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Completed

NCT Number: NCT04818905

Helichrysum Italicum Infusion Ingestion in Humans

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.

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Key information

Conditions

Energy Expenditure Blood Pressure Substrate Oxidation

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Helichrysum italicum infusion

Dietary Supplement

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 names: Active beverage

Hot water

Other

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 names: Control beverage

Primary outcomes

  1. Change in resting energy expenditure

    Time frame: Change from baseline to 30 minutes and 120 minutes.

    Resting energy expenditure will be determined with indirect calorimetry.

  2. Changes in fat oxidation

    Time frame: Change from baseline to 30 minutes and 120 minutes.

    Substrate oxidation will be determined with indirect calorimetry.

  3. Respiratory quotient

    Time frame: Change from baseline to 30 minutes and 120 minutes.

    Respiratory quotient will be determined with indirect calorimetry.

  4. Blood pressure

    Time frame: Change from baseline to 30 minutes and 120 minutes.

    Systolic and diastolic blood pressures will be determined with blood pressure device (Omron M3)

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Registry information

Official study title

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

Acronym: SMILJ

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2021
Registry last updated
Apr 1, 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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