Status:
UNKNOWN
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
Lead Sponsor:
Children's Hospital Srebrnjak
Collaborating Sponsors:
Belupo
Podravka d.d.
Conditions:
Obesity
Asthma
Eligibility:
All Genders
12-60 years
Phase:
NA
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...
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 predisposition...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05980663
Start Date
January 17 2023
End Date
December 1 2023
Last Update
August 8 2023
Active Locations (1)
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1
Children's Hospital Srebrnjak
Zagreb, Croatia, 10000