NCT05733871

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

January 17, 2023

Last Update Submit

February 8, 2023

Conditions

Overweight and ObesityBody Weight

Keywords

nutritionoverweightobesitydiet

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).

    After 40 weeks

Secondary Outcomes (3)

  • Anthropometric measurements

    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)

    at the beginning of the study and after 3, 6 and 9 months

  • Questionnaire on quality of life

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

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- 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).

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.

Interventions

meal replacement product- STANDARD PRODUCTDIETARY_SUPPLEMENT

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

Active group
Meal replacement product- INNOVATIVE PRODUCTDIETARY_SUPPLEMENT

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

Active control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adults aged 18-60
  • both sexes
  • BMI \>27 kg/m2
  • 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 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.
  • people with eating disorders (bulimia)
  • alcohol and drug addicts
  • pregnancy, breastfeeding
  • unstable thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

OverweightObesityBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mirjana Turkalj, Prof., MD

CONTACT

+38516391164mturkalj@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
Model Details: Randomized stratified controlled clinical study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 17, 2023

Study Start

January 17, 2023

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

CR(1)