Dietary Supplement, Healthy Volunteers, Kidney Function, Liver Function, Safety / Toxicology
Conditions
Keywords
Abies alba, Silver fir extract, Dietary supplement, Safety
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).
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.
Interventions
DIETARY_SUPPLEMENTBelinal® (Abies alba branch extract)
Belinal® capsules, 900 mg/day (4 × 225 mg), orally for 14 consecutive days.
Sponsors
University of Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum AST | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline, Day 14, Day 28, Day 42. | Change in uric acid levels as a marker of kidney function. Unit of Measure: µmol/L |
Countries
Slovenia
Outcome results
None listed