Safety After Oral IntakeEarly Phase 1NCT02944084
Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract
A Early Phase 1 study testing Rice bran extract, Porridge in water and Porridge in milk in people with Safety After Oral Intake and Pharmacokinetics After Oral Intake, run by University of Hohenheim at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety After Oral Intake, Pharmacokinetics After Oral Intake
- What is being tested?
- Rice bran extract, Porridge in water and Porridge in milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Apr 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers with blood chemistry values within normal ranges
- Age 18 to 35 years
- BMI 19 to 25 kg per m2
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Rice bran extract, Porridge in water, Porridge in milk
- Keywords
- Bioavailability, Pharmacokinetics, Rice bran extract, Vitamin E, Gamma-oryzanol, Ferulic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice bran extractDietary supplement
Porridge in waterDietary supplement
Porridge in milkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Rice bran extract | Experimental | 2 g of unprocessed rice bran extract Receives: Dietary Supplement: Rice bran extract |
| Porridge in water | Experimental | 35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm water Receives: Dietary Supplement: Porridge in water |
| Porridge in milk | Experimental | 35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm milk (3.8% fat) Receives: Dietary Supplement: Porridge in milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean area under the curve (AUC) of plasma concentration vs. time of total alfa, beta, gamma and delta tocopherols and tocotrienols [nmol/L*h]
Measured: 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
Measured: 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]
Measured: 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]
Measured: 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
Measured: 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
Measured: 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]
Measured: 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
Measured: 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
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Cumulative urinary excretion of total Vitamin E metabolites [nmol/g creatinine]
Measured: 0-24 h post dose
Cumulative urinary excretion of total ferulic acid [nmol/g creatinine]
Measured: 0-24 h post dose
Cumulative urinary excretion of total gamma-oryzanol [nmol/g creatinine]
Measured: 0-24 h post dose
Secondary outcomes (14)
Serum aspartate transaminase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum alanine transaminase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum bilirubin
Measured: 0, 4, 24h post-dose
Serum uric acid [mg/dL]
Measured: 0, 4, 24h post-dose
Serum creatinine [mg/dL]
Measured: 0, 4, 24h post-dose
Serum total cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum HDL cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum LDL cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum triacylglycerols [mg/dL]
Measured: 0, 4, 24h post-dose
LDL/HDL cholesterol ratio
Measured: 0, 4, 24h post-dose
Glomerular filtration rate [mL/min]
Measured: 0, 4, 24h post-dose
Serum glucose [mg/dL]
Measured: 0, 24h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety After Oral IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Economics and Technology
- Responsible party
- Sponsor
- Investigators
- Jan Frank, Prof. Dr, Principal investigator, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944084
- Sponsor's protocol ID
- HS-RBE-2016
- Status last verified
- May 2017
- First submitted
- 24 Oct 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract
- ClinicalTrials.gov ID
- NCT02944084
- Acronym / sponsor ID
- HS-RBE-2016
- Keywords
- Bioavailability, Pharmacokinetics, Rice bran extract, Vitamin E, Gamma-oryzanol, Ferulic acid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- German Federal Ministry of Economics and Technology
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rice bran extract | Experimental | Dietary Supplement: Rice bran extract2 g of unprocessed rice bran extract |
| Porridge in water | Experimental | Dietary Supplement: Porridge in water35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm water |
| Porridge in milk | Experimental | Dietary Supplement: Porridge in milk35 g of porridge containing 2 g of rice bran extract mixed with 95 ml of warm milk (3.8% fat) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Volunteers with blood chemistry values within normal ranges
- Age 18 to 35 years
- BMI 19 to 25 kg per m2
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rice bran extract | Dietary supplement | Rice bran extract |
| Porridge in water | Dietary supplement | Porridge in water |
| Porridge in milk | Dietary supplement | Porridge in milk |
Primary outcome
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
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
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
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
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
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
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
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
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
Cumulative urinary excretion of total Vitamin E metabolites [nmol/g creatinine]
Time frame: 0-24 h post dose
Cumulative urinary excretion of total ferulic acid [nmol/g creatinine]
Time frame: 0-24 h post dose
Cumulative urinary excretion of total gamma-oryzanol [nmol/g creatinine]
Time frame: 0-24 h post dose
14 secondary outcomes
Serum aspartate transaminase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum alanine transaminase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum bilirubin
Time frame: 0, 4, 24h post-dose
Serum uric acid [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum creatinine [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum total cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum HDL cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum LDL cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum triacylglycerols [mg/dL]
Time frame: 0, 4, 24h post-dose
LDL/HDL cholesterol ratio
Time frame: 0, 4, 24h post-dose
Glomerular filtration rate [mL/min]
Time frame: 0, 4, 24h post-dose
Serum glucose [mg/dL]
Time frame: 0, 24h post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Website of the research groupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Frank, Prof. Dr principal investigator
University of Hohenheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rice bran extract, Porridge in water and Porridge in milk in people with Safety After Oral Intake and Pharmacokinetics After Oral Intake, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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] (time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.