CompletedEarly Phase 1

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

Germany12 participantsStarted 2016-04

Plain-language summary

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.

Who can participate

Age range18 Years – 35 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean area under the curve (AUC) of plasma concentration vs. time of total alfa, beta, gamma and delta tocopherols and tocotrienols [nmol/L*h]

Timeframe: 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]

Timeframe: 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]

Timeframe: 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]

Timeframe: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

Mean maximum plasma concentration (Cmax) of total ferulic acid [nmol/L]

Timeframe: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

Mean maximum plasma concentration (Cmax) of total gamma-oryzanol [nmol/L]

Timeframe: 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]

Timeframe: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

Trial details

NCT IDNCT02944084

SponsorUniversity of Hohenheim

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Safety After Oral Intake trials

Plain-language summary

Who can participate

Age range18 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean area under the curve (AUC) of plasma concentration vs. time of total alfa, beta, gamma and delta tocopherols and tocotrienols [nmol/L*h]

Timeframe: 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]

Timeframe: 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]

Timeframe: 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]

Timeframe: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

Mean maximum plasma concentration (Cmax) of total ferulic acid [nmol/L]

Timeframe: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

Mean maximum plasma concentration (Cmax) of total gamma-oryzanol [nmol/L]

Timeframe: 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]

Timeframe: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose