Clinical Trials of VitalPLANT and Helichrysum Infusions in Adults ( VitalPlant_SMILJ )

NCT ID: NCT06866314

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-07-01

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.

Detailed Description

"VITALPLANT" medicinal plant mixture, aimed at body weight regulation and metabolism enhancement was formulated in order to be incorporated as an ingredient in functional food formulations on the basis of known biological activity of the alder buckthorn bark, peppermint, caraway and parsley. Medicinal plants have long been known as sources of biologically active substances.Oil component apiole - a proven kidney stimulant and parsley (Petroselinum crispum (Mill.) A.W. Nym. ex Hill) are known for their diuretic action. Peppermint (Mentha x piperita L.) and caraway (Carum Carvi L.) essential oils are frequently used in herbal drugs for treatment of abdominal discomfort and pain, while the alder buckthorn bark (Rhamnus Frangula L.) contains anthraquinone glycosides with purgative effects. "Vitalplant" mixture was found to be beneficial for the reduction of body weight and improvement of antioxidant status of the erythrocytes, and its antihyperlipidemic property was highly active for enhancing the profile of plasma lipids in rats.

Similarly, Helichrysum italicum (HI) is also widely used in traditional medicine. Lately, it has been shown that HI infusion consumption had a beneficial effect on anthropometric traits. Indeed, significant reductions in body weight, body mass index, and visceral and total body fat were observed in adults. Moreover, after four weeks of intervention, LDL decreased and serum antioxidant properties were improved. Therefore, consuming infusion could thus be recommended as a simple, profitable habit for individuals with traits of metabolic syndrome.

Therefore, the aim of our study is to evaluate the effects of VitalPLANT alone and VitalPlant+Helichrysum italicum on different components of the metabolic syndrome in adults presenting at least two components of metabolic syndrome and yet not receiving any medication. The components of metabolic syndrome (lipid profile, blood pressure, antrophometry, inflammation status, glucose levels) will be measured at baseline and one week after daily consumptions of either VitalPLANT alone or VitalPLANT+SMILJ. In between there will be one week of washout period.

Conditions

Overweight; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

VitalPLANT

0.75 g of milled plant material (VitalPLANT)

Group Type: ACTIVE_COMPARATOR

Tea infusion VitalPLANT - Active comparator

Intervention Type: DIETARY_SUPPLEMENT

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

VitalPLANT+Helichrysum Italicum

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

Group Type: EXPERIMENTAL

Tea infusion VitalPLANT + Helichrysum Italicum - Experimental product

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Tea infusion VitalPLANT - Active comparator

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

Intervention Type: DIETARY_SUPPLEMENT

Tea infusion VitalPLANT + Helichrysum Italicum - Experimental product

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of food technology Novi Sad

UNKNOWN

Sponsor Role: collaborator

Josip Pančič Institute Belgrade

UNKNOWN

Sponsor Role: collaborator

University of Primorska

OTHER

Sponsor Role: lead

Responsible Party

Zala Jenko Praznikar

Associate Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zala Jenko Pražniakr, phD

Role: PRINCIPAL_INVESTIGATOR

University of Primorska, Faculty of Health Sciences

Locations

University Of Primorska Faculty of Health Sciences

Izola, Izola, Slovenia

Countries

Slovenia

Other Identifiers

VitalPLANT and SMILJ_clinical

Identifier Type: -

Identifier Source: org_study_id