Clinical Trials of Two Helichrysum Infusions in Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Helichrysum Italicum Infusion and Helichrysum Arenarium Infusion Effects on the Components of Metabolic Syndrome in Adults

Conditions
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Hyperglycemia, Hypercholesterolemia, Microbial Colonization, Overweight and Obesity, Hypertension, Hyperlipidemias, Inflammation

Intervention / Treatment
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* Dietary Supplement: Helichrysum italicum infusion
* Dietary Supplement: Helichrysum arenarium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helichrysum italicum<br>1 g of milled plant material (Helichrysum italicum) immersed in hot water (200 mL, 100 °C) for 10minutes | Dietary Supplement: Helichrysum italicum infusion<br>* Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum italicum infusion.<br>|
| Active Comparator: Helichrysum arenarium<br>1 g of milled plant material (Helichrysum arenarium) immersed in hot water (200 mL, 100 °C) for 10minutes | Dietary Supplement: Helichrysum arenarium<br>* Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum arenarium infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides will be examined with biochemical analyzer Cobass | changes from baseline to four weeks of daily consumption and after two weeks of washout | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressure will be determined with blood pressure device (Omron M3) | changes from baseline to four weeks of daily consumption and after two weeks of washout | 
| Inflammation | Changes in C-reactive protein levels will be examined with biochemical analyzer Cobass | Chages from baseline to four weeks of daily consumption and after two weeks of washout | 
| Anthropometric measurements | 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). | Chages from baseline to four weeks of daily consumption and after two weeks of washout | 
| Microbiota | The microbiota composition will be determined with gene sequencing | Chages from baseline to four weeks of daily consumption and after two weeks of washout | 
| Antioxidative potential | Antioxidative potential will be determined with DPPH radical measuremen | Chages from baseline to four weeks of daily consumption and after two weeks of washout | 
| Anthropometric measurements | Changes in visceral fat rating will be examined with bioelectrical impedance analysis (BIA) Tanita MC-980MA (Maeno-cho, Japan) and dedicated software (GMON Pro-Tanita). | Chages from baseline to four weeks of daily consumption and after two weeks of washout | 
| Anthropometric measurements Description: | 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). | Chages from baseline to four weeks of daily consumption and after two weeks of washout | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, herbal infusions, diet, microbiota