Biomarkers of Oat Product Intake: The BiOAT Marker Study
- Conditions
- Healthy
- Interventions
- Other: Diet
- Registration Number
- NCT05511077
- Lead Sponsor
- Chalmers University of Technology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Solid oat product Diet - Liquid oat product Diet -
- Primary Outcome Measures
Name Time Method Plasma concentrations of avenanthramides and avenacosides and their metabolites. 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).
Plasma concentration-time profile over 24h (AUCs) of avenanthramides and avenacosides and their metabolites. 24 hours Differences in plasma AUCs between the intake levels for each biomarker candidate.
Urine concentrations of avenanthramides and avenacosides and their metabolites 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 Outcome Measures
Name Time Method Urine metabolites 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.
Blood concentrations of avenanthramides and avenacosides and their metabolites 8 hours Evaluate new simple sampling techniques using dried blood spots.
Gut microbiome 5 days Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 5 days of intervention products.
Plasma metabolites 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.
Trial Locations
- Locations (1)
University of Gothenburg, Department of Food and Nutrition and Sport Science
🇸🇪Gothenburg, Sweden