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

NCT ID: NCT02944084

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-04-30

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.

Detailed Description

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Conditions

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Safety After Oral Intake Pharmacokinetics After Oral Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Rice bran extract

2 g of unprocessed rice bran extract

Group Type EXPERIMENTAL

Rice bran extract

Intervention Type DIETARY_SUPPLEMENT

Porridge in water

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

Group Type EXPERIMENTAL

Porridge in water

Intervention Type DIETARY_SUPPLEMENT

Porridge in milk

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

Group Type EXPERIMENTAL

Porridge in milk

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Rice bran extract

Intervention Type DIETARY_SUPPLEMENT

Porridge in water

Intervention Type DIETARY_SUPPLEMENT

Porridge in milk

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Federal Ministry of Economics and Technology

OTHER_GOV

Sponsor Role collaborator

University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Frank, Prof. Dr

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim

Locations

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University of Hohenheim

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Related Links

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http://www.nutrition-research.de/

Website of the research group

Other Identifiers

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HS-RBE-2016

Identifier Type: -

Identifier Source: org_study_id

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