Silver Fir Safety in Healthy Volunteers

NCT07189143 | Completed

• 1 other identifier: 0120-642/2017/5
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. Blood tests were performed at several time points to measure liver and kidney function (enzymes and other biochemical markers).

Conditions

Safety / Toxicology; Liver Function; Kidney Function; Dietary Supplement; Healthy Volunteers

Keywords

Abies alba; Silver fir extract; Dietary supplement; Safety

Outcome Measures

Primary Outcomes (8)

• Change in serum AST

  Change in aspartate aminotransferase (AST) to evaluate potential hepatotoxic effects. Unit of Measure: U/L

  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

  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

  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

  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

  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

  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

  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

  Baseline, Day 14, Day 28, Day 42.

Study Arms (1)

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.

Dietary Supplement: Belinal® (Abies alba branch extract)

Interventions

Belinal® (Abies alba branch extract) DIETARY_SUPPLEMENT

Belinal® capsules, 900 mg/day (4 × 225 mg), orally for 14 consecutive days.

Belinal® Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

University of Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Links

• Belinal® information

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 23, 2025
• Study Start: August 20, 2018
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)