Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract

Study Overview
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Brief Summary
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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.

Official Title
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Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract

Conditions
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Safety After Oral Intake, Pharmacokinetics After Oral Intake

Intervention / Treatment
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* Dietary Supplement: Rice bran extract
* Dietary Supplement: Porridge in water
* Dietary Supplement: Porridge in milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rice bran extract<br>2 g of unprocessed rice bran extract | Dietary Supplement: Rice bran extract<br> <br> |
| Experimental: Porridge in water<br>35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm water | Dietary Supplement: Porridge in water<br> <br> |
| Experimental: Porridge in milk<br>35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm milk (3.8% fat) | Dietary Supplement: Porridge in milk<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase | 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 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] | Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 
| Mean maximum plasma concentration (Cmax) of total gamma-oryzanol [nmol/L] | Total gamma-oryzanol after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 
| 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 ferulic acid [h] | Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase | 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] | Total gamma-oryzanol after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 
| Cumulative urinary excretion of total Vitamin E metabolites [nmol/g creatinine] |  | 0-24 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum aspartate transaminase activity [U/L] |  | 0, 4, 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 | 
| Glomerular filtration rate [mL/min] |  | 0, 4, 24h post-dose | 
| Serum glucose [mg/dL] |  | 0, 24h post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, Pharmacokinetics, Rice bran extract, Vitamin E, Gamma-oryzanol, Ferulic acid