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

University of Hohenheim

Status and phase: Completed; Early Phase 1

Conditions: Safety After Oral Intake; Pharmacokinetics After Oral Intake

Treatments: Dietary Supplement: Rice bran extract; Dietary Supplement: Porridge in water; Dietary Supplement: Porridge in milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02944084

HS-RBE-2016

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Rice bran extract

Experimental group

Description:

2 g of unprocessed rice bran extract

Treatment:

Dietary Supplement: Rice bran extract

Porridge in water

Experimental group

Description:

35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm water

Treatment:

Dietary Supplement: Porridge in water

Porridge in milk

Experimental group

Description:

35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm milk (3.8% fat)

Treatment:

Dietary Supplement: Porridge in milk