Pharmacokinetics After Oral Intake, Safety After Oral Intake
Conditions
Keywords
Bioavailability, Pharmacokinetics, Rice bran extract, Vitamin E, Gamma-oryzanol, Ferulic acid
Brief summary
The oral absorption and urinary excretion kinetics of the bioactive ingredients from rice bran (gamma-oryzanol, tocotrienols, tocopherols and ferulic acid esters) after incorporation into an oat porridge (oat porridge) compared to unprocessed rice bran extract oil were investigated. The influence of the type of preparation (with water vs. milk) of porridge on the bioavailability of the bioactive compounds was compared. The study followed a single dose (2 g rice bran extract), randomized, three armed crossover study design with ≥1-week washout periods. Plasma and urine samples were collected at intervals up to 24 h after intake.
Interventions
DIETARY_SUPPLEMENTRice bran extract
DIETARY_SUPPLEMENTPorridge in water
DIETARY_SUPPLEMENTPorridge in milk
Sponsors
German Federal Ministry of Economics and Technology
University of Hohenheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Volunteers with blood chemistry values within normal ranges Age 18 to 35 years BMI 19 to 25 kg per m2
Exclusion criteria
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 Dementia Participation in a clinical trial within the past 1 week prior to recruitment Smoking Physical activity of more than 5 h per wk Lactose intolerance Milk intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative urinary excretion of total Vitamin E metabolites [nmol/g creatinine] | 0-24 h post dose | — |
| Time to reach maximum plasma concentration (Tmax) of total ferulic acid [h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase |
| Time to reach maximum plasma concentration (Tmax) of total gamma-oryzanol [h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | Total gamma-oryzanol after deconjugation with beta-glucuronidase/sulphatase |
| Mean area under the curve (AUC) of plasma concentration vs. time of total alfa, beta, gamma and delta tocopherols and tocotrienols [nmol/L*h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | — |
| Mean area under the curve (AUC) of plasma concentration vs. time of total ferulic acid [nmol/L*h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase |
| Mean area under the curve (AUC) of plasma concentration vs. time of total gamma-oryzanol [nmol/L*h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | — |
| Mean maximum plasma concentration (Cmax) of total total alfa, beta, gamma and delta tocopherols and tocotrienols [nmol/L] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | — |
| Mean maximum plasma concentration (Cmax) of total ferulic acid [nmol/L] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase |
| Mean maximum plasma concentration (Cmax) of total gamma-oryzanol [nmol/L] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | Total gamma-oryzanol after deconjugation with beta-glucuronidase/sulphatase |
| Time to reach maximum plasma concentration (Tmax) of total alfa, beta, gamma and delta tocopherols and tocotrienols [h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | — |
| Cumulative urinary excretion of total ferulic acid [nmol/g creatinine] | 0-24 h post dose | — |
| Cumulative urinary excretion of total gamma-oryzanol [nmol/g creatinine] | 0-24 h post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Glomerular filtration rate [mL/min] | 0, 4, 24h post-dose |
| Serum aspartate transaminase activity [U/L] | 0, 4, 24h post-dose |
| Serum glucose [mg/dL] | 0, 24h post-dose |
| Serum alanine transaminase activity [U/L] | 0, 4, 24h post-dose |
| Serum gamma-glutamyl transferase activity [U/L] | 0, 4, 24h post-dose |
| Serum alkaline phosphatase 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 |
| Serum creatinine [mg/dL] | 0, 4, 24h post-dose |
| Serum total cholesterol [mg/dL] | 0, 4, 24h post-dose |
| Serum HDL cholesterol [mg/dL] | 0, 4, 24h post-dose |
| Serum LDL cholesterol [mg/dL] | 0, 4, 24h post-dose |
| Serum triacylglycerols [mg/dL] | 0, 4, 24h post-dose |
| LDL/HDL cholesterol ratio | 0, 4, 24h post-dose |
Countries
Germany
Outcome results
None listed