Clinical Trials of Two Helichrysum Infusions in Adults

NCT ID: NCT04866628

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2021-06-19

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.

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.

Conditions

Hypertension; Hyperlipidemias; Inflammation; Hyperglycemia; Hypercholesterolemia; Microbial Colonization; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Helichrysum italicum

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

Group Type: EXPERIMENTAL

Helichrysum italicum infusion

Intervention Type: DIETARY_SUPPLEMENT

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

Helichrysum arenarium

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

Group Type: ACTIVE_COMPARATOR

Helichrysum arenarium

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Helichrysum italicum infusion

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

Intervention Type: DIETARY_SUPPLEMENT

Helichrysum arenarium

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Primorska

OTHER

Sponsor Role: lead

Responsible Party

Zala Jenko Praznikar

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Primorska, Faculty of Health Sciences

Izola, , Slovenia

Countries

Slovenia

References

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.

Reference Type: BACKGROUND

PMID: 30131818 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11902802 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33802628 (View on PubMed)

Other Identifiers

SMILJ_Clinical

Identifier Type: -

Identifier Source: org_study_id