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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06866314
Enrollment
30
Registered
2025-03-10
Start date
2025-03-15
Completion date
2025-07-01
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Overweight

Keywords

functional food, tea infusion, overweight, metabolic syndrome

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.

Interventions

DIETARY_SUPPLEMENTTea infusion VitalPLANT - Active comparator

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

DIETARY_SUPPLEMENTTea 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

Sponsors

Institute of food technology Novi Sad
CollaboratorUNKNOWN
Josip Pančič Institute Belgrade
CollaboratorUNKNOWN
University of Primorska
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Body weightchanges 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 washoutChanges 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

MeasureTime frameDescription
Anthropometric measurementschanges 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 washoutChanges 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).
Lipid profilechanges 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 washoutChanges in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides will be examined with biochemical analyzer Cobass
nflammationchanges 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 washoutChanges in C-reactive protein levels will be examined with biochemical analyzer Cobass
Glucose levelschanges 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 washoutChanges in glucose levels will be examined with biochemical analyzer Cobass

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026