Overweight and ObesityNCT05733871
Evaluation of the Effectiveness of Standard and Innovative Products That Represent a Substitute Meal for Weight Management in a Reduction Diet
A study testing meal replacement product- STANDARD PRODUCT and Meal replacement product- INNOVATIVE PRODUCT in people with Overweight and Obesity and Body Weight, run by Children's Hospital Srebrnjak at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight and Obesity, Body Weight
- What is being tested?
- meal replacement product- STANDARD PRODUCT and Meal replacement product- INNOVATIVE PRODUCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCroatia
- Study dates
- 17 Jan 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adults aged 18-60
- both sexes
- BMI >27 kg/m2
- signed informed consent
Who cannot join
- 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.
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- people with eating disorders (bulimia)
- alcohol and drug addicts
- pregnancy, breastfeeding
- unstable thyroid disease
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Children's Hospital Srebrnjak
Zagreb, 10000
Mirjana Turkalj, MD, PhD, +38516391164, mturkalj@bolnica-srebrnjak.hr
Mirjana Turkalj, Prof,MD, PhD
About this study
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
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.
Read the 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.
- Conditions
- Overweight and Obesity, Body Weight
- Being tested
- meal replacement product- STANDARD PRODUCT, Meal replacement product- INNOVATIVE PRODUCT
- Keywords
- nutrition, overweight, obesity, diet
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meal replacement product- STANDARD PRODUCTDietary supplement
standard product line contains common ingredients and this type of product already exists on world markets
Meal replacement product- INNOVATIVE PRODUCTDietary supplement
innovative product line contains raw materials that are considered better sources of potentially bioactive components
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Participants use the innovative line of products intended for body weight reduction, that represent a meal replacement for weight management Receives: Dietary Supplement: meal replacement product- STANDARD PRODUCT |
| Active control | Active comparator | 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). Receives: Dietary Supplement: Meal replacement product- INNOVATIVE PRODUCT |
| Control group | No intervention | Participants receive personalized advice on proper nutrition for a reduction diet in which they use common food. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After 40 weeks
Secondary outcomes (3)
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]
Measured: 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
Measured: 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.
Measured: at the beginning of the study (1st week) and at the end (40th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start17 Jan 2023
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized stratified controlled clinical study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Srebrnjak
- Sponsor type
- University, hospital or other
- Collaborators
- Belupo, Podravka d.d.
- Responsible party
- Principal investigator, Mirjana Turkalj, MD, Children's Hospital Srebrnjak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733871
- Sponsor's protocol ID
- KK.01.1.1.07.0075_1
- Status last verified
- Feb 2023
- First submitted
- 17 Jan 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05733871
- Acronym / sponsor ID
- KK.01.1.1.07.0075_1
- Conditions
- Overweight and Obesity, Body Weight
- Keywords
- nutrition, overweight, obesity, diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Children's Hospital SrebrnjakUniversity, hospital or other
- Collaborators
- Belupo, Podravka d.d.
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Randomized stratified controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Dietary Supplement: meal replacement product- STANDARD PRODUCTParticipants use the innovative line of products intended for body weight reduction, that represent a meal replacement for weight management |
| Active control | Active comparator | Dietary Supplement: Meal replacement product- INNOVATIVE PRODUCTParticipants 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). |
| Control group | No intervention | –Participants receive personalized advice on proper nutrition for a reduction diet in which they use common food. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adults aged 18-60
- both sexes
- BMI >27 kg/m2
- signed informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meal replacement product- STANDARD PRODUCTstandard product line contains common ingredients and this type of product already exists on world markets | Dietary supplement | Active group |
| Meal replacement product- INNOVATIVE PRODUCTinnovative product line contains raw materials that are considered better sources of potentially bioactive components | Dietary supplement | Active control |
Primary outcome
BM/FM
Time frame: After 40 weeks
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).
3 secondary outcomes
Anthropometric measurements
Time frame: 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)
Time frame: at the beginning of the study and after 3, 6 and 9 months
Questionnaire on quality of life
Time frame: at the beginning of the study (1st week) and at the end (40th week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meal replacement product- STANDARD PRODUCT and Meal replacement product- INNOVATIVE PRODUCT in people with Overweight and Obesity and Body Weight, run by Children's Hospital Srebrnjak at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mirjana Turkalj, Prof., MD (+38516391164, mturkalj@bolnica-srebrnjak.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BM/FM (time frame: After 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.