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Completed

NCT Number: NCT06866314

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

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Primorska Faculty of Health Sciences

Izola, Municipality of Izola, 6310, Slovenia

About this study

"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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tea infusion VitalPLANT - Active comparator

Dietary Supplement

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

Tea infusion VitalPLANT + Helichrysum Italicum - Experimental product

Dietary Supplement

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

Primary outcomes

  1. Body weight

    Time frame: 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

    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)

Secondary outcomes

  1. Anthropometric measurements

    Time frame: 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

    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).

  2. Lipid profile

    Time frame: 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

    Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides will be examined with biochemical analyzer Cobass

  3. nflammation

    Time frame: 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

    Changes in C-reactive protein levels will be examined with biochemical analyzer Cobass

  4. Glucose levels

    Time frame: 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

    Changes in glucose levels will be examined with biochemical analyzer Cobass

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Collaborators

  • Institute of food technology Novi Sad
  • Josip Pančič Institute Belgrade

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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