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

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 Overview

• Status: Completed
• Conditions: Safety After Oral Intake; Pharmacokinetics After Oral Intake
• Intervention / Treatment: Dietary supplement: Rice bran extract; Dietary supplement: Porridge in water; Dietary supplement: Porridge in milk

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany, 70599
      • University of Hohenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rice bran extract; 2 g of unprocessed rice bran extract	Dietary supplement: 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	Dietary supplement: Porridge in 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)	Dietary supplement: Porridge in milk

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Collaborators: German Federal Ministry of Economics and Technology
• Investigators: Principal Investigator: Jan Frank, Prof. Dr, University of Hohenheim

Publications and helpful links

Helpful Links

• Website of the research group

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): April 1, 2017

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (ESTIMATE): October 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Vitamin E; Bioavailability; Ferulic acid; Rice bran extract; Gamma-oryzanol
• Other Study ID Numbers: HS-RBE-2016