Silver Fir Safety in Healthy Volunteers

University of Ljubljana15 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Safety / Toxicology Liver Function Kidney Function Dietary Supplement Healthy Volunteers

Interventions

Belinal® (Abies alba branch extract)DIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

University of Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

Change in serum AST

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

Time frame: 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