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Trial record 20 of 29 for:    GUSB

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

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ClinicalTrials.gov Identifier: NCT02944084
Recruitment Status : Completed
First Posted : October 25, 2016
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
German Federal Ministry of Economics and Technology
Information provided by (Responsible Party):
University of Hohenheim

Brief 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.

Condition or disease Intervention/treatment Phase
Safety After Oral Intake Pharmacokinetics After Oral Intake Dietary Supplement: Rice bran extract Dietary Supplement: Porridge in water Dietary Supplement: Porridge in milk Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract
Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : April 2017

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Arm Intervention/treatment
Experimental: Rice bran extract
2 g of unprocessed rice bran extract
Dietary Supplement: Rice bran extract
Experimental: Porridge in water
35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm water
Dietary Supplement: Porridge in water
Experimental: Porridge in milk
35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm milk (3.8% fat)
Dietary Supplement: Porridge in milk



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944084


Locations
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Germany
University of Hohenheim
Stuttgart, Baden-Württemberg, Germany, 70599
Sponsors and Collaborators
University of Hohenheim
German Federal Ministry of Economics and Technology
Investigators
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Principal Investigator: Jan Frank, Prof. Dr University of Hohenheim

Additional Information:
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Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT02944084     History of Changes
Other Study ID Numbers: HS-RBE-2016
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by University of Hohenheim:
Bioavailability
Pharmacokinetics
Rice bran extract
Vitamin E
Gamma-oryzanol
Ferulic acid