Evaluating meal substitutes for weight management in obese individuals with asthma
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
This study is testing if using meal replacements can help obese adults and children with asthma lose weight and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 12 Years to 60 Years |
| Sex | All |
| Sponsor | Children's Hospital Srebrnjak Academic / other |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT05980663 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of a diet program utilizing both standard and innovative meal replacement products to aid weight management in obese participants diagnosed with asthma. The study will involve a randomized controlled design, focusing on adults and children who meet specific BMI criteria and have a clinical diagnosis of asthma. Participants will be monitored for weight reduction and overall health improvements while adhering to the meal replacement regimen. The trial seeks to address the growing obesity epidemic and its associated health risks, particularly in the context of respiratory diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 and children aged 12-18 with a BMI greater than 27 kg/m2 and a clinical diagnosis of asthma.
Not a fit: Patients with significant comorbidities, recent weight loss programs, or those on specific medications that affect appetite may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective dietary intervention for obese patients with asthma, potentially improving their overall health and quality of life.
How similar studies have performed: Other studies have shown promise in using meal replacements for weight management, but this specific approach targeting obese individuals with asthma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zagreb
- Children's Hospital Srebrnjak — Zagreb, Croatia (Recruiting)
Study contacts
- Study coordinator: Mirjana Turkalj, Prof., MD
- Email: mturkalj@bolnica-srebrnjak.hr
- Phone: +38516391164
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.