Energy ExpenditureSMILJNCT04818905
Helichrysum Italicum Infusion Ingestion in Humans
A study testing Helichrysum italicum infusion and Hot water in people with Energy Expenditure and Substrate Oxidation, run by University of Primorska at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Energy Expenditure, Substrate Oxidation, Blood Pressure
- What is being tested?
- Helichrysum italicum infusion and Hot water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Jun 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- females, smoking, medications, dietary supplements, metabolic diseases, hypertensive
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska, Faculty of Health Sciences
Izola, 6310
About this study
Official title: 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.
Read the 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.
- Conditions
- Energy Expenditure, Substrate Oxidation, Blood Pressure
- Being tested
- Helichrysum italicum infusion, Hot water
- Keywords
- bioactive compounds, functional beverages, metabolism, helath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helichrysum italicum infusionDietary supplement
Also called Active beverage
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.
Hot waterOther
Also called Control beverage
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.
| Study group | Role | What they receive |
|---|---|---|
| Helichrysum italicum infusion | Experimental | 1 g of milled plant material (Helichrysum italicun) immersed in hot water (200 mL, 100 °C) for 10 minutes. Receives: Dietary Supplement: Helichrysum italicum infusion |
| Hot water | Placebo comparator | The control beverage contained only hot water (200 mL, 100 ˚C). Receives: Other: Hot water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting energy expenditure
Resting energy expenditure will be determined with indirect calorimetry.
Measured: Change from baseline to 30 minutes and 120 minutes.
Changes in fat oxidation
Substrate oxidation will be determined with indirect calorimetry.
Measured: Change from baseline to 30 minutes and 120 minutes.
Respiratory quotient
Respiratory quotient will be determined with indirect calorimetry.
Measured: 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)
Measured: Change from baseline to 30 minutes and 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start15 Jun 2020
- Primary completion1 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Energy ExpenditureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zala Jenko Praznikar, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818905
- Sponsor's protocol ID
- SMILJ_pilot
- Acronym
- SMILJ
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31505825Manach 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.
PubMed 15113710Antunes 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.
PubMed 24239849Soga 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.
PubMed 23924724Kenig 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.
PubMed 34451560
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Helichrysum Italicum Infusion on Resting Energy Expenditure and Fat Oxidation in Humans
- ClinicalTrials.gov ID
- NCT04818905
- Acronym / sponsor ID
- SMILJ / SMILJ_pilot
- Conditions
- Energy Expenditure, Substrate Oxidation, Blood Pressure
- Keywords
- bioactive compounds, functional beverages, metabolism, helath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helichrysum italicum infusion | Experimental | Dietary Supplement: Helichrysum italicum infusion1 g of milled plant material (Helichrysum italicun) immersed in hot water (200 mL, 100 °C) for 10 minutes. |
| Hot water | Placebo comparator | Other: Hot waterThe control beverage contained only hot water (200 mL, 100 ˚C). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- females, smoking, medications, dietary supplements, metabolic diseases, hypertensive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helichrysum italicum infusionAlso: Active beverageActive 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. | Dietary supplement | Helichrysum italicum infusion |
| Hot waterAlso: Control beverageActive 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 | Hot water |
Primary outcome
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.
Changes in fat oxidation
Time frame: Change from baseline to 30 minutes and 120 minutes.
Substrate oxidation will be determined with indirect calorimetry.
Respiratory quotient
Time frame: Change from baseline to 30 minutes and 120 minutes.
Respiratory quotient will be determined with indirect calorimetry.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Background: PubMed 31505825Konstantinidi 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.
- Background: PubMed 15113710Manach 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.
- Background: PubMed 24239849Antunes 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.
- Background: PubMed 23924724Soga 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.
- Derived from this study: PubMed 34451560Kenig 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helichrysum italicum infusion and Hot water in people with Energy Expenditure and Substrate Oxidation, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting energy expenditure (time frame: Change from baseline to 30 minutes and 120 minutes.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04818905, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.