HypertensionSMILJNCT04866628
Clinical Trials of Two Helichrysum Infusions in Adults
A study testing Helichrysum italicum infusion and Helichrysum arenarium in people with Hypertension and Hyperlipidemias, run by University of Primorska at 1 site in Slovenia.
Trial summary
The study evaluates the effects of Helichrysum italicum and Helichrysum Arenarium on different components of the metabolic syndrome. The components of metabolic syndrome will be measured at baseline and four weeks after daily consumptions of either Helichrysum italicum or either Helichrysum Arenarium, and after two… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hyperlipidemias, Inflammation
- What is being tested?
- Helichrysum italicum infusion and Helichrysum arenarium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 6 May 2021to 19 Jun 2021
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stable weight in the last 3 months
- BMI more than 25
- clinical diagnosis of at least two components of metabolic syndrome,
Who cannot join
- consumption of dietary supplements
- medications for any component of metabolic syndrome
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: Comparison of Helichrysum Italicum Infusion and Helichrysum Arenarium Infusion Effects on the Components of Metabolic Syndrome in Adults
The study evaluates the effects of Helichrysum italicum and Helichrysum Arenarium on different components of the metabolic syndrome. The components of metabolic syndrome will be measured at baseline and four weeks after daily consumptions of either Helichrysum italicum or either Helichrysum Arenarium, and after two weeks of washout. In addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either Helichrysum italicum or either Helichrysum Arenarium.
Read the detailed description
Helichrysum arenarium (HA) has a long tradition in European ethno-medicine as a medicinal plant with many known activities; EU monograph supports its use for the digestive disorders, feeling of fullness and bloating, and, importantly, it re-ports no side effects. Assessment report of the European Medicines Agency Committee on Herbal Medicinal Products supports its stimulatory role in the bile flow and in the release of cholesterol to the bile. HA has also been used in chronic liver inflammatory disease and as a scavenger of free radicals. Similar to HA Helichrysum italicum (HI) is widely used in traditional medicine. Lately, much attention has been given to natural antioxidants and their ability to delay the progression of chronic diseases related to the formation and the activity of reactive oxygen species and other free radicals. Herbs are very often used to prepare recreational tea and are thereby important sources of antioxidants in different cultures. In traditional medicine, HI is also used in diet, mainly for the preparation of infusions in treating respiratory and digestive conditions.
Therefore,the ail of our study is to evaluate the effects of Helichrysum italicum and Helichrysum Arenarium on different components of the metabolic syndrome in adults presenting at least two components of metabolic syndrome and yet not receiving any medication. The components of metabolic syndrome (lipid profile, blood pressure, antrophometry, inflammation status, glucose levels) will be measured at baseline and four weeks after daily consumptions of either Helichrysum italicum or either Helichrysum Arenarium, and after two weeks of washout. In addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either Helichrysum italicum or either Helichrysum Arenarium.
- Conditions
- Hypertension, Hyperlipidemias, Inflammation, Hyperglycemia, Hypercholesterolemia, Microbial Colonization
- Being tested
- Helichrysum italicum infusion, Helichrysum arenarium
- Keywords
- metabolic syndrome, herbal infusions, diet, microbiota
- Medical subject headings
- Hypertension, Hyperlipidemias, Inflammation, Hyperglycemia, Hypercholesterolemia, Communicable Diseases, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helichrysum italicum infusionDietary supplement
Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum italicum infusion.
Helichrysum arenariumDietary supplement
Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum arenarium infusion.
| Study group | Role | What they receive |
|---|---|---|
| Helichrysum italicum | Experimental | 1 g of milled plant material (Helichrysum italicum) immersed in hot water (200 mL, 100 °C) for 10minutes Receives: Dietary Supplement: Helichrysum italicum infusion |
| Helichrysum arenarium | Active comparator | 1 g of milled plant material (Helichrysum arenarium) immersed in hot water (200 mL, 100 °C) for 10minutes Receives: Dietary Supplement: Helichrysum arenarium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides will be examined with biochemical analyzer Cobass
Measured: changes from baseline to four weeks of daily consumption and after two weeks of washout
Secondary outcomes (7)
Blood pressure
Systolic and diastolic blood pressure will be determined with blood pressure device (Omron M3)
Measured: changes from baseline to four weeks of daily consumption and after two weeks of washout
Inflammation
Changes in C-reactive protein levels will be examined with biochemical analyzer Cobass
Measured: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Anthropometric measurements
Changes in body weight (in kilograms) will be examined with bioelectrical impedance analysis (BIA) Tanita MC-980MA (Maeno-cho, Japan) and dedicated software (GMON Pro-Tanita).
Measured: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Microbiota
The microbiota composition will be determined with gene sequencing
Measured: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Antioxidative potential
Antioxidative potential will be determined with DPPH radical measuremen
Measured: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Anthropometric measurements
Changes in visceral fat rating will be examined with bioelectrical impedance analysis (BIA) Tanita MC-980MA (Maeno-cho, Japan) and dedicated software (GMON Pro-Tanita).
Measured: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Anthropometric measurements Description:
Changes in fat (percentage of body fat) will be examined with bioelectrical impedance analysis (BIA) Tanita MC-980MA (Maeno-cho, Japan) and dedicated software (GMON Pro-Tanita).
Measured: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start6 May 2021
- Primary completion3 Jun 2021
- Study completion19 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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
- NCT04866628
- Sponsor's protocol ID
- SMILJ_Clinical
- Acronym
- SMILJ
- Status last verified
- Sep 2021
- First submitted
- 23 Apr 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pljevljakusic D, Bigovic D, Jankovic T, Jelacic S, Savikin K. Sandy Everlasting (Helichrysum arenarium (L.) Moench): Botanical, Chemical and Biological Properties. Front Plant Sci. 2018 Aug 7;9:1123. doi: 10.3389/fpls.2018.01123. eCollection 2018.
PubMed 30131818Sala A, Recio M, Giner RM, Manez S, Tournier H, Schinella G, Rios JL. Anti-inflammatory and antioxidant properties of Helichrysum italicum. J Pharm Pharmacol. 2002 Mar;54(3):365-71. doi: 10.1211/0022357021778600.
PubMed 11902802Kramberger K, Jenko Praznikar Z, Baruca Arbeiter A, Petelin A, Bandelj D, Kenig S. A Comparative Study of the Antioxidative Effects of Helichrysum italicum and Helichrysum arenarium Infusions. Antioxidants (Basel). 2021 Mar 3;10(3):380. doi: 10.3390/antiox10030380.
PubMed 33802628
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Helichrysum Italicum Infusion and Helichrysum Arenarium Infusion Effects on the Components of Metabolic Syndrome in Adults
- ClinicalTrials.gov ID
- NCT04866628
- Acronym / sponsor ID
- SMILJ / SMILJ_Clinical
- Conditions
- Hypertension, Hyperlipidemias, Inflammation, Hyperglycemia, Hypercholesterolemia, Microbial Colonization
- Keywords
- metabolic syndrome, herbal infusions, diet, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 19 Jun 2021 (actual)
- First posted
- 30 Apr 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 effects of Helichrysum italicum and Helichrysum Arenarium on different components of the metabolic syndrome. The components of metabolic syndrome will be measured at baseline and four weeks after daily consumptions of either Helichrysum italicum or either Helichrysum Arenarium, and after two weeks of washout. In addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either Helichrysum italicum or either Helichrysum Arenarium.
Detailed description
Helichrysum arenarium (HA) has a long tradition in European ethno-medicine as a medicinal plant with many known activities; EU monograph supports its use for the digestive disorders, feeling of fullness and bloating, and, importantly, it re-ports no side effects. Assessment report of the European Medicines Agency Committee on Herbal Medicinal Products supports its stimulatory role in the bile flow and in the release of cholesterol to the bile. HA has also been used in chronic liver inflammatory disease and as a scavenger of free radicals. Similar to HA Helichrysum italicum (HI) is widely used in traditional medicine. Lately, much attention has been given to natural antioxidants and their ability to delay the progression of chronic diseases related to the formation and the activity of reactive oxygen species and other free radicals. Herbs are very often used to prepare recreational tea and are thereby important sources of antioxidants in different cultures. In traditional medicine, HI is also used in diet, mainly for the preparation of infusions in treating respiratory and digestive conditions.
Therefore,the ail of our study is to evaluate the effects of Helichrysum italicum and Helichrysum Arenarium on different components of the metabolic syndrome in adults presenting at least two components of metabolic syndrome and yet not receiving any medication. The components of metabolic syndrome (lipid profile, blood pressure, antrophometry, inflammation status, glucose levels) will be measured at baseline and four weeks after daily consumptions of either Helichrysum italicum or either Helichrysum Arenarium, and after two weeks of washout. In addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either Helichrysum italicum or either Helichrysum Arenarium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helichrysum italicum | Experimental | Dietary Supplement: Helichrysum italicum infusion1 g of milled plant material (Helichrysum italicum) immersed in hot water (200 mL, 100 °C) for 10minutes |
| Helichrysum arenarium | Active comparator | Dietary Supplement: Helichrysum arenarium1 g of milled plant material (Helichrysum arenarium) immersed in hot water (200 mL, 100 °C) for 10minutes |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stable weight in the last 3 months
- BMI more than 25
- clinical diagnosis of at least two components of metabolic syndrome,
Key exclusion criteria (2 listed)
- consumption of dietary supplements
- medications for any component of metabolic syndrome
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 infusionComparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum italicum infusion. | Dietary supplement | Helichrysum italicum |
| Helichrysum arenariumComparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum arenarium infusion. | Dietary supplement | Helichrysum arenarium |
Primary outcome
Lipid profile
Time frame: changes from baseline to four weeks of daily consumption and after two weeks of washout
Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides will be examined with biochemical analyzer Cobass
7 secondary outcomes
Blood pressure
Time frame: changes from baseline to four weeks of daily consumption and after two weeks of washout
Inflammation
Time frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Anthropometric measurements
Time frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Microbiota
Time frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Antioxidative potential
Time frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Anthropometric measurements
Time frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
Anthropometric measurements Description:
Time frame: Chages from baseline to four weeks of daily consumption and after two weeks of washout
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 29 Sep 2021.
- Background: PubMed 30131818Pljevljakusic D, Bigovic D, Jankovic T, Jelacic S, Savikin K. Sandy Everlasting (Helichrysum arenarium (L.) Moench): Botanical, Chemical and Biological Properties. Front Plant Sci. 2018 Aug 7;9:1123. doi: 10.3389/fpls.2018.01123. eCollection 2018.
- Background: PubMed 11902802Sala A, Recio M, Giner RM, Manez S, Tournier H, Schinella G, Rios JL. Anti-inflammatory and antioxidant properties of Helichrysum italicum. J Pharm Pharmacol. 2002 Mar;54(3):365-71. doi: 10.1211/0022357021778600.
- Background: PubMed 33802628Kramberger K, Jenko Praznikar Z, Baruca Arbeiter A, Petelin A, Bandelj D, Kenig S. A Comparative Study of the Antioxidative Effects of Helichrysum italicum and Helichrysum arenarium Infusions. Antioxidants (Basel). 2021 Mar 3;10(3):380. doi: 10.3390/antiox10030380.
- 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 Helichrysum arenarium in people with Hypertension and Hyperlipidemias, 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 3 inclusion and 2 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 29 Sep 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. 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?
Lipid profile (time frame: changes from baseline to four weeks of daily consumption and after two weeks of washout). 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 NCT04866628, which also lists 3 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 29 Sep 2021.