Helichrysum Italicum Infusion Ingestion in Humans

Not Applicable

Completed

• Conditions: Blood Pressure; Energy Expenditure; Substrate Oxidation

• Registration Number: NCT04818905
• Lead Sponsor: University of Primorska

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-06-15
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-30
• Status Verified: 2021-03
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Primorska, Faculty of Health Sciences; 🇸🇮 Izola, Slovenia