Comparison of Helichrysum Italicum Infusion and Helichrysum Arenarium Infusion Effects on the Components of Metabolic Syndrome in Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Primorska
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Lipid profile
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Helichrysum italicum
1 g of milled plant material (Helichrysum italicum) immersed in hot water (200 mL, 100 °C) for 10minutes
Intervention: Helichrysum italicum infusion (Dietary Supplement)
Helichrysum arenarium
1 g of milled plant material (Helichrysum arenarium) immersed in hot water (200 mL, 100 °C) for 10minutes
Intervention: Helichrysum arenarium (Dietary Supplement)
Outcomes
Primary Outcomes
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 Outcomes
- Anthropometric measurements Description:(Chages from baseline to four weeks of daily consumption and after two weeks of washout)
- Anthropometric measurements(Chages from baseline to four weeks of daily consumption and after two weeks of washout)
- Blood pressure(changes from baseline to four weeks of daily consumption and after two weeks of washout)
- Inflammation(Chages from baseline to four weeks of daily consumption and after two weeks of washout)
- Microbiota(Chages from baseline to four weeks of daily consumption and after two weeks of washout)
- Antioxidative potential(Chages from baseline to four weeks of daily consumption and after two weeks of washout)
Investigators
Zala Jenko Praznikar
Associate professor
University of Primorska