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

NCT ID: NCT05980663

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2023-12-31

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 in obese participants with asthma.

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).

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.

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 phase). In subsequent stages, subjects gradually increase their energy intake and gradually substitute meal replacement product (MRP) with regular nutritionally profiled meals (active phase and maintenance phase). The final (stable) phase 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.

The study for the child population of respondents is designed in such a way that the respondents in the initial phase implement a low-calorie diet of about 1300-1500 kcal, whereby 3 daily meals are replaced with meal replacements in the reduction diet in addition to 2 nutritionally balanced regular meals that include a minimum of 5 daily servings of fruits and vegetables (active group and active control) (intensive phase).

In subsequent phases, subjects gradually increase their energy intake and gradually replace MRP with regular nutritionally profiled meals (active phase and stable phase). The final phase represents the phase in which subjects consume the usual meals designed by the nutritionists of Children's hospital Srebrnjak, where education and nutrition counseling is also carried out.

The usual meals of the later stages of the study, apart from being low in energy and highly nutritionally dense are composed in such a way that they are either ready for consumption as a complete meal (e.g. ready- to eat tuna salad) or can be quickly prepared. In this way, the test respondents are directed to an adequate diet, which, by adopting proper food and lifestyle habits, will ultimately enable them to maintain the achieved reduced body weight in the long term.

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.

200 participants in a ratio of 2:1:1 (adults and children)

• active group - 80
• active control (positive control group) - 80
• control group (negative control group) - 40

Adult participants program:

The daily energy intake is defined at around 1000-1100 kcal per day, and counseling on nutrition and physical activity is carried out.

1. Intensive phase(2-14 weeks) about 1000 - 1100 kcal/day 5 MRP (200-220 kcal per product) + 1 salad (20 kcal per portion) + water/unsweetened tea.

2. Active phase(14-21 weeks) 1100-1200 kcal/day 3 MRP (200-220 kcal per meal) + 2 regular meals (200-280 kcal) + water/unsweetened tea.

3. Maintenance phase (21-28 weeks): 1200-1500 kcal/day 2 MRP (200-220 kcal per meal) + 3 regular meals (260-350 kcal) + water/unsweetened tea

4. Stable phase (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.

Children participants program:

The daily energy intake is defined at around 1300-1500 kcal per day, and counseling on nutrition and physical activity is carried out.

1. Intensive phase children (weeks 2-14) around 1300-1500 kcal/day 3 MPR (200-220 kcal per product + 2 regular meals (320-400 kcal) + 1 or more salad (20 kcal per product)+ water/unsweetened tea.

2. Active phase children (14-21 weeks) around 140-1600kcal/day 2 MPR (200-220 kcal per product) + 3 regular meals (320-400 kcal) + water/unsweetened tea.

3. Maintenance phase (21-28 weeks): 1600-1900 kcal/day 1 MRP (200-220 kcal per meal) + 4 regular meals (350-420 kcal) + water/unsweetened tea

4. Stable phase children (week 28-40) 1750-2250 kcal/day. 5 regular meals (350-450 kcal) + water/unsweetened tea.

Snacks are included in regular meals, where the total value of meals and snacks does not exceed the total set value of regular meals.

Conditions

Obesity; Asthma; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active group

Participants use the innovative line of products intended for body weight reduction, that represent a meal replacement for weight management.

Group Type: EXPERIMENTAL

Meal replacement product- INNOVATIVE PRODUCT

Intervention Type: DIETARY_SUPPLEMENT

innovative product line contains raw materials that are considered better sources of potentially bioactive components

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).

Group Type: ACTIVE_COMPARATOR

Meal replacement product- STANDARD PRODUCT

Intervention Type: DIETARY_SUPPLEMENT

standard product line contains common ingredients and this type of product already exists on world markets

Control group

Participants receive personalized advice on proper nutrition for a reduction diet in which they use common food.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meal replacement product- STANDARD PRODUCT

standard product line contains common ingredients and this type of product already exists on world markets

Intervention Type: DIETARY_SUPPLEMENT

Meal replacement product- INNOVATIVE PRODUCT

innovative product line contains raw materials that are considered better sources of potentially bioactive components

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

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 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belupo

OTHER

Sponsor Role: collaborator

Podravka d.d.

UNKNOWN

Sponsor Role: collaborator

Children's Hospital Srebrnjak

OTHER

Sponsor Role: lead

Responsible Party

Mirjana Turkalj, MD

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital Srebrnjak

Zagreb, , Croatia

Site Status: RECRUITING

Countries

Croatia

Central Contacts

Mirjana Turkalj, Prof., MD

Role: CONTACT

mturkalj@bolnica-srebrnjak.hr

+38516391164

Facility Contacts

Mirjana Turkalj, MD, PhD

Role: primary

mturkalj@bolnica-srebrnjak.hr

+38516391164

Other Identifiers

KK.01.1.1.07.0075_2

Identifier Type: -

Identifier Source: org_study_id