Clinical Trials Directory

Trials / Completed

CompletedNCT07189143

Silver Fir Safety in Healthy Volunteers

The Effect of Silver Fir Branch Extract on Liver and Kidney Function

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
University of Ljubljana · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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).

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTBelinal® (Abies alba branch extract)Belinal® capsules, 900 mg/day (4 × 225 mg), orally for 14 consecutive days.

Timeline

Start date
2018-08-20
Primary completion
2018-10-29
Completion
2018-10-29
First posted
2025-09-23
Last updated
2025-09-23

Locations

1 site across 1 country: Slovenia

Source: ClinicalTrials.gov record NCT07189143. Inclusion in this directory is not an endorsement.