Helichrysum Italicum Infusion Ingestion in Humans (SMILJ)

University of Primorska

Status: Completed

Conditions: Substrate Oxidation; Energy Expenditure; Blood Pressure

Treatments: Dietary Supplement: Helichrysum italicum infusion; Other: Hot water

Study type: Interventional

Funder types: Other

Identifiers

NCT04818905

SMILJ_pilot

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 2 patient groups, including a placebo group

Helichrysum italicum infusion

Experimental group

Description:

1 g of milled plant material (Helichrysum italicun) immersed in hot water (200 mL, 100 °C) for 10 minutes.

Treatment:

Dietary Supplement: Helichrysum italicum infusion

Hot water

Placebo Comparator group

Description:

The control beverage contained only hot water (200 mL, 100 ˚C).

Treatment:

Other: Hot water