Helichrysum Italicum Infusion Ingestion in Humans (SMILJ)

March 26, 2021 updated by: Zala Jenko Praznikar, University of Primorska

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Izola, Slovenia, 6310
        • University of Primorska, Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Helichrysum italicum infusion
1 g of milled plant material (Helichrysum italicun) immersed in hot water (200 mL, 100 °C) for 10 minutes.
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 Names:
  • Active beverage
Placebo Comparator: Hot water
The control beverage contained only hot water (200 mL, 100 ˚C).
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.
Other Names:
  • Control beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 30 minutes and 120 minutes.
Changes in fat oxidation
Time Frame: Change from baseline to 30 minutes and 120 minutes.
Substrate oxidation will be determined with indirect calorimetry.
Change from baseline to 30 minutes and 120 minutes.
Respiratory quotient
Time Frame: Change from baseline to 30 minutes and 120 minutes.
Respiratory quotient will be determined with indirect calorimetry.
Change from baseline to 30 minutes and 120 minutes.
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)
Change from baseline to 30 minutes and 120 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Primorska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMILJ_pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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