Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Apr 2016
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 24, 2016
CompletedFirst Posted
Study publicly available on registry
October 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMay 3, 2017
May 1, 2017
2 months
October 24, 2016
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Mean area under the curve (AUC) of plasma concentration vs. time of total alfa, beta, gamma and delta tocopherols and tocotrienols [nmol/L*h]
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]
Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase
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]
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]
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Mean maximum plasma concentration (Cmax) of total ferulic acid [nmol/L]
Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Mean maximum plasma concentration (Cmax) of total gamma-oryzanol [nmol/L]
Total gamma-oryzanol after deconjugation with beta-glucuronidase/sulphatase
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]
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Time to reach maximum plasma concentration (Tmax) of total ferulic acid [h]
Total ferulic acid after deconjugation with beta-glucuronidase/sulphatase
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Time to reach maximum plasma concentration (Tmax) of total gamma-oryzanol [h]
Total gamma-oryzanol after deconjugation with beta-glucuronidase/sulphatase
0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Cumulative urinary excretion of total Vitamin E metabolites [nmol/g creatinine]
0-24 h post dose
Cumulative urinary excretion of total ferulic acid [nmol/g creatinine]
0-24 h post dose
Cumulative urinary excretion of total gamma-oryzanol [nmol/g creatinine]
0-24 h post dose
Secondary Outcomes (14)
Serum aspartate transaminase activity [U/L]
0, 4, 24h post-dose
Serum alanine transaminase activity [U/L]
0, 4, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
0, 4, 24h post-dose
Serum alkaline phosphatase activity [U/L]
0, 4, 24h post-dose
Serum bilirubin
0, 4, 24h post-dose
- +9 more secondary outcomes
Study Arms (3)
Rice bran extract
EXPERIMENTAL2 g of unprocessed rice bran extract
Porridge in water
EXPERIMENTAL35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm water
Porridge in milk
EXPERIMENTAL35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm milk (3.8% fat)
Interventions
Eligibility Criteria
You may qualify if:
- Healthy Volunteers with blood chemistry values within normal ranges
- Age 18 to 35 years
- BMI 19 to 25 kg per m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Hohenheim
Stuttgart, Baden-Wurttemberg, 70599, Germany
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Frank, Prof. Dr
University of Hohenheim
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2016
First Posted
October 25, 2016
Study Start
April 1, 2016
Primary Completion
June 1, 2016
Study Completion
April 1, 2017
Last Updated
May 3, 2017
Record last verified: 2017-05