Biomarkers of Oat Product Intake: The BiOAT Marker Study

Study Overview
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Brief Summary
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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.

Official Title
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Biomarkers of Oat Product Intake: The BiOAT Marker Study

Conditions
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Healthy

Intervention / Treatment
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* Other: Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Liquid oat product<br> | Other: Diet<br>* Intervention products consist of two different oat products, one solid and one liquid. The content of oat in the products differs.<br>|
| Other: Solid oat product<br> | Other: Diet<br>* Intervention products consist of two different oat products, one solid and one liquid. The content of oat in the products differs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of avenanthramides and avenacosides and their metabolites. | Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over a 24 h period). | 24 hours | 
| Plasma concentration-time profile over 24h (AUCs) of avenanthramides and avenacosides and their metabolites. | Differences in plasma AUCs between the intake levels for each biomarker candidate. | 24 hours | 
| Urine concentrations of avenanthramides and avenacosides and their metabolites | Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average urine concentration over a 8 h period). | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiome | Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 5 days of intervention products. | 5 days | 
| Plasma metabolites | 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. | 5 days | 
| Urine metabolites | 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. | 24 hours | 
| Blood concentrations of avenanthramides and avenacosides and their metabolites | Evaluate new simple sampling techniques using dried blood spots. | 8 hours |