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Completed

NCT Number: NCT02944084

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.

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Key information

Conditions

Safety After Oral Intake Pharmacokinetics After Oral Intake

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rice bran extract

Dietary Supplement

Porridge in water

Dietary Supplement

Porridge in milk

Dietary Supplement

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Time to reach maximum plasma concentration (Tmax) of total alfa, beta, gamma and delta tocopherols and tocotrienols [h]

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

  8. Time to reach maximum plasma concentration (Tmax) of total ferulic acid [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

  9. Time to reach maximum plasma concentration (Tmax) of total gamma-oryzanol [h]

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

    Total gamma-oryzanol after deconjugation with beta-glucuronidase/sulphatase

  10. Cumulative urinary excretion of total Vitamin E metabolites [nmol/g creatinine]

    Time frame: 0-24 h post dose

  11. Cumulative urinary excretion of total ferulic acid [nmol/g creatinine]

    Time frame: 0-24 h post dose

  12. Cumulative urinary excretion of total gamma-oryzanol [nmol/g creatinine]

    Time frame: 0-24 h post dose

Secondary outcomes

  1. Serum aspartate transaminase activity [U/L]

    Time frame: 0, 4, 24h post-dose

  2. Serum alanine transaminase activity [U/L]

    Time frame: 0, 4, 24h post-dose

  3. Serum gamma-glutamyl transferase activity [U/L]

    Time frame: 0, 4, 24h post-dose

  4. Serum alkaline phosphatase activity [U/L]

    Time frame: 0, 4, 24h post-dose

  5. Serum bilirubin

    Time frame: 0, 4, 24h post-dose

  6. Serum uric acid [mg/dL]

    Time frame: 0, 4, 24h post-dose

  7. Serum creatinine [mg/dL]

    Time frame: 0, 4, 24h post-dose

  8. Serum total cholesterol [mg/dL]

    Time frame: 0, 4, 24h post-dose

  9. Serum HDL cholesterol [mg/dL]

    Time frame: 0, 4, 24h post-dose

  10. Serum LDL cholesterol [mg/dL]

    Time frame: 0, 4, 24h post-dose

  11. Serum triacylglycerols [mg/dL]

    Time frame: 0, 4, 24h post-dose

  12. LDL/HDL cholesterol ratio

    Time frame: 0, 4, 24h post-dose

  13. Glomerular filtration rate [mL/min]

    Time frame: 0, 4, 24h post-dose

  14. Serum glucose [mg/dL]

    Time frame: 0, 24h post-dose

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Collaborators

  • German Federal Ministry of Economics and Technology

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Oct 25, 2016
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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