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

Pharmacokinetics After Oral Intake Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944084
• Other study ID #: HS-RBE-2016
• Status: Completed
• Phase: Early Phase 1
• First received: October 24, 2016
• Last updated: May 2, 2017
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics After Oral Intake
• Safety After Oral Intake

Intervention

Dietary Supplement:
• Rice bran extract

• Porridge in water

• Porridge in milk

Locations

Country	Name	City	State
Germany	University of Hohenheim	Stuttgart	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Hohenheim	German Federal Ministry of Economics and Technology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cumulative urinary excretion of total Vitamin E metabolites [nmol/g creatinine]		0-24 h post dose
Primary	Cumulative urinary excretion of total ferulic acid [nmol/g creatinine]		0-24 h post dose
Primary	Cumulative urinary excretion of total gamma-oryzanol [nmol/g creatinine]		0-24 h post dose
Secondary	Serum aspartate transaminase activity [U/L]		0, 4, 24h post-dose
Secondary	Serum alanine transaminase activity [U/L]		0, 4, 24h post-dose
Secondary	Serum gamma-glutamyl transferase activity [U/L]		0, 4, 24h post-dose
Secondary	Serum alkaline phosphatase activity [U/L]		0, 4, 24h post-dose
Secondary	Serum bilirubin		0, 4, 24h post-dose
Secondary	Serum uric acid [mg/dL]		0, 4, 24h post-dose
Secondary	Serum creatinine [mg/dL]		0, 4, 24h post-dose
Secondary	Serum total cholesterol [mg/dL]		0, 4, 24h post-dose
Secondary	Serum HDL cholesterol [mg/dL]		0, 4, 24h post-dose
Secondary	Serum LDL cholesterol [mg/dL]		0, 4, 24h post-dose
Secondary	Serum triacylglycerols [mg/dL]		0, 4, 24h post-dose
Secondary	LDL/HDL cholesterol ratio		0, 4, 24h post-dose
Secondary	Glomerular filtration rate [mL/min]		0, 4, 24h post-dose
Secondary	Serum glucose [mg/dL]		0, 24h post-dose

External Links

•   Website of the research group