NCT04818905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 25, 2021

Last Update Submit

March 26, 2021

Conditions

Energy ExpenditureSubstrate OxidationBlood Pressure

Keywords

bioactive compoundsfunctional beveragesmetabolismhelath

Outcome Measures

Primary Outcomes (4)

  • Change in resting energy expenditure

    Resting energy expenditure will be determined with indirect calorimetry.

    Change from baseline to 30 minutes and 120 minutes.

  • Changes in fat oxidation

    Substrate oxidation will be determined with indirect calorimetry.

    Change from baseline to 30 minutes and 120 minutes.

  • Respiratory quotient

    Respiratory quotient will be determined with indirect calorimetry.

    Change from baseline to 30 minutes and 120 minutes.

  • 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.

Study Arms (2)

Helichrysum italicum infusion

EXPERIMENTAL

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

Dietary Supplement: Helichrysum italicum infusion

Hot water

PLACEBO COMPARATOR

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

Other: Hot water

Interventions

Helichrysum italicum infusionDIETARY_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.

Also known as: Active beverage
Helichrysum italicum infusion
Hot waterOTHER

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.

Also known as: Control beverage
Hot water

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • females, smoking, medications, dietary supplements, metabolic diseases, hypertensive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

Location

Related Publications (5)

  • 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.

    PMID: 31505825BACKGROUND

  • 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.

    PMID: 15113710BACKGROUND

  • 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.

    PMID: 24239849BACKGROUND

  • 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.

    PMID: 23924724BACKGROUND

  • 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.

    PMID: 34451560DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 26, 2021

Study Start

June 15, 2020

Primary Completion

August 1, 2020

Study Completion

September 30, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

SL(1)