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Completed

NCT Number: NCT04866628

Clinical Trials of Two Helichrysum Infusions in Adults

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.

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Key information

Conditions

Hypertension Body Weight Cardiovascular Diseases Communicable Diseases Disease Attributes Dyslipidemias Glucose Metabolism Disorders Hypercholesterolemia Hyperglycemia Hyperinsulinism Hyperlipidemias Infections Inflammation Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Microbial Colonization Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Helichrysum italicum infusion

Dietary Supplement

Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum italicum infusion.

Helichrysum arenarium

Dietary Supplement

Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum arenarium infusion.

Primary outcomes

  1. 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

  1. Blood pressure

    Time frame: 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)

  2. Inflammation

    Time frame: 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

  3. Anthropometric measurements

    Time frame: 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).

  4. Microbiota

    Time frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout

    The microbiota composition will be determined with gene sequencing

  5. Antioxidative potential

    Time frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout

    Antioxidative potential will be determined with DPPH radical measuremen

  6. Anthropometric measurements

    Time frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout

    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).

  7. Anthropometric measurements Description:

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Registry information

Official study title

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

Acronym: SMILJ

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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