Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract
- Conditions
- Pharmacokinetics After Oral IntakeSafety After Oral Intake
- Interventions
- Dietary Supplement: Porridge in milkDietary Supplement: Porridge in waterDietary Supplement: Rice bran extract
- Registration Number
- NCT02944084
- Lead Sponsor
- University of Hohenheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Healthy Volunteers with blood chemistry values within normal ranges
Age 18 to 35 years
BMI 19 to 25 kg per m2
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Porridge in milk Porridge in milk 35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm milk (3.8% fat) Porridge in water Porridge in water 35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm water Rice bran extract Rice bran extract 2 g of unprocessed rice bran extract
- Primary Outcome Measures
Name Time Method Cumulative urinary excretion of total ferulic acid [nmol/g creatinine] 0-24 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 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
Cumulative urinary excretion of total Vitamin E metabolites [nmol/g creatinine] 0-24 h post dose 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 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 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
Cumulative urinary excretion of total gamma-oryzanol [nmol/g creatinine] 0-24 h post dose
- Secondary Outcome Measures
Name Time Method Serum bilirubin 0, 4, 24h post-dose LDL/HDL cholesterol ratio 0, 4, 24h post-dose Serum alanine transaminase activity [U/L] 0, 4, 24h post-dose Serum triacylglycerols [mg/dL] 0, 4, 24h post-dose Serum aspartate transaminase activity [U/L] 0, 4, 24h post-dose Glomerular filtration rate [mL/min] 0, 4, 24h post-dose Serum gamma-glutamyl transferase activity [U/L] 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 alkaline phosphatase activity [U/L] 0, 4, 24h post-dose Serum glucose [mg/dL] 0, 24h post-dose
Trial Locations
- Locations (1)
University of Hohenheim
đŸ‡©đŸ‡ªStuttgart, Baden-WĂ¼rttemberg, Germany