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

NCT05980663 | Unknown

• 1 other identifier: KK.01.1.1.07.0075_2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Asthma; Overweight

Keywords

obesity; asthma; overweight; nutrition

Outcome Measures

Primary Outcomes (1)

• 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).

  every 4 weeks, through study completition (up to 9 months)

Secondary Outcomes (5)

• Anthropometric measurements

  every 2 months, through study completition (up to 9 months)

• Lipid profile (triglycerides, total cholesterol, HDL, LDL)

  at 1st week of the study and after 3, 6 and 9 months, through study completition (up to 9 months)

• Questionnaire on quality of life

  at the beginning of the study (1st week) and at the end (40th week)

• Change of asthma control

  every 3 months, through study completition (up to 9 months)

• Change in the number of asthma exacerbations and severity

  every 3 months,through study completition (up to 9 months)

Study Arms (3)

Active group

EXPERIMENTAL

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- INNOVATIVE 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).

Dietary Supplement: Meal replacement product- STANDARD PRODUCT

Control group

NO INTERVENTION

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

Interventions

Meal replacement product- STANDARD PRODUCT DIETARY_SUPPLEMENT

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

Active control

Meal replacement product- INNOVATIVE PRODUCT DIETARY_SUPPLEMENT

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

Active group

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Srebrnjak: lead
• Belupo: collaborator
• Podravka d.d.: collaborator

Study Sites (1)

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Obesity; Asthma; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Mirjana Turkalj, Prof., MD

CONTACT

+38516391164; mturkalj@bolnica-srebrnjak.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: Randomized stratified controlled clinical study

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: August 8, 2023
• Study Start: January 17, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-07

Locations

CR (1)