Examination of the Bioavailability and Bioactivity of the Two Natural Food Ingredients 6-Prenylnaringenin and 8-Prenylnaringenin.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Cell viability of PBMCs after 6-PN administration
研究概览
简要总结
The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary plant substances, almost exclusively found in hops (Humulus lupulus). Both compounds have known potential biological properties, but poor bioavailability due to their low oral absorption and retention. Our study followed a single dose (500 mg 6- or 8-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods. Plasma, PBMC and urine samples were collected at intervals up to 24 h after intake. Investigators investigated the safety, pharmacokinetics and impact of oral prenylflavonoids on the function of cells of the immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers with blood chemistry values within normal ranges
- •Age: 18-45 years
- •BMI: 19-25 kg/m2
排除标准
- •Pregnancy or lactation
- •Alcohol and/or drug abuse
- •Use of dietary supplements or any medications, except contraceptives
- •Any known malignant, metabolic and endocrine diseases
- •Previous cardiac infarction
- •Participation in a clinical trial within the past 6 weeks prior to recruitment
- •Physical activity of more than 5 h/wk
研究组 & 干预措施
Placebo
Capsules filled with mannitol and silicon dioxide
干预措施: Placebo (Dietary Supplement)
6-prenylnaringenin
500 mg 6-PN plus mannitol and silicon dioxide
干预措施: 6-prenylnaringenin (Dietary Supplement)
8-prenylnaringenin
500 mg 8-PN plus mannitol and silicon dioxide
干预措施: 8-prenylnaringenin (Dietary Supplement)
结局指标
主要结局
Cell viability of PBMCs after 6-PN administration
时间窗: 0, 6, and 24 h post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total 6-prenylnaringenin [nmol/L*h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total 6-PN after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total 6-prenylnaringenin [h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Mean area under the curve (AUC) of plasma concentration vs. time of total 8-prenylnaringenin [nmol/L*h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Mean maximum plasma concentration (Cmax) of total 8-prenylnaringenin [nmol/L]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total 8-prenylnaringenin [h]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Cell count (dead cells/ml and living cells/ml) of PBMCs after 8-PN administration
时间窗: 0, 6, and 24 h post dose
Cumulative urinary excretion of total 8-prenylnaringenin [nmol/g creatinine]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Mean maximum plasma concentration (Cmax) of total 6-prenylnaringenin [nmol/L]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Cumulative urinary excretion of total 6-prenylnaringenin [nmol/g creatinine]
时间窗: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration
时间窗: 0, 6, and 24 h post dose
Cell viability of PBMCs after 8-PN administration
时间窗: 0, 6, and 24 h post dose
次要结局
- Serum LDL cholesterol [mg/dL](0, 4, 24h post-dose)
- Serum triacylglycerols [mg/dL](0, 4, 24h post-dose)
- Monocytes [%](0, 24h post-dose)
- Mean corpuscular volume [fL](0, 24h post-dose)
- Hematocrit [%](0, 24h post-dose)
- Erythrocytes [/pL](0, 24h post-dose)
- Leucocytes [/nL](0, 24h post-dose)
- Serum alanine transaminase activity [U/L](0, 4, 24h post-dose)
- Serum total cholesterol [mg/dL](0, 4, 24h post-dose)
- Mean corpuscular hemoglobin [pg](0, 24h post-dose)
- Thrombocytes [/nL](0, 24h post-dose)
- Serum creatinine [mg/dL](0, 4, 24h post-dose)
- Serum alkaline phosphatase activity [U/L](0, 4, 24h post-dose)
- Serum HDL cholesterol [mg/dL](0, 4, 24h post-dose)
- Serum cystatin C [mg/mL](0, 4, 24h post-dose)
- Glomerular filtration rate [mL/min](0, 4, 24h post-dose)
- Serum glucose [mg/dL](0, 24h post-dose)
- Basophil granulocytes [%](0, 24h post-dose)
- Serum gamma-glutamyl transferase activity [U/L](0, 4, 24h post-dose)
- Mean corpuscular hemoglobin concentration [g/dL](0, 24h post-dose)
- Lymphocytes [%](0, 24h post-dose)
- Serum aspartate transaminase activity [U/L](0, 4, 24h post-dose)
- Serum bilirubin(0, 4, 24h post-dose)
- Serum uric acid [mg/dL](0, 4, 24h post-dose)
- LDL/HDL cholesterol ratio(0, 4, 24h post-dose)
- Hemoglobin [g/dL](0, 24h post-dose)
- Segmented granulocytes [%](0, 24h post-dose)
- Eosinophil granulocytes [%](0, 24h post-dose)