Clinical trial NCT04818905: Helichrysum Italicum Infusion Ingestion in Humans
Official title: Effects of Helichrysum Italicum Infusion on Resting Energy Expenditure and Fat Oxidation in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Expenditure
Substrate Oxidation
Blood Pressure
Keywords: bioactive compounds
functional beverages
metabolism
helath
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in resting energy expenditure
timeFrame: Change from baseline to 30 minutes and 120 minutes.
measure: Changes in fat oxidation
timeFrame: Change from baseline to 30 minutes and 120 minutes.
measure: Respiratory quotient
timeFrame: Change from baseline to 30 minutes and 120 minutes.
measure: Blood pressure
timeFrame: Change from baseline to 30 minutes and 120 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
Study officials:
References:
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):94. doi: 10.3390/medicines6030094.
citation: Manach C, Scalbert A, Morand C, Remesy C, Jimenez L. Polyphenols: food sources and bioavailability. Am J Clin Nutr. 2004 May;79(5):727-47. doi: 10.1093/ajcn/79.5.727.
citation: 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.
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. doi: 10.1271/bbb.130147. Epub 2013 Aug 7.
citation: Kenig S, Kramberger K, Petelin A, Bandelj D, Baruca Arbeiter A, Miklavcic Visnjevec A, Peeters K, Mohorko N, Sik Novak K, Jenko Praznikar Z. Helichrysum italicum ssp. italicum Infusion Promotes Fat Oxidation in Hepatocytes and Stimulates Energy Expenditure and Fat Oxidation after Acute Ingestion in Humans: A Pilot Study. Plants (Basel). 2021 Jul 23;10(8):1516. doi: 10.3390/plants10081516.