Trials / Completed
CompletedNCT04866628
Clinical Trials of Two Helichrysum Infusions in Adults
Comparison of Helichrysum Italicum Infusion and Helichrysum Arenarium Infusion Effects on the Components of Metabolic Syndrome in Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Primorska · Academic / Other
- Sex
- All
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Helichrysum italicum infusion | Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum italicum infusion. |
| DIETARY_SUPPLEMENT | Helichrysum arenarium | Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum arenarium infusion. |
Timeline
- Start date
- 2021-05-06
- Primary completion
- 2021-06-03
- Completion
- 2021-06-19
- First posted
- 2021-04-30
- Last updated
- 2021-09-29
Locations
1 site across 1 country: Slovenia
Source: ClinicalTrials.gov record NCT04866628. Inclusion in this directory is not an endorsement.