Silver Fir Safety in Healthy Volunteers

University of Ljubljana

Status: Completed

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

Treatments: Dietary Supplement: Belinal® (Abies alba branch extract)

Study type: Interventional

Funder types: Other

Identifiers

NCT07189143

0120-642/2017/5

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Belinal® Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Belinal® (Abies alba branch extract)