Clinical trial NCT04335435: Avenanthramide and Saponin Bioavailability in Oat Bran
Official title: Avenanthramide and Saponin Bioavailability in Oat Bran
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Health
Polyphenols
Pharmacokinetics
Keywords: Avenanthramides
Saponins
bioavailability
polyphenols
oat bran
pharmacokinetics
Lead sponsor: North Carolina Agriculture & Technical State University
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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. 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:

1. st sample, \~ 30 min to 1 hour prior to oat consumption
2. nd sample: 0-2 hours after oat consumption
3. rd sample: 2-4 hours after oat consumption
4. th sample: 4-6 hours after oat consumption
5. th sample: 6-9 hours after oat consumption
6. th sample: 9-12 hours after oat consumption
7. th sample: 12-24 hours after oat consumption
8. th sample: 24-32 hours after oat consumption
9. th sample: 48 hours after oat consumption These samples will be analyzed in using HPLC and LC/MS.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Bioavailability of Avenanthramides and Saponins in Urine
timeFrame: 0-2 hours post-dose
measure: Bioavailability of Avenanthramides and Saponins in Urine
timeFrame: 2-4 hours post-dose
measure: Bioavailability of Avenanthramides and Saponins in Urine
timeFrame: 4-6 hours post-dose
measure: Bioavailability of Avenanthramides and Saponins in Urine
timeFrame: 6-9 hours post-dose
measure: Bioavailability of Avenanthramides and Saponins in Urine
timeFrame: 9-12 hours post-dose
measure: Bioavailability of Avenanthramides and Saponins in Urine
timeFrame: 12-24 hours post-dose
measure: Bioavailability of Avenanthramides and Saponins in Urine
timeFrame: 24-32 hours post-dose
measure: Bioavailability of Avenanthramides and Saponins in Urine
timeFrame: 32-48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: North Carolina Agriculture and Technical State University
name: Shengmin Sang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.