Clinical trial NCT02944084: Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract
Official title: Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Safety After Oral Intake
Pharmacokinetics After Oral Intake
Keywords: Bioavailability
Pharmacokinetics
Rice bran extract
Vitamin E
Gamma-oryzanol
Ferulic acid
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Economics and Technology
First posted: 2016-10-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Time to reach maximum plasma concentration (Tmax) of total ferulic acid [h]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
measure: Time to reach maximum plasma concentration (Tmax) of total gamma-oryzanol [h]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
measure: Cumulative urinary excretion of total Vitamin E metabolites [nmol/g creatinine]
timeFrame: 0-24 h post dose
measure: Cumulative urinary excretion of total ferulic acid [nmol/g creatinine]
timeFrame: 0-24 h post dose
measure: Cumulative urinary excretion of total gamma-oryzanol [nmol/g creatinine]
timeFrame: 0-24 h post dose
Secondary outcomes:
measure: Serum aspartate transaminase activity [U/L]
timeFrame: 0, 4, 24h post-dose
measure: Serum alanine transaminase activity [U/L]
timeFrame: 0, 4, 24h post-dose
measure: Serum gamma-glutamyl transferase activity [U/L]
timeFrame: 0, 4, 24h post-dose
measure: Serum alkaline phosphatase activity [U/L]
timeFrame: 0, 4, 24h post-dose
measure: Serum bilirubin
timeFrame: 0, 4, 24h post-dose
measure: Serum uric acid [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: Serum creatinine [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: Serum total cholesterol [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: Serum HDL cholesterol [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: Serum LDL cholesterol [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: Serum triacylglycerols [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: LDL/HDL cholesterol ratio
timeFrame: 0, 4, 24h post-dose
measure: Glomerular filtration rate [mL/min]
timeFrame: 0, 4, 24h post-dose
measure: Serum glucose [mg/dL]
timeFrame: 0, 24h post-dose
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
state: Baden-Württemberg
Study officials:
affiliation: University of Hohenheim
name: Jan Frank, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: