Clinical trial NCT04866628: Clinical Trials of Two Helichrysum Infusions in Adults
Official title: Comparison of Helichrysum Italicum Infusion and Helichrysum Arenarium Infusion Effects on the Components of Metabolic Syndrome in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Hyperlipidemias
Inflammation
Hyperglycemia
Hypercholesterolemia
Microbial Colonization
Overweight and Obesity
Keywords: metabolic syndrome
herbal infusions
diet
microbiota
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Lipid profile
timeFrame: changes from baseline to four weeks of daily consumption and after two weeks of washout
Secondary outcomes:
measure: Blood pressure
timeFrame: changes from baseline to four weeks of daily consumption and after two weeks of washout
measure: Inflammation
timeFrame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
measure: Anthropometric measurements
timeFrame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
measure: Microbiota
timeFrame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
measure: Antioxidative potential
timeFrame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
measure: Anthropometric measurements
timeFrame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
measure: Anthropometric measurements Description:
timeFrame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.