Helichrysum Italicum Infusion Ingestion in Humans

Blood Pressure Clinical Trial

— SMILJ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818905
• Other study ID #: SMILJ_pilot
• Status: Completed
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: March 2021
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 30, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Energy Expenditure
• Substrate Oxidation

Intervention

Dietary Supplement:
• Helichrysum italicum infusion
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.

Other:
• Hot water
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.

Locations

Country	Name	City	State
Slovenia	University of Primorska, Faculty of Health Sciences	Izola

Sponsors (1)

Lead Sponsor	Collaborator
University of Primorska

Country where clinical trial is conducted

Slovenia, 

References & Publications (4)

Antunes Viegas D, Palmeira-de-Oliveira A, Salgueiro L, Martinez-de-Oliveira J, Palmeira-de-Oliveira R. Helichrysum italicum: from traditional use to scientific data. J Ethnopharmacol. 2014;151(1):54-65. doi: 10.1016/j.jep.2013.11.005. Epub 2013 Nov 14. Review. — View Citation

Konstantinidi M, Koutelidakis AE. Functional Foods and Bioactive Compounds: A Review of Its Possible Role on Weight Management and Obesity's Metabolic Consequences. Medicines (Basel). 2019 Sep 9;6(3). pii: E94. doi: 10.3390/medicines6030094. Review. — View Citation

Manach C, Scalbert A, Morand C, Rémésy C, Jiménez L. Polyphenols: food sources and bioavailability. Am J Clin Nutr. 2004 May;79(5):727-47. Review. — View Citation

Soga S, Ota N, Shimotoyodome A. Stimulation of postprandial fat utilization in healthy humans by daily consumption of chlorogenic acids. Biosci Biotechnol Biochem. 2013;77(8):1633-6. Epub 2013 Aug 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in resting energy expenditure	Resting energy expenditure will be determined with indirect calorimetry.	Change from baseline to 30 minutes and 120 minutes.
Primary	Changes in fat oxidation	Substrate oxidation will be determined with indirect calorimetry.	Change from baseline to 30 minutes and 120 minutes.
Primary	Respiratory quotient	Respiratory quotient will be determined with indirect calorimetry.	Change from baseline to 30 minutes and 120 minutes.
Primary	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.