Hypercholesterolemia, Hyperglycemia, Hyperlipidemias, Hypertension, Inflammation, Microbial Colonization, Overweight and Obesity
Conditions
Keywords
metabolic syndrome, herbal infusions, diet, microbiota
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.
Interventions
DIETARY_SUPPLEMENTHelichrysum italicum infusion
Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum italicum infusion.
DIETARY_SUPPLEMENTHelichrysum arenarium
Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum arenarium infusion.
Sponsors
University of Primorska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile | 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
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | Chages from baseline to four weeks of daily consumption and after two weeks of washout | Changes in C-reactive protein levels will be examined with biochemical analyzer Cobass |
| Anthropometric measurements | Chages from baseline to four weeks of daily consumption and after two weeks of washout | 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). |
| Blood pressure | changes from baseline to four weeks of daily consumption and after two weeks of washout | Systolic and diastolic blood pressure will be determined with blood pressure device (Omron M3) |
| Antioxidative potential | Chages from baseline to four weeks of daily consumption and after two weeks of washout | Antioxidative potential will be determined with DPPH radical measuremen |
| Anthropometric measurements Description: | Chages from baseline to four weeks of daily consumption and after two weeks of washout | 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). |
| Microbiota | Chages from baseline to four weeks of daily consumption and after two weeks of washout | The microbiota composition will be determined with gene sequencing |
Countries
Slovenia
Outcome results
None listed