Clinical Trials of Two Helichrysum Infusions in Adults (SMILJ)

September 28, 2021 updated by: Zala Jenko Praznikar, University of Primorska

Comparison of Helichrysum Italicum Infusion and Helichrysum Arenarium Infusion Effects on the Components of Metabolic Syndrome in Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Helichrysum arenarium (HA) has a long tradition in European ethno-medicine as a medicinal plant with many known activities; EU monograph supports its use for the digestive disorders, feeling of fullness and bloating, and, importantly, it re-ports no side effects. Assessment report of the European Medicines Agency Committee on Herbal Medicinal Products supports its stimulatory role in the bile flow and in the release of cholesterol to the bile. HA has also been used in chronic liver inflammatory disease and as a scavenger of free radicals. Similar to HA Helichrysum italicum (HI) is widely used in traditional medicine. Lately, much attention has been given to natural antioxidants and their ability to delay the progression of chronic diseases related to the formation and the activity of reactive oxygen species and other free radicals. Herbs are very often used to prepare recreational tea and are thereby important sources of antioxidants in different cultures. In traditional medicine, HI is also used in diet, mainly for the preparation of infusions in treating respiratory and digestive conditions.

Therefore,the ail of our study is to evaluate the effects of Helichrysum italicum and Helichrysum Arenarium 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 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Helichrysum italicum
1 g of milled plant material (Helichrysum italicum) immersed in hot water (200 mL, 100 °C) for 10minutes
Dietary supplement: Helichrysum italicum infusion
Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum italicum infusion.
Active Comparator: Helichrysum arenarium
1 g of milled plant material (Helichrysum arenarium) immersed in hot water (200 mL, 100 °C) for 10minutes
Dietary supplement: Helichrysum arenarium
Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum arenarium infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: changes from baseline to four weeks of daily consumption and after two weeks of washout
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: changes from baseline to four weeks of daily consumption and after two weeks of washout
Systolic and diastolic blood pressure will be determined with blood pressure device (Omron M3)
changes from baseline to four weeks of daily consumption and after two weeks of washout
Inflammation
Time Frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Changes in C-reactive protein levels will be examined with biochemical analyzer Cobass
Chages from baseline to four weeks of daily consumption and after two weeks of washout
Anthropometric measurements
Time Frame: Chages from baseline to four weeks of daily consumption and 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).
Chages from baseline to four weeks of daily consumption and after two weeks of washout
Microbiota
Time Frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
The microbiota composition will be determined with gene sequencing
Chages from baseline to four weeks of daily consumption and after two weeks of washout
Antioxidative potential
Time Frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Antioxidative potential will be determined with DPPH radical measuremen
Chages from baseline to four weeks of daily consumption and after two weeks of washout
Anthropometric measurements
Time Frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Changes in visceral fat rating will be examined with bioelectrical impedance analysis (BIA) Tanita MC-980MA (Maeno-cho, Japan) and dedicated software (GMON Pro-Tanita).
Chages from baseline to four weeks of daily consumption and after two weeks of washout
Anthropometric measurements Description:
Time Frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Changes in fat (percentage of body fat) will be examined with bioelectrical impedance analysis (BIA) Tanita MC-980MA (Maeno-cho, Japan) and dedicated software (GMON Pro-Tanita).
Chages from baseline to four weeks of daily consumption and after two weeks of washout

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Primorska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Actual)

June 3, 2021

Study Completion (Actual)

June 19, 2021

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMILJ_Clinical

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperglycemia

Clinical Trials on Helichrysum italicum infusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe