NCT04866628

Brief Summary

The study evaluates the effects of Helichrysum italicum and Helichrysum Arenarium on different components of the metabolic syndrome. The components of metabolic syndrome will be measured at baseline and four weeks after daily consumptions of either Helichrysum italicum or either Helichrysum Arenarium, and after two weeks of washout. In addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either Helichrysum italicum or either Helichrysum Arenarium.

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 hypertension

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable hypertension

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

April 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

May 6, 2021

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

28 days

First QC Date

April 23, 2021

Last Update Submit

September 28, 2021

Conditions

HypertensionHyperlipidemiasInflammationHyperglycemiaHypercholesterolemiaMicrobial ColonizationOverweight and Obesity

Keywords

metabolic syndromeherbal infusionsdietmicrobiota

Outcome Measures

Primary Outcomes (1)

  • Lipid profile

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

    changes from baseline to four weeks of daily consumption and after two weeks of washout

Secondary Outcomes (7)

  • Blood pressure

    changes from baseline to four weeks of daily consumption and after two weeks of washout

  • Inflammation

    Chages from baseline to four weeks of daily consumption and after two weeks of washout

  • Anthropometric measurements

    Chages from baseline to four weeks of daily consumption and after two weeks of washout

  • Microbiota

    Chages from baseline to four weeks of daily consumption and after two weeks of washout

  • Antioxidative potential

    Chages from baseline to four weeks of daily consumption and after two weeks of washout

  • +2 more secondary outcomes

Study Arms (2)

Helichrysum italicum

EXPERIMENTAL

1 g of milled plant material (Helichrysum italicum) immersed in hot water (200 mL, 100 °C) for 10minutes

Dietary Supplement: Helichrysum italicum infusion

Helichrysum arenarium

ACTIVE COMPARATOR

1 g of milled plant material (Helichrysum arenarium) immersed in hot water (200 mL, 100 °C) for 10minutes

Dietary Supplement: Helichrysum arenarium

Interventions

Helichrysum italicum infusionDIETARY_SUPPLEMENT

Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum italicum infusion.

Helichrysum italicum
Helichrysum arenariumDIETARY_SUPPLEMENT

Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum arenarium infusion.

Helichrysum arenarium

Eligibility Criteria

Age40 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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, 6310, Slovenia

Location

Related Publications (3)

  • Pljevljakusic D, Bigovic D, Jankovic T, Jelacic S, Savikin K. Sandy Everlasting (Helichrysum arenarium (L.) Moench): Botanical, Chemical and Biological Properties. Front Plant Sci. 2018 Aug 7;9:1123. doi: 10.3389/fpls.2018.01123. eCollection 2018.

    PMID: 30131818BACKGROUND

  • Sala A, Recio M, Giner RM, Manez S, Tournier H, Schinella G, Rios JL. Anti-inflammatory and antioxidant properties of Helichrysum italicum. J Pharm Pharmacol. 2002 Mar;54(3):365-71. doi: 10.1211/0022357021778600.

    PMID: 11902802BACKGROUND

  • Kramberger K, Jenko Praznikar Z, Baruca Arbeiter A, Petelin A, Bandelj D, Kenig S. A Comparative Study of the Antioxidative Effects of Helichrysum italicum and Helichrysum arenarium Infusions. Antioxidants (Basel). 2021 Mar 3;10(3):380. doi: 10.3390/antiox10030380.

    PMID: 33802628BACKGROUND

MeSH Terms

Conditions

HypertensionHyperlipidemiasInflammationHyperglycemiaHypercholesterolemiaCommunicable DiseasesOverweightObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersInfectionsDisease AttributesOvernutritionNutrition DisordersBody WeightSigns and SymptomsInsulin ResistanceHyperinsulinism

Study Design

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

Study Record Dates

First Submitted

April 23, 2021

First Posted

April 30, 2021

Study Start

May 6, 2021

Primary Completion

June 3, 2021

Study Completion

June 19, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

SL(1)