Safety / ToxicologyNCT07189143
Silver Fir Safety in Healthy Volunteers
A study testing Belinal® (Abies alba branch extract) in people with Safety / Toxicology and Liver Function, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
This study evaluated the safety of Belinal®, a dietary supplement made from silver fir (Abies alba) branch extract, in healthy volunteers. Fifteen adults took 900 mg of Belinal® daily for 14 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety / Toxicology, Liver Function, Kidney Function
- What is being tested?
- Belinal® (Abies alba branch extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Aug 2018to 29 Oct 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers
- Age 37-55 years
- Both sexes (male and female)
- Willingness to comply with study protocol and attend all study visits
- Signed informed consent
Who cannot join
- Known acute or chronic illness
- Use of any medications other than occasional analgesics (none were used by participants)
- Use of dietary supplements prior to or during the study
- Known mental illness (e.g., depression, psychosis, severe alcoholism, drug abuse)
- Consumption of more than 2 alcohol units per day (20 g ethanol, equivalent to ~2 dl wine, 5 dl beer, or 0.3 dl brandy)
- Participation in other research studies concurrently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Silver Fir Branch Extract on Liver and Kidney Function
This study evaluated the safety of Belinal®, a dietary supplement made from silver fir (Abies alba) branch extract, in healthy volunteers. Fifteen adults took 900 mg of Belinal® daily for 14 days. Blood tests were performed at several time points to measure liver and kidney function (enzymes and other biochemical markers).
Read the detailed description
This was a prospective, open-label, single-arm interventional study conducted to assess the toxicological safety of Belinal®, a standardized water extract from silver fir (Abies alba) branches. Belinal® contains polyphenols, including lignans, flavonoids, and phenolic acids, which have demonstrated various pharmacological activities in previous studies.
The study enrolled 15 healthy volunteers (8 men, 7 women; age range 37-55 years). Participants received Belinal® capsules at a total daily dose of 900 mg (4 × 225 mg) for 14 consecutive days.
The study design included three consecutive two-week periods:
Wash-out period: to eliminate potential effects of prior supplement use. Comparative period: to assess natural variability in laboratory parameters without supplementation.
Test period: during which participants consumed Belinal® daily. Safety was evaluated by measuring liver and kidney biochemical parameters (AST, ALT, ALP, GGT, bilirubin, urea, creatinine, uric acid) at baseline, day 14, day 28, and day 42. Adverse events were monitored throughout the study.
- Conditions
- Safety / Toxicology, Liver Function, Kidney Function, Dietary Supplement, Healthy Volunteers
- Being tested
- Belinal® (Abies alba branch extract)
- Keywords
- Abies alba, Silver fir extract, Dietary supplement, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belinal® (Abies alba branch extract)Dietary supplement
Belinal® capsules, 900 mg/day (4 × 225 mg), orally for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Belinal® Group | Experimental | Participants received Belinal® (Abies alba branch extract) capsules at a total daily dose of 900 mg (4 × 225 mg) for 14 consecutive days. The supplement was taken orally in divided doses throughout the day. Receives: Dietary Supplement: Belinal® (Abies alba branch extract) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum AST
Change in aspartate aminotransferase (AST) to evaluate potential hepatotoxic effects. Unit of Measure: U/L
Measured: Baseline, Day 14, Day 28, and Day 42.
Change in serum ALT
Change in alanine aminotransferase (ALT) to evaluate potential hepatotoxic effects. Unit of Measure: U/L
Measured: Baseline, Day 14, Day 28, Day 42.
Change in serum ALP
Change in alkaline phosphatase (ALP) levels to evaluate potential hepatobiliary effects. Unit of Measure: U/L
Measured: Baseline, Day 14, Day 28, Day 42.
Change in serum GGT
Change in gamma-glutamyl transferase (GGT) levels to evaluate potential hepatobiliary effects. Unit of Measure: U/L
Measured: Baseline, Day 14, Day 28, Day 42.
Change in serum bilirubin
Change in total bilirubin as a marker of liver function. Unit of Measure: µmol/L
Measured: Baseline, Day 14, Day 28, Day 42.
Change in serum urea
Change in blood urea levels as a marker of kidney function. Unit of Measure: mmol/L
Measured: Baseline, Day 14, Day 28, Day 42.
Change in serum creatinine
Change in serum creatinine levels as a marker of kidney function. Unit of Measure: µmol/L
Measured: Baseline, Day 14, Day 28, Day 42.
Change in serum uric acid
Change in uric acid levels as a marker of kidney function. Unit of Measure: µmol/L
Measured: Baseline, Day 14, Day 28, Day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start20 Aug 2018
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety / ToxicologyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189143
- Sponsor's protocol ID
- 0120-642/2017/5
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schoss K, Kreft S. Assessment of Liver and Kidney Safety of Silver Fir (Abies alba) Branch Extract: An Open-Label Human Study of a Dietary Supplement. Food Sci Nutr. 2026 Jul 14;14(7):e71991. doi: 10.1002/fsn3.71991. eCollection 2026 Jul.
PubMed 42454226
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Silver Fir Branch Extract on Liver and Kidney Function
- ClinicalTrials.gov ID
- NCT07189143
- Acronym / sponsor ID
- 0120-642/2017/5
- Conditions
- Safety / Toxicology, Liver Function, Kidney Function, Dietary Supplement, Healthy Volunteers
- Keywords
- Abies alba, Silver fir extract, Dietary supplement, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 23 Sep 2025 (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.
This study evaluated the safety of Belinal®, a dietary supplement made from silver fir (Abies alba) branch extract, in healthy volunteers. Fifteen adults took 900 mg of Belinal® daily for 14 days. Blood tests were performed at several time points to measure liver and kidney function (enzymes and other biochemical markers).
Detailed description
This was a prospective, open-label, single-arm interventional study conducted to assess the toxicological safety of Belinal®, a standardized water extract from silver fir (Abies alba) branches. Belinal® contains polyphenols, including lignans, flavonoids, and phenolic acids, which have demonstrated various pharmacological activities in previous studies.
The study enrolled 15 healthy volunteers (8 men, 7 women; age range 37-55 years). Participants received Belinal® capsules at a total daily dose of 900 mg (4 × 225 mg) for 14 consecutive days.
The study design included three consecutive two-week periods:
Wash-out period: to eliminate potential effects of prior supplement use. Comparative period: to assess natural variability in laboratory parameters without supplementation.
Test period: during which participants consumed Belinal® daily. Safety was evaluated by measuring liver and kidney biochemical parameters (AST, ALT, ALP, GGT, bilirubin, urea, creatinine, uric acid) at baseline, day 14, day 28, and day 42. Adverse events were monitored throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belinal® Group | Experimental | Dietary Supplement: Belinal® (Abies alba branch extract)Participants received Belinal® (Abies alba branch extract) capsules at a total daily dose of 900 mg (4 × 225 mg) for 14 consecutive days. The supplement was taken orally in divided doses throughout the day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adult volunteers
- Age 37-55 years
- Both sexes (male and female)
- Willingness to comply with study protocol and attend all study visits
- Signed informed consent
Key exclusion criteria (6 listed)
- Known acute or chronic illness
- Use of any medications other than occasional analgesics (none were used by participants)
- Use of dietary supplements prior to or during the study
- Known mental illness (e.g., depression, psychosis, severe alcoholism, drug abuse)
- Consumption of more than 2 alcohol units per day (20 g ethanol, equivalent to ~2 dl wine, 5 dl beer, or 0.3 dl brandy)
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 |
|---|---|---|
| Belinal® (Abies alba branch extract)Belinal® capsules, 900 mg/day (4 × 225 mg), orally for 14 consecutive days. | Dietary supplement | Belinal® Group |
Primary outcome
Change in serum AST
Time frame: Baseline, Day 14, Day 28, and Day 42.
Change in aspartate aminotransferase (AST) to evaluate potential hepatotoxic effects. Unit of Measure: U/L
Change in serum ALT
Time frame: Baseline, Day 14, Day 28, Day 42.
Change in alanine aminotransferase (ALT) to evaluate potential hepatotoxic effects. Unit of Measure: U/L
Change in serum ALP
Time frame: Baseline, Day 14, Day 28, Day 42.
Change in alkaline phosphatase (ALP) levels to evaluate potential hepatobiliary effects. Unit of Measure: U/L
Change in serum GGT
Time frame: Baseline, Day 14, Day 28, Day 42.
Change in gamma-glutamyl transferase (GGT) levels to evaluate potential hepatobiliary effects. Unit of Measure: U/L
Change in serum bilirubin
Time frame: Baseline, Day 14, Day 28, Day 42.
Change in total bilirubin as a marker of liver function. Unit of Measure: µmol/L
Change in serum urea
Time frame: Baseline, Day 14, Day 28, Day 42.
Change in blood urea levels as a marker of kidney function. Unit of Measure: mmol/L
Change in serum creatinine
Time frame: Baseline, Day 14, Day 28, Day 42.
Change in serum creatinine levels as a marker of kidney function. Unit of Measure: µmol/L
Change in serum uric acid
Time frame: Baseline, Day 14, Day 28, Day 42.
Change in uric acid levels as a marker of kidney function. Unit of Measure: µmol/L
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 23 Sep 2025.
- Derived from this study: PubMed 42454226Schoss K, Kreft S. Assessment of Liver and Kidney Safety of Silver Fir (Abies alba) Branch Extract: An Open-Label Human Study of a Dietary Supplement. Food Sci Nutr. 2026 Jul 14;14(7):e71991. doi: 10.1002/fsn3.71991. eCollection 2026 Jul.
- Belinal® informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Belinal® (Abies alba branch extract) in people with Safety / Toxicology and Liver Function, run by University of Ljubljana 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 5 inclusion and 6 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 23 Sep 2025. 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?
Change in serum AST (time frame: Baseline, Day 14, Day 28, and Day 42.). The study lists 8 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 NCT07189143, which also lists 1 linked publication.
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 23 Sep 2025.