Clinical Trials of Two Helichrysum Infusions in Adults (SMILJ)

• ClinicalTrials.gov Identifier: NCT04866628
• Recruitment Status: Completed
• First Posted: April 30, 2021
• Last Update Posted: September 29, 2021
• Sponsor: University of Primorska
• Information provided by (Responsible Party): Zala Jenko Praznikar, University of Primorska

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Hyperlipidemias; Inflammation; Hyperglycemia; Hypercholesterolemia; Microbial Colonization; Overweight and Obesity	Dietary Supplement: Helichrysum italicum infusion; Dietary Supplement: Helichrysum arenarium	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Comparison of Helichrysum Italicum Infusion and Helichrysum Arenarium Infusion Effects on the Components of Metabolic Syndrome in Adults
• Actual Study Start Date: May 6, 2021
• Actual Primary Completion Date: June 3, 2021
• Actual Study Completion Date: June 19, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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)
2. 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
3. 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).
4. 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
5. 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
6. 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).
7. 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).

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Slovenia

University of Primorska, Faculty of Health Sciences

Izola, Slovenia, 6310

Sponsors and Collaborators

University of Primorska

More Information

Publications:

Pljevljakušić D, Bigović D, Janković T, Jelačić S, Šavikin 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. Review.

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

Kramberger K, Jenko Pražnikar 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). pii: 380. doi: 10.3390/antiox10030380.

• Responsible Party: Zala Jenko Praznikar, Associate professor, University of Primorska
• ClinicalTrials.gov Identifier: NCT04866628
• Other Study ID Numbers: SMILJ_Clinical
• First Posted: April 30, 2021
• Last Update Posted: September 29, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zala Jenko Praznikar, University of Primorska:

metabolic syndrome; herbal infusions; diet; microbiota

Additional relevant MeSH terms:

Communicable Diseases; Infections; Hypercholesterolemia; Hyperglycemia; Hyperlipidemias; Inflammation; Overweight; Pathologic Processes; Body Weight; Glucose Metabolism Disorders; Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Disease Attributes