 kcal per product) + 1 salad (20 kcal per portion) + water/unsweetened tea. Active stage (14-21 weeks) 1100-1200 kcal/day 3 MRP (200-220 kcal per meal) + 2 regular meals (200-280 kcal) + water/unsweetened tea. Maintenance stage (21-28 weeks): 1200-1500 kcal/day 2 MRP (200-220 kcal per meal) + 3 regular meals (260-350 kcal) + water/unsweetened tea Stable stage (28-40 weeks): 1500-2000 kcal 1 MRP (200-220 kcal per meal) + 4 regular meals (approx. 320-450 kcal) + water/unsweetened tea Usual meals can also contain snacks with lower energy values, but it is important to consume approx. 1300-1800 kcal per day with usual foods.

Official Title
-----------------
Randomized Stratified Controlled Clinical Study for Evaluate the Effectiveness of a Diet Program Designed for Reduce Body Weight Using Standard and Innovative Products

Conditions
-----------------
Body Weight, Overweight and Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: meal replacement product- STANDARD PRODUCT
* Dietary Supplement: Meal replacement product- INNOVATIVE PRODUCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults aged 18-60 both sexes BMI >27 kg/m2 signed informed consent Exclusion Criteria: 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 went through an 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized stratified controlled clinical study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active group<br>Participants use the innovative line of products intended for body weight reduction, that represent a meal replacement for weight management | Dietary Supplement: meal replacement product- STANDARD PRODUCT<br>* standard product line contains common ingredients and this type of product already exists on world markets<br>|
| Active Comparator: Active control<br>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). | Dietary Supplement: Meal replacement product- INNOVATIVE PRODUCT<br>* innovative product line contains raw materials that are considered better sources of potentially bioactive components<br>|
| No Intervention: Control group<br>Participants receive personalized advice on proper nutrition for a reduction diet in which they use common food. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BM/FM | 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). | After 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measurements | Change in anthropometric measurements- waist and hip circumference and waist/hip ratio and waist/height ratio Measurements of participants' waist, hip and height in meters will be taken. This multiple measurements will be aggregated and presented in ratio waist [meter] / hip [meter] and ratio waist [meter] / height [meter] | measurements at each examination - every 2 weeks up to week 21 and every 4 weeks from week 21 to week 40 | 
| Lipid profile (triglycerides, total cholesterol, HDL, LDL) | Change of the cholesterol test/lipid panel/lipid profile (change in HDL/LDL ratio) compared to initial values | at the beginning of the study and after 3, 6 and 9 months | 
| Questionnaire on quality of life | The questionnaire consists of descriptive system and visual analogue scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The visual analogue scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The questionnaire is in Croatian language, with a valid and accurate translation of the corresponding original document. | at the beginning of the study (1st week) and at the end (40th week) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition, overweight, obesity, diet