Helichrysum Italicum Infusion Ingestion in Humans

Study Overview
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Brief Summary
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The study evaluates the acute effects of Helichrysum italicum on resting energy expenditure and substrate oxidation in humans. The resting energy expenditure and substrate oxidation will be measured by indirect calorimetry at baseline and after ingestion of either Helichrysum italicum infusion or hot water.

Detailed Description
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Bioactive compounds found in medicinal plants and plant extracts, such as polyphenols, represent the oldest and most widely used form of alternative or complementary treatments for the prevention and management of obesity. Their consumption is currently increasing in the population due to the high cost, potential adverse effects and limited benefits of currently available pharmaceutical drugs. Helichrysum italicum is a mediterranean plant with promising nutraceutical activities. The plant is known as a rich source of biologically active compounds such as polyphenolic antioxidants, which are recognized in the prevention of various non-communicable chronic diseases. However, most of its traditionally claimed uses have not yet been scientifically proven. The proposed study will investigate the acute effect of Helichrysum italicum infusion on resting energy expenditure, substrate oxidation, respiratory quotient and blood pressure in a pilot study of 11 male adults. It will be designed as a crossover study. Half of the participants will consume the Helichrysum italicum infusion and the other half will consume hot water. After seven days of washout period the participants will consume the alternate beverage.

Official Title
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Effects of Helichrysum Italicum Infusion on Resting Energy Expenditure and Fat Oxidation in Humans

Conditions
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Energy Expenditure, Substrate Oxidation, Blood Pressure

Intervention / Treatment
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* Dietary Supplement: Helichrysum italicum infusion
* Other: Hot water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy, weight-stable (±3 kg in the last 3 months), normotensive, non-smokers, no use of dietary supplements or frequent use of medication and no known metabolic disorders. Exclusion Criteria: females, smoking, medications, dietary supplements, metabolic diseases, hypertensive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helichrysum italicum infusion<br>1 g of milled plant material (Helichrysum italicun) immersed in hot water (200 mL, 100 °C) for 10 minutes. | Dietary Supplement: Helichrysum italicum infusion<br>* Active beverage or control beverage consumption after overnight fasting and calorimetry measurement on a single subject. After seven days washout period follows the consumption of the alternate beverage and measurements.<br>* Other names: Active beverage;|
| Placebo Comparator: Hot water<br>The control beverage contained only hot water (200 mL, 100 ˚C). | Other: Hot water<br>* Active beverage or control beverage consumption after overnight fasting and calorimetry measurement on a single subject. After seven days washout period follows the consumption of the alternate beverage and measurements.<br>* Other names: Control beverage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in resting energy expenditure | Resting energy expenditure will be determined with indirect calorimetry. | Change from baseline to 30 minutes and 120 minutes. | 
| Changes in fat oxidation | Substrate oxidation will be determined with indirect calorimetry. | Change from baseline to 30 minutes and 120 minutes. | 
| Respiratory quotient | Respiratory quotient will be determined with indirect calorimetry. | Change from baseline to 30 minutes and 120 minutes. | 
| Blood pressure | Systolic and diastolic blood pressures will be determined with blood pressure device (Omron M3) | Change from baseline to 30 minutes and 120 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioactive compounds, functional beverages, metabolism, helath