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Completed

NCT Number: NCT04335435

Avenanthramide and Saponin Bioavailability in Oat Bran

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.

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Key information

Conditions

Human Health Pharmacokinetics Polyphenols

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oat Bran Consumption

Dietary Supplement

Oat bran (120 g), single dose.

Other names: Gut Microbiome and Oat metabolism Study

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

North Carolina Agriculture & Technical State University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2020
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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