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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

Interventions

  • Dietary Supplement: Rice bran extract
  • Dietary Supplement: Porridge in water
  • Dietary Supplement: Porridge in milk

Arms, Groups and Cohorts

  • Experimental: Rice bran extract
    • 2 g of unprocessed rice bran extract
  • Experimental: Porridge in water
    • 35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm water
  • Experimental: Porridge in milk
    • 35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm milk (3.8% fat)

Clinical Trial Outcome Measures

Primary Measures

  • Mean area under the curve (AUC) of plasma concentration vs. time of total alfa, beta, gamma and delta tocopherols and tocotrienols [nmol/L*h]
    • Time Frame: 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]
    • Time Frame: 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]
    • Time Frame: 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]
    • Time Frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
  • Mean maximum plasma concentration (Cmax) of total ferulic acid [nmol/L]
    • Time Frame: 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]
    • Time Frame: 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]
    • Time Frame: 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]
    • Time Frame: 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]
    • Time Frame: 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 Vitamin E metabolites [nmol/g creatinine]
    • Time Frame: 0-24 h post dose
  • Cumulative urinary excretion of total ferulic acid [nmol/g creatinine]
    • Time Frame: 0-24 h post dose
  • Cumulative urinary excretion of total gamma-oryzanol [nmol/g creatinine]
    • Time Frame: 0-24 h post dose

Secondary Measures

  • Serum aspartate transaminase activity [U/L]
    • Time Frame: 0, 4, 24h post-dose
  • Serum alanine transaminase activity [U/L]
    • Time Frame: 0, 4, 24h post-dose
  • Serum gamma-glutamyl transferase activity [U/L]
    • Time Frame: 0, 4, 24h post-dose
  • Serum alkaline phosphatase activity [U/L]
    • Time Frame: 0, 4, 24h post-dose
  • Serum bilirubin
    • Time Frame: 0, 4, 24h post-dose
  • Serum uric acid [mg/dL]
    • Time Frame: 0, 4, 24h post-dose
  • Serum creatinine [mg/dL]
    • Time Frame: 0, 4, 24h post-dose
  • Serum total cholesterol [mg/dL]
    • Time Frame: 0, 4, 24h post-dose
  • Serum HDL cholesterol [mg/dL]
    • Time Frame: 0, 4, 24h post-dose
  • Serum LDL cholesterol [mg/dL]
    • Time Frame: 0, 4, 24h post-dose
  • Serum triacylglycerols [mg/dL]
    • Time Frame: 0, 4, 24h post-dose
  • LDL/HDL cholesterol ratio
    • Time Frame: 0, 4, 24h post-dose
  • Glomerular filtration rate [mL/min]
    • Time Frame: 0, 4, 24h post-dose
  • Serum glucose [mg/dL]
    • Time Frame: 0, 24h post-dose

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Hohenheim
  • Collaborator
    • German Federal Ministry of Economics and Technology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jan Frank, Prof. Dr, Principal Investigator, University of Hohenheim

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