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Completed

NCT Number: NCT05511077

Biomarkers of Oat Product Intake: The BiOAT Marker Study

The aim of this project is to evaluate avenanthramides and avenacosides and their metabolites as specific biomarkers of oat product intake in humans. Biomarkers will be evaluated after i) a single dose through a single meal based on a solid and a liquid oat-based product (pharmacokinetic study) ii) week-long consumption at three different intake levels (dose-response). The study will be carried out as a two-way cross-over design with two different oat products, liquid or solid, where each product is provided 3 times per day during 5 days per product. A wash-out period of 8 days where participants consume their habitual diet is implemented. The first day of study meal intervention includes postprandial measurements during 8 hours.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Gothenburg, Department of Food and Nutrition and Sport Science

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Females and males
  • Age 18-80 years
  • Body mass index (BMI) 18.5-30 kg/m2
  • Fasting glucose ≤ 6.1 mmol/l
  • Low density lipoprotein (LDL) Cholesterol ≤ 5.30 mmol/L
  • Triglycerides ≤ 2.60 mmol/L
  • Signed informed consent

Exclusion criteria

  • Food allergies or intolerances preventing consumption of any products included in the study.
  • Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
  • Pregnant, lactating or planning a pregnancy during the study period.
  • Antibiotic use for the last 3 months.
  • Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
  • History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
  • Previous major gastrointestinal surgery
  • Have type I diabetes
  • Thyroid disorder

Treatment and study plan

Diet

Other

Intervention products consist of two different oat products, one solid and one liquid. The content of oat in the products differs.

Primary outcomes

  1. Plasma concentrations of avenanthramides and avenacosides and their metabolites.

    Time frame: 24 hours

    Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over a 24 h period).

  2. Plasma concentration-time profile over 24h (AUCs) of avenanthramides and avenacosides and their metabolites.

    Time frame: 24 hours

    Differences in plasma AUCs between the intake levels for each biomarker candidate.

  3. Urine concentrations of avenanthramides and avenacosides and their metabolites

    Time frame: 8 hours

    Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average urine concentration over a 8 h period).

Secondary outcomes

  1. Gut microbiome

    Time frame: 5 days

    Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 5 days of intervention products.

  2. Plasma metabolites

    Time frame: 5 days

    Untargeted metabolomics will be performed using established methods for plasma. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect oats product intake. Baseline compared with after intervention products.

  3. Urine metabolites

    Time frame: 24 hours

    Untargeted metabolomics will be performed using established methods for urine. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect oats product intake.

  4. Blood concentrations of avenanthramides and avenacosides and their metabolites

    Time frame: 8 hours

    Evaluate new simple sampling techniques using dried blood spots.

Sponsors and collaborators

Lead sponsor

Chalmers University of Technology

Other

Collaborators

  • Oatly Group Inc

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 22, 2022
Registry last updated
Feb 21, 2023

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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