NCT02944084

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

Completed EARLY_PHASE1 Last updated 2 May 2017

What this trial tests

EARLY_PHASE1 trial testing Rice bran extract in Safety After Oral Intake in 12 participants. Completed in 1 April 2017.

Timeline

1 April 2016

Primary endpoint
1 June 2016

1 April 2017

Quick facts

Lead sponsor	University of Hohenheim
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	12
Start date	1 April 2016
Primary completion	1 June 2016
Estimated completion	1 April 2017
Sites	1 location across Germany

Drugs / interventions tested

• Rice bran extract
• Porridge in water
• Porridge in milk

Conditions studied

• Safety After Oral Intake — all drugs for Safety After Oral Intake →
• Pharmacokinetics After Oral Intake — all drugs for Pharmacokinetics After Oral Intake →

Sponsor

University of Hohenheim

Who can join

Adults 18 to 35, any sex, with Safety After Oral Intake or Pharmacokinetics After Oral Intake. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.