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

Comparison of VitalPLANT and Helichrysum Italicum Infusions Effects on the Components of Metabolic Syndrome in Adults

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Tea infusion VitalPLANT - Active comparator; Dietary supplement: Tea infusion VitalPLANT + Helichrysum Italicum - Experimental product

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Izola
    • Izola, Izola, Slovenia, 6310
      • University Of Primorska Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VitalPLANT; 0.75 g of milled plant material (VitalPLANT)	Dietary supplement: Tea infusion VitalPLANT - Active comparator; Consumation of 200 mL of tea infusion (VitalPLANT) in the morning 30 min before breakfast for one week
Experimental: VitalPLANT+Helichrysum Italicum; 0.75 g of milled plant material (VitalPLANT) + 0.75 g of milled Helichrysum Italicum	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measurements	Changes in body fat (in kilograms and %) 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
Lipid profile	Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides will be examined with biochemical analyzer Cobass	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 in C-reactive protein levels will be examined with biochemical analyzer Cobass	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 in glucose levels will be examined with biochemical analyzer Cobass	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

Collaborators and Investigators

• Sponsor: University of Primorska
• Collaborators: Institute of food technology Novi Sad; Josip Pančič Institute Belgrade
• Investigators: Principal Investigator: Zala Jenko Pražniakr, phD, University of Primorska, Faculty of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Actual): April 20, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: overweight; metabolic syndrome; functional food; tea infusion
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Metabolic Syndrome
• Other Study ID Numbers: VitalPLANT and SMILJ_clinical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No