Clinical Trials of Two Helichrysum Infusions in Adults

Hypertension Clinical Trial

— SMILJ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866628
• Other study ID #: SMILJ_Clinical
• Status: Completed
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: June 19, 2021

Study information

• Verified date: September 2021
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 19, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hypercholesterolemia
• Hyperglycemia
• Hyperlipidemias
• Hypertension
• Infections
• Inflammation
• Microbial Colonization
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Helichrysum italicum infusion
Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum italicum infusion.
• Helichrysum arenarium
Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum arenarium infusion.

Locations

Country	Name	City	State
Slovenia	University of Primorska, Faculty of Health Sciences	Izola

Sponsors (1)

Lead Sponsor	Collaborator
University of Primorska

Country where clinical trial is conducted

Slovenia, 

References & Publications (3)

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. — View Citation

Pljevljakušic D, Bigovic D, Jankovic T, Jelacic 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood pressure	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
Secondary	Inflammation	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
Secondary	Anthropometric measurements	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
Secondary	Microbiota	The microbiota composition will be determined with gene sequencing	Chages from baseline to four weeks of daily consumption and after two weeks of washout
Secondary	Antioxidative potential	Antioxidative potential will be determined with DPPH radical measuremen	Chages from baseline to four weeks of daily consumption and after two weeks of washout
Secondary	Anthropometric measurements	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
Secondary	Anthropometric measurements Description:	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