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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belinal® (Abies alba branch extract) | Dietary Supplement | Belinal® capsules, 900 mg/day (4 × 225 mg), orally for 14 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ljubljana | Ljubljana | 1000 | Slovenia |
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| Label | URL |
|---|---|
| Belinal® information | View source |
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| 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. |