NCT06866314

Brief Summary

The study evaluates the effects of VitalPLANT and Helichrysum italicum on different components of the metabolic syndrome. The components of metabolic syndrome will be measured at baseline and one week after daily consumption of either VitalPLANT alone or either VitalPLANT+Helichrysum italicum after one week of washout.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

March 4, 2025

Last Update Submit

January 14, 2026

Conditions

OverweightMetabolic Syndrome

Keywords

functional foodtea infusionoverweightmetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Changes in body weight (in kilograms) will be examined with bioelectrical impedance analysis (BIA) Tanita MC-980MA (Maeno-cho, Japan) and dedicated software (GMON Pro-Tanita)

    changes from baseline to one week of daily consumption of VitalPLANT alone, after one week washout and after one week of daily consumption of VitalPLANT+SMILJand after two weeks of washout

Secondary Outcomes (4)

  • Anthropometric measurements

    changes from baseline to one week of daily consumption of VitalPLANT alone, after one week washout and after one week of daily consumption of VitalPLANT+SMILJand after two weeks of washout

  • Lipid profile

    changes from baseline to one week of daily consumption of VitalPLANT alone, after one week washout and after one week of daily consumption of VitalPLANT+SMILJand after two weeks of washout

  • nflammation

    changes from baseline to one week of daily consumption of VitalPLANT alone, after one week washout and after one week of daily consumption of VitalPLANT+SMILJand after two weeks of washout

  • Glucose levels

    changes from baseline to one week of daily consumption of VitalPLANT alone, after one week washout and after one week of daily consumption of VitalPLANT+SMILJand after two weeks of washout

Study Arms (2)

VitalPLANT

ACTIVE COMPARATOR

0.75 g of milled plant material (VitalPLANT)

Dietary Supplement: Tea infusion VitalPLANT - Active comparator

VitalPLANT+Helichrysum Italicum

EXPERIMENTAL

0.75 g of milled plant material (VitalPLANT) + 0.75 g of milled Helichrysum Italicum

Dietary Supplement: Tea infusion VitalPLANT + Helichrysum Italicum - Experimental product

Interventions

Tea infusion VitalPLANT + Helichrysum Italicum - Experimental productDIETARY_SUPPLEMENT

Consumation of 200 mL of tea infusion VitalPLANT + Helichrysum Italicum in the morning 30 min before breakfast for one week

VitalPLANT+Helichrysum Italicum
Tea infusion VitalPLANT - Active comparatorDIETARY_SUPPLEMENT

Consumation of 200 mL of tea infusion (VitalPLANT) in the morning 30 min before breakfast for one week

VitalPLANT

Eligibility Criteria

Age40 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • stable weight in the last 3 months
  • BMI more than 25
  • clinical diagnosis of at least two components of metabolic syndrome

You may not qualify if:

  • consumption of dietary supplements
  • medications for any component of metabolic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Primorska Faculty of Health Sciences

Izola, Municipality of Izola, 6310, Slovenia

Location

MeSH Terms

Conditions

OverweightMetabolic Syndrome

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Zala Jenko Pražniakr, phD

    University of Primorska, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, PhD

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

March 15, 2025

Primary Completion

April 20, 2025

Study Completion

July 1, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)