The Effect of Silver Fir Branch Extract on Liver and Kidney Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in serum AST
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in serum AST
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline, Day 14, Day 28, Day 42.
Change in uric acid levels as a marker of kidney function. Unit of Measure: µmol/L
次要结局
未报告次要终点