Human HealthNCT04335435
Avenanthramide and Saponin Bioavailability in Oat Bran
A study testing Oat Bran Consumption in people with Human Health and Polyphenols, run by North Carolina Agriculture & Technical State University.
Trial summary
Avenanthramides and saponins are types of chemical compounds found naturally in oats. Avenanthramides have anti-oxidant properties, anti-atherosclerotic, anti-inflammation, and anti-proliferative effects on cancer cells in vitro. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Health, Polyphenols, Pharmacokinetics
- What is being tested?
- Oat Bran Consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 21 Jan 2016
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5-25
- Have blood and urine biochemical markers in normal range
- Have no known allergy to oat relate foods
- Be not taking antibiotics for six months
- Be not currently taking medication
- Be nonsmoking
- Have no alcoholic intoxication
- Have no extensive exposure to industrial waste
Who cannot join
- Individuals with gout
- Individuals with heart disease
- Individuals with peripheral vascular diseases
- Individuals with degenerative liver
- Cancer patients
- Patients with diabetes
- Individuals with GI disorders
- Individuals with endocrine disorders
About this study
Avenanthramides and saponins are types of chemical compounds found naturally in oats.
Avenanthramides have anti-oxidant properties, anti-atherosclerotic, anti-inflammation, and anti-proliferative effects on cancer cells in vitro. Oat saponins, or avenacosides, have the ability to bind cholesterol, and thus, the ability to lower blood cholesterol.
Read more
Oat bran is a known source of these dietary compounds. This study aims to determine the bioavailability of these compounds to in the urine of participants after ingesting an oat bran cereal, both before, and after for multiple time points.
Analytical chemistry will be used to determine the bioavailability of the oat compounds at each time point. This will help to establish a kinetic curve for the metabolism of these compounds.
Read the detailed description
Initially, the diet of the participants will be asked to restricted to avoid eating any polyphenols that might interfere with the employed analytical chemistry techniques. This period of diet restriction is the washout period. The list of foods to avoid are: oats, whole grains, fruits, vegetables, herbal supplements, ginger, coffee, tea, and chocolate.
After the washout period, a baseline urine and fecal sample will be collected from the participants, then a large portion of oat bran will be provided to the participants for consumption. The approximate portion size will be 100 g by dry weight. The participants will then provide urine samples during the designated time points. The time points for the urine collection are as follows:
- st sample, ~ 30 min to 1 hour prior to oat consumption
- nd sample: 0-2 hours after oat consumption
- rd sample: 2-4 hours after oat consumption
- th sample: 4-6 hours after oat consumption
- th sample: 6-9 hours after oat consumption
- th sample: 9-12 hours after oat consumption
- th sample: 12-24 hours after oat consumption
- th sample: 24-32 hours after oat consumption
- th sample: 48 hours after oat consumption These samples will be analyzed in using HPLC and LC/MS.
- Conditions
- Human Health, Polyphenols, Pharmacokinetics
- Being tested
- Oat Bran Consumption
- Keywords
- Avenanthramides, Saponins, bioavailability, polyphenols, oat bran, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat Bran ConsumptionDietary supplement
Also called Gut Microbiome and Oat metabolism Study
Oat bran (120 g), single dose.
| Study group | Role | What they receive |
|---|---|---|
| Oat Bran Consumption | Experimental | Each subject consumed 120 g of oat bran (by dry weight) in a single dose, and samples (urine and fecal) were collected at different time points following the administration of oat bran. Receives: Dietary Supplement: Oat Bran Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of Avenanthramides and Saponins in Urine
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Measured: 0-2 hours post-dose
Bioavailability of Avenanthramides and Saponins in Urine
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Measured: 2-4 hours post-dose
Bioavailability of Avenanthramides and Saponins in Urine
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Measured: 4-6 hours post-dose
Bioavailability of Avenanthramides and Saponins in Urine
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Measured: 6-9 hours post-dose
Bioavailability of Avenanthramides and Saponins in Urine
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Measured: 9-12 hours post-dose
Bioavailability of Avenanthramides and Saponins in Urine
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Measured: 12-24 hours post-dose
Bioavailability of Avenanthramides and Saponins in Urine
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Measured: 24-32 hours post-dose
Bioavailability of Avenanthramides and Saponins in Urine
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Measured: 32-48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start15 Jan 2016
- Primary completion21 Jan 2016
- Study completion21 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human HealthStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina Agriculture & Technical State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengmin Sang, North Carolina Agriculture & Technical State University
- Investigators
- Shengmin Sang, PhD, Principal investigator, North Carolina Agriculture and Technical State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335435
- Sponsor's protocol ID
- 15-0179
- Status last verified
- Aug 2020
- First submitted
- 2 Apr 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang P, Zhang S, Yerke A, Ohland CL, Gharaibeh RZ, Fouladi F, Fodor AA, Jobin C, Sang S. Avenanthramide Metabotype from Whole-Grain Oat Intake is Influenced by Faecalibacterium prausnitzii in Healthy Adults. J Nutr. 2021 Jun 1;151(6):1426-1435. doi: 10.1093/jn/nxab006.
PubMed 33694368
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avenanthramide and Saponin Bioavailability in Oat Bran
- ClinicalTrials.gov ID
- NCT04335435
- Acronym / sponsor ID
- 15-0179
- Conditions
- Human Health, Polyphenols, Pharmacokinetics
- Keywords
- Avenanthramides, Saponins, bioavailability, polyphenols, oat bran, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- North Carolina Agriculture & Technical State UniversityUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 21 Jan 2016 (actual)
- Study completion
- 21 Jan 2016 (actual)
- First posted
- 6 Apr 2020 (actual)
- 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.
Avenanthramides and saponins are types of chemical compounds found naturally in oats.
Avenanthramides have anti-oxidant properties, anti-atherosclerotic, anti-inflammation, and anti-proliferative effects on cancer cells in vitro. Oat saponins, or avenacosides, have the ability to bind cholesterol, and thus, the ability to lower blood cholesterol.
Oat bran is a known source of these dietary compounds. This study aims to determine the bioavailability of these compounds to in the urine of participants after ingesting an oat bran cereal, both before, and after for multiple time points.
Analytical chemistry will be used to determine the bioavailability of the oat compounds at each time point. This will help to establish a kinetic curve for the metabolism of these compounds.
Detailed description
Initially, the diet of the participants will be asked to restricted to avoid eating any polyphenols that might interfere with the employed analytical chemistry techniques. This period of diet restriction is the washout period. The list of foods to avoid are: oats, whole grains, fruits, vegetables, herbal supplements, ginger, coffee, tea, and chocolate.
After the washout period, a baseline urine and fecal sample will be collected from the participants, then a large portion of oat bran will be provided to the participants for consumption. The approximate portion size will be 100 g by dry weight. The participants will then provide urine samples during the designated time points. The time points for the urine collection are as follows:
- st sample, ~ 30 min to 1 hour prior to oat consumption
- nd sample: 0-2 hours after oat consumption
- rd sample: 2-4 hours after oat consumption
- th sample: 4-6 hours after oat consumption
- th sample: 6-9 hours after oat consumption
- th sample: 9-12 hours after oat consumption
- th sample: 12-24 hours after oat consumption
- th sample: 24-32 hours after oat consumption
- th sample: 48 hours after oat consumption These samples will be analyzed in using HPLC and LC/MS.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oat Bran Consumption | Experimental | Dietary Supplement: Oat Bran ConsumptionEach subject consumed 120 g of oat bran (by dry weight) in a single dose, and samples (urine and fecal) were collected at different time points following the administration of oat bran. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- BMI 18.5-25
- Have blood and urine biochemical markers in normal range
- Have no known allergy to oat relate foods
- Be not taking antibiotics for six months
- Be not currently taking medication
Key exclusion criteria (8 listed)
- Individuals with gout
- Individuals with heart disease
- Individuals with peripheral vascular diseases
- Individuals with degenerative liver
- Cancer patients
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 |
|---|---|---|
| Oat Bran ConsumptionAlso: Gut Microbiome and Oat metabolism StudyOat bran (120 g), single dose. | Dietary supplement | Oat Bran Consumption |
Primary outcome
Bioavailability of Avenanthramides and Saponins in Urine
Time frame: 0-2 hours post-dose
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Bioavailability of Avenanthramides and Saponins in Urine
Time frame: 2-4 hours post-dose
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Bioavailability of Avenanthramides and Saponins in Urine
Time frame: 4-6 hours post-dose
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Bioavailability of Avenanthramides and Saponins in Urine
Time frame: 6-9 hours post-dose
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Bioavailability of Avenanthramides and Saponins in Urine
Time frame: 9-12 hours post-dose
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Bioavailability of Avenanthramides and Saponins in Urine
Time frame: 12-24 hours post-dose
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Bioavailability of Avenanthramides and Saponins in Urine
Time frame: 24-32 hours post-dose
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
Bioavailability of Avenanthramides and Saponins in Urine
Time frame: 32-48 hours post-dose
Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.
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 6 Aug 2020.
- Derived from this study: PubMed 33694368Wang P, Zhang S, Yerke A, Ohland CL, Gharaibeh RZ, Fouladi F, Fodor AA, Jobin C, Sang S. Avenanthramide Metabotype from Whole-Grain Oat Intake is Influenced by Faecalibacterium prausnitzii in Healthy Adults. J Nutr. 2021 Jun 1;151(6):1426-1435. doi: 10.1093/jn/nxab006.
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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.
Shengmin Sang, PhD principal investigator
North Carolina Agriculture and Technical State University
Questions about this trial
What is this clinical trial studying?
A study testing Oat Bran Consumption in people with Human Health and Polyphenols, run by North Carolina Agriculture & Technical State University.
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 8 inclusion and 8 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 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Bioavailability of Avenanthramides and Saponins in Urine (time frame: 0-2 hours post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335435, which also lists 1 linked publication.
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 6 Aug 2020.